What We Know, What We Don’t About the Omicron Variant

NOV 30 2021

A new COVID-19 variant known as Omicron has global health officials concerned as scientists race to discover how mutations will impact the transmission and severity of the virus. Here’s what we know. Omicron, officially known as B.1.1.529, was designated a variant of concern on November 26 by the World Health Organization (WHO). The designation was made based on evidence presented to the WHO's Technical Advisory Group on Virus Evolution that Omicron has several mutations that may affect how the variant behaves, ie, the severity of disease it causes, its degree of transmissibility, and the variant's immune escape potential — that is, whether it can bypass protection offered by current COVID-19 vaccines. Omicron was first identified in South Africa and reported to the WHO on November 24; it has now been detected in Australia, Belgium, Botswana, Britain, Denmark, Germany, Hong Kong, Israel, Italy, the Netherlands, France, Canada, and South Africa. At least 44 countries have imposed travel restrictions from several African countries, reports CNN. Japan and Israel have banned all foreign nationals from entering their countries. Health officials in Canada confirmed the country's first 2 cases in Ottawa, November 28. There have been 50 mutations identified in the B.1.1.529 lineage, the most concerning being more than 30 in the spike protein region, the area that facilitates a virus' entry into the host cell, enhancing its transmissibility as well as the potential for immunoescape. WHO notes, however, that it is not clear yet whether the variant is more transmissible compared to other recent variants, including Delta. While the number of persons testing positive for Omicron has increased in areas of South Africa where circulation has been identified, studies have been launched to understand if the variant is to blame or if other factors may be implicated. There are as yet no data to clarify whether Omicron causes more severe disease compared to other variants, and WHO again points to Delta as the primary comparator. “Preliminary data suggest that there are increasing rates of hospitalization in South Africa, but this may be due to increasing overall numbers of people becoming infected, rather than a result of specific infection with Omicron,” states WHO. Nor is there any suggestion that symptoms associated with Omicron infection are different from those seen with currently circulating variants. According to a report from Reuters, a South African physician who was among the first clinicians to suspect a different strain of the coronavirus among patients he saw said that “the symptoms of the Omicron variant were so far mild and could be treated at home.” The chair of South African Medical Association, also speaking, said that no patients so far have reported loss of smell or taste and there has been no major drop in oxygen levels observed. According to WHO, initial reported infections were among university students who overall tend to have milder infection and symptoms. Better understanding of both infectivity and transmissibility of Omicron will likely take several weeks, the WHO stressed, as will accruing information on whether the variant can potentially render current vaccinations less effective. “Work is already under way to look at the immune escape potential of B.1.1.529 in the laboratory setting,” note scientists with South Africa’s National Institute for Communicable Diseases (NICD) in a statement. “Based on our understanding of the mutations in this lineage, partial immune escape is likely, but it is likely that vaccines will still offer high levels of protection against hospitalization and death.” Effectiveness of current tests is currently not in question, according to WHO, as the widely used PCR assays continue to detect infection, including with Omicron. Research is underway to assess any potential impact of the variant on other tests including rapid antigen detection tests. Treatments for COVID-19 also are being assessed for efficacy against Omicron infection but WHO stresses that both corticosteroids and IL-1 receptor antagonists will continue to be effective against severe COVID-19. In statements, leaders from both Pfizer-BioNTech and Moderna said virus mutations have been anticipated since the beginning and that the companies are working closely with authorities to process information as soon as it is available.

Merck's COVID-19 Pill May Be Less Effective Than First Hoped

NOV 30 2021

Merck’s antiviral pill for COVID-19, molnupiravir, appears to be far less effective than early results from the clinical trial first suggested. According to an analysis by scientists at the FDA, the experimental pill cut the risk of hospitalization or death from COVID-19 by about 30%, compared to a placebo, and the pill showed no benefit for people with antibodies against COVID-19 from prior infection. The updated analysis showed 48 hospitalizations or deaths among study participants who were randomly assigned to take the antiviral drug, compared to 68 among those who took a placebo. Those results come from the full set of 1,433 patients who were randomized in the clinical trial, which just became available last week. Initial results from the first 775 patients enrolled in the clinical trial, which were issued in a company news release in October, had said the drug cut the risk of hospitalization or death for patients at high risk of severe disease by about 50%. Merck has been producing millions of doses of molnupiravir, which is the first antiviral pill to treat COVID-19 infections. The United Kingdom’s drug regulator authorized use of the medication in early November. The company said it expected to distribute the medication globally by the end of 2021. Last month, two Indian drug companies halted late-stage clinical trials of a generic version of molnupiravir after the studies failed to find any benefit to patients with moderate COVID-19. Trials in patients with milder symptoms are still ongoing. TheNew England Journal of Medicine postponed its planned early release of the molnupiravir study results, citing “new information.” The medication is designed to be given as four pills taken every 12 hours for 5 days. It’s most effective when taken within the first few days of new symptoms, something that requires convenient and affordable testing. The new results seem to put molnupiravir far below the effectiveness of existing treatments.

COVID-19 Breath Test Being Developed

OCT 28 2021

Instead of an invasive nasal swab, researchers at The Ohio State University Wexner Medical Center are exploring the use of a unique breath test for the rapid screening of patients for COVID-19. Results from the initial study in patients, published today in the journal PLOS ONE, found the breath test is highly accurate in identifying COVID-19 infections in critically ill patients. "The gold standard for diagnosis of COVID-19 is a PCR test that requires an uncomfortable nasal swab and time in a lab to process the sample and obtain the results,” said Dr Matthew Exline, lead researcher, director of critical care at Ohio State Wexner Medical Center University Hospital and professor of internal medicine at The Ohio State University College of Medicine. “The breathalyzer test used in our study can detect COVID-19 within seconds.” COVID-19 infection produces a distinct breath print from the interaction of oxygen, nitric oxide and ammonia in the body. The breath detector device, developed by Pelagia-Irene Gouma, researcher and professor in the Department of Materials Science and Engineering and the Department of Mechanical and Aerospace Engineering at The Ohio State University and Milutin Stanaćević, associate professor in the Department of Electrical and Computer Engineering at Stony Brook University, can detect the breath print of COVID-19 in exhaled breath within 15 seconds. “This novel breathalyzer technology uses nanosensors to identify and measure specific biomarkers in the breath,” said Gouma. “This is the first study to demonstrate the use of a nanosensor breathalyzer system to detect a viral infection from exhaled breath prints.” The study followed 46 patients in the intensive care unit with acute respiratory failure that required mechanical ventilation. Half of the patients had an active COVID-19 infection and the remaining half didn’t have COVID-19. All patients had a PCR COVID-19 test when they were admitted to the unit. Researchers collected exhaled breath bags from the patients on day 1, 3, 7 and 10 of their inpatient stay. The breath bag samples were tested within 4 hours of sample collection in a lab. The breath print was identified in patients with COVID-19 pneumonia with 88% accuracy upon admission to the ICU. “PCR tests often miss early COVID-19 infections and results can be positive after the infection has resolved,” Exline said. “However, this noninvasive breath test technology can pick up early COVID-19 infection within 72 hours of the onset of respiratory failure, allowing us to rapidly screen patients in a single step and exclude those without COVID-19 on mechanical ventilation.” The use of breathalyzer technology to rapidly diagnose patients with respiratory infections has the potential to greatly improve the ability to rapidly screen both patients and asymptomatic people. Future studies will look at the use of this technology for less severe COVID-19 patients and will explore whether other diseases and infections could benefit from it. The research team has applied to the U.S. Food and Drug Administration for emergency use authorization of the breathalyzer technology.

Doctors Divided About Need for COVID-19 Boosters: Poll

Sep 15 2021

Current scientific evidence does not indicate that people who are not immunocompromised need booster shots of COVID-19 vaccines, a team of experts write in a viewpoint article in The Lancet. Research shows that the vaccines remain effective at preventing severe COVID-19, according to the group of experts. They include two high-level officials in the office of the US Food and Drug Administration that regulates vaccines who recently announced plans to leave the agency. Doctors and nurses in the United States are divided about the need for COVID-19 boosters and about how the United States should prioritize its supply of vaccines, according to a Medscape poll of more than 1700 clinicians that collected responses from August 25 to September 6. Overall, 71% of 575 US physicians who were polled said they thought the available evidence supports giving boosters to people who have already had two doses of the Moderna or Pfizer COVID-19 vaccines; 12% disagreed, and 17% said they were unsure. Of 1133 nurses surveyed, 66% said they thought evidence supports boosters, 15% disagreed, and 19% were unsure. More than three fourths of the 348 male physician respondents said they believed the evidence supports boosters; 64% of their female colleagues (208 were polled) shared this view. Responses varied by age: 74% of physicians and 70% of nurses aged 55 and older said they believed the evidence supports boosters. Fewer of their younger colleagues (61% of doctors and 56% of nurses) agreed. Doctors based outside the United States were significantly less likely than US doctors to say the evidence supports boosters. Only 42% of about 200 doctors based outside the United States thought boosters are needed; 32% said the evidence doesn't support boosters, and 27% said they were unsure.

Among 853 Swedish men and women (mean age, 22 years) who were part of a birth cohort study, there were no significant differences in either forced expiratory volume in 1 second (FEV1) or in the ratio of FEV1 to forced vital capacity, reported Ida Mogensen, MD, PhD, a postdoctoral fellow at the Karolinska Institute, in Stockholm, Sweden.

"We found no effect of COVID-19 on spirometric lung function in generally healthy adults," she said in oral abstract presented at the European Respiratory Society (ERS) 2021 International Congress, which was held online.

The findings echo those of a small study that involved 73 children and adolescents with COVID-19 and 45 uninfected control persons. The investigators in that study, which was also presented at ERS 2021, found that there were no significant differences in the frequency of abnormal pulmonary function measures between case patients and control patients (abstract OA1303).

"The findings from these two studies provide important reassurance about the impact of COVID infection on lung function in children and young adults," commented Anita Simonds, MD, an honorary consultant in respiratory and sleep medicine at the Royal Brompton Hospital, London, United Kingdom.

"We know already that this group is less likely to suffer severe illness if they contract the virus, and these studies, which importantly include comparator groups without COVID-19, show that they are also less likely to suffer long-term consequences with respect to lung function," she said. Simonds was not involved in either study.

COVID-19 Spares Lung Function in Young Adults

Sep 15 2021

Here's some encouraging news for once regarding SARS-CoV-2 infections: a study of young adults for whom prepandemic spirometry data were available showed that COVID-19 did not have a significant impact on lung function, even among patients with asthma. Among 853 Swedish men and women (mean age, 22 years) who were part of a birth cohort study, there were no significant differences in either forced expiratory volume in 1 second (FEV1) or in the ratio of FEV1 to forced vital capacity, reported Ida Mogensen, MD, PhD, a postdoctoral fellow at the Karolinska Institute, in Stockholm, Sweden. "We found no effect of COVID-19 on spirometric lung function in generally healthy adults," she said in oral abstract presented at the European Respiratory Society (ERS) 2021 International Congress, which was held online. The findings echo those of a small study that involved 73 children and adolescents with COVID-19 and 45 uninfected control persons. The investigators in that study, which was also presented at ERS 2021, found that there were no significant differences in the frequency of abnormal pulmonary function measures between case patients and control patients (abstract OA1303). "The findings from these two studies provide important reassurance about the impact of COVID infection on lung function in children and young adults," commented Anita Simonds, MD, an honorary consultant in respiratory and sleep medicine at the Royal Brompton Hospital, London, United Kingdom. "We know already that this group is less likely to suffer severe illness if they contract the virus, and these studies, which importantly include comparator groups without COVID-19, show that they are also less likely to suffer long-term consequences with respect to lung function," she said. Simonds was not involved in either study.

FDA Authorizes Booster Shot for Immunocompromised Americans

Aug 13 2021

The US Food and Drug Administration has authorized a third dose of COVID-19 vaccines by Pfizer Inc (PFE.N)-BioNTech and Moderna Inc (MRNA.O) for people with compromised immune systems. The amended emergency use authorization paves the way for people who have had an organ transplant, or those with a similar level of weakened immune system, to get an extra dose of the same shot they have initially received. Mixing of mRNA vaccines is permitted for the third shot if their original vaccine is not available. An advisory panel to the US Centers for Disease Control and Prevention (CDC) on Friday voted to recommend the additional doses, an important step before the policy is implemented. Patients will not need a prescription or the sign off of a health care provider in order to prove they are immunocompromised and receive the additional dose, according to CDC officials. “It will be a patient’s attestation, and there will be no requirement for proof or prescription or a recommendation from an individual’s health care provider,” CDC official Dr Amanda Cohn said, speaking before the Advisory Committee on Immunization Practice vote. The vulnerable group makes up less than 3% of U.S. adults, Rochelle Walensky, director of the CDC, had said before the authorization. “After a thorough review of the available data, the FDA determined that this small, vulnerable group may benefit from a third dose of the Pfizer-BioNTech or Moderna vaccines,” Janet Woodcock, U.S. FDA’s acting commissioner, said in a tweet. Woodcock said that others who are fully vaccinated do not need an additional vaccine dose right now.

Tachycardia Syndrome May Be a Distinct Marker for Long COVID

Aug 13 2021

Tachycardia is commonly reported in patients with post-acute COVID-19 syndrome (PACS), also known as long COVID, authors report in a new article. The researchers say tachycardia syndrome should be considered a distinct phenotype. The study by Marcus Ståhlberg, MD, PhD, of Karolinska University Hospital, Stockholm, Sweden, and colleagues was published online August 11 in The American Journal of Medicine. Ståhlberg said that although much attention has been paid to cases of clotting and perimyocarditis in patients after COVID, relatively little attention has been paid to tachycardia, despite case reports that show that palpitations are a common complaint. “We have diagnosed a large number of patients with postural orthostatic tachycardia syndrome [POTS] and other forms of COVID-related tachycardia at our post-COVID outpatient clinic at Karolinska University Hospital and wanted to highlight this phenomenon,” he said. Between 25% and 50% of patients at the clinic report tachycardia and/or palpitations that last 12 weeks or longer, the authors report. “Systematic investigations suggest that 9% of Post-acute Covid-19 syndrome patients report palpitations at six months,” the authors write. The findings also shed light on potential tests and treatments, he said. “Physicians should be liberal in performing a basic cardiological workup, including an ECG [electrocardiogram], echocardiography, and Holter ECG monitoring in patients complaining of palpitations and/or chest pain,” Ståhlberg said.

Highlighting the Effectiveness of the COVID-19 Vaccines Could Convert Doubters

JUL 13 2021

Informing people about how well the new COVID-19 vaccines work could boost uptake among doubters substantially, according to new research. The study, led by the University of Bristol and published in the British Journal of Health Psychology, shows the importance of raising awareness of vaccine efficacy, especially if it compares very favourably to another well-established vaccine. The research focused on adults who were unsure about being vaccinated against COVID-19. Those who were given information about the vaccine’s efficacy scored 20 per cent higher on a measure of willingness to be vaccinated, compared to those who received no information. This improved receptivity increased by as much as double among survey respondents who were also given information about how COVID-19 vaccines perform in comparison to the annual flu vaccine. Lead author Professor Colin Davis, Chair in Cognitive Psychology at the university’s School of Psychological Science, said: “The general positive effect of providing key information is not surprising, as we knew already that people’s perception of the effectiveness of a vaccine is an important factor in their vaccination intentions. But the extra benefit of providing comparative information is a novel finding which underscores the vital role of communication in improving vaccine uptake.” The findings come from two surveys of UK adults, aged between 18 and 85, last December. The first survey of 2,400 people revealed that 65 per cent agreed or strongly agreed they would have the COVID-19 vaccine, which at the time wasn’t widely available. A further 12 per cent were equally sure that they would not take the vaccine. However, in the middle range were around a quarter (23 per cent) of respondents who expressed reservations and uncertainty about whether they would be vaccinated. A second survey of 481 of those fence-sitters followed, which aimed to discover whether providing certain relevant information might nudge them to overcome their hesitancy and be more inclined to be vaccinated. When no information was given, the majority of the participants were unsure about having the vaccine. Confidence levels grew by some 20 per cent when they were told of the overwhelming efficacy of the Pfizer and Moderna vaccines, 95 per cent and 94 per cent respectively at the time. Their likelihood of being vaccinated grew by a similar margin again, when the information about the COVID-19 vaccine also stated the effectiveness of the flu vaccine over the past 15 years, according to the US Centers for Disease Control, which stands at some 40 per cent. “The findings show the positive potential of the contrast effect. Pointing out factual comparisons can be helpful when making a decision, particularly about something new. People value evidence-based information and this can provide affirmation and reassurance for cautious groups,” Professor Davis said. “It’s also important to note the information we provided about the lower effectiveness of the flu jab did not change people’s intention to have the flu vaccine. Perception of the flu vaccine benefits from its familiarity and an established sense of safety and efficacy. By positively associating the COVID-19 vaccine with the well-known flu jab, people are reminded that vaccines work and they are safe.” The latest figures show vaccine uptake is slowing. Over the last two months the average number of vaccine doses being administered daily has dropped from over half a million doses a day to just under a third of a million. This reflects a much lower rate of uptake among younger groups. In England while at least 95 per cent of 55 to 79-year-olds have had their first dose and at least 80 per cent of those aged 35 and above, the figure drops to some 76 per cent among 30 to 35-year-olds, 65 per cent for 25 to 29-year-olds, and just 57 per cent of 18 to 24-year-olds, according to latest NHS England data. Professor Davis said: “Younger people perhaps perceive themselves to be less vulnerable to COVID-19 virus. While mortality rates are fortunately much lower in this age group, exposure to the virus carries the danger of long-COVID in people of all ages. By getting vaccinated young people can protect themselves and also reduce transmission levels in the population as a whole. The vaccination campaign is by no means over and this study shows the importance of informed and targeted communication.”

Pfizer, Moderna Vaccine Protection May Last Months, or Longer

JUN 30 2021

Pfizer and Moderna's COVID-19 vaccines may provide protection against the virus for months — and much longer for those who had been infected and were later vaccinated, according to a new study. The study, published in the journal Nature, found either vaccine provided robust protection for at least 12 weeks following a second dose and could provide low-level protection for at least a year. Researchers say their study showed the vaccines provide "robust and prolonged" protection. The New York Times reported that researchers on this and other studies suggest COVID immunity might last for years, or even a lifetime, in people who had COVID, recovered, and were vaccinated. The researchers, led by Ali H. Ellebedy, PhD, of the Department of Pathology and Immunology at Washington University School of Medicine in St Louis, warn that variants of the virus that emerge in the future could change the effectiveness of the vaccines.

Respiratory Infection RSV Surges in South as Mask Use, Distancing Decline

JUN 30 2021

Doctors in Georgia and other Southern states have seen since April an unusual surge of a common respiratory virus that affects children and older adults. The spike in cases of respiratory syncytial virus (RSV) at this time of year is linked, at least in part, to children and others no longer widely wearing masks or social distancing to prevent COVID-19 infection, experts say. When masks began coming off, "we knew we'd see a really bad RSV season,'' said Dr Stephen Thacker, a pediatric infectious disease specialist in Savannah."Kids are getting infected at the same time.'' Thacker said the virus swept through his own household, starting with his youngest child. "I got it, too,'' he told GHN on Thursday. The CDC this month issued an advisory about the rise of RSV, which can lead to severe disease in young children and older adults. It's primarily spread via respiratory droplets when a person coughs or sneezes, and through direct contact with a contaminated surface. RSV is the most common cause of pneumonia and bronchiolitis (inflammation and congestion of the small airways in the lungs) in children under a year old in the United States. Each year in the US, the virus leads to an average of about 58,000 hospitalizations, with 100 to 500 deaths among children younger than 5 years old; and 177,000 hospitalizations with 14,000 deaths among adults aged 65 years or older. The virus is generally a leading cause of hospitalization for children in the nation. The risk is worse for children born prematurely and those with heart conditions or immune system problems, Thacker added. Fortunately, most people who get it, including infants, develop only mild symptoms like those of a common cold, such as congestion, runny nose, and coughing, the American Lung Association in Georgia said.

Almost All US COVID-19 Deaths Now in the Unvaccinated

JUN 30 2021

If you, a friend or a loved one remain unvaccinated against COVID-19 at this point – for whatever reason – you are at higher risk for dying if you do become infected. That's the conclusion of a new report The Associated Press released looking at COVID-19 deaths during May 2021. Of more than 18,000 people who died from COVID-19, for example, only about 150 were fully vaccinated. That's less than 1%. "Recently I was working in the emergency room [and] I saw a 21-year-old African- American who came in with shortness of breath," says Vino K. Palli, MD, a doctor specializing in emergency medicine, internal medicine and urgent care. The patient deteriorated rapidly and required ventilation. She was transferred to a specialized hospital for in case she needed what’s known as ECMO treatment, where blood is pumped outside your body to remove carbon dioxide. "This patient was unvaccinated along with her entire family. This would have been easily preventable," says Palli, who is also founder and CEO of MiDoctor Urgent Care in New York City. "Vaccine misinformation compounded with vaccine inertia and vaccine access has contributed to this," he says. “Even though we have a surplus amount of vaccines at this time we are only seeing 50 to 55% off completely vaccinated patients.” The AP report authors also acknowledge that some people who are fully vaccinated can get a “breakthrough infection” of COVID-19. These occurred in fewer than 1,200 of more than 853,000 people hospitalized for COVID-19 in May, or about 0.1%. The AP came up with these numbers using CDC data. The CDC tracks the numbers of cases, hospitalizations and deaths, but does not break down rates by vaccination status. "The fact that only 0.8% of COVID-19 deaths are in the fully vaccinated should persuade those people still hesitant about vaccination," says Hugh Cassiere, MD, medical director of Respiratory Therapy Services at North Shore University Hospital in Manhasset, NY. Stuart C. Ray, MD, professor of Medicine and Oncology in the Division of Infectious Diseases at Johns Hopkins University School of Medicine in Baltimore, says. "It seems compelling, even for skeptics, that unvaccinated people represent 99% of those now dying from COVID-19, when they represent less than 50% of the adult population in the USA." The findings from the study could be more persuasive than previous arguments made in favor of immunization, Ray says. "These recent findings of striking reductions in risk of death in the vaccinated are more directly attributable and harder to ignore or dismiss." Brian Labus, PhD, of the University of Nevada Las Vegas is less convinced. "While this might change some peoples' minds, it probably won't make a major difference. People have many different reasons for not getting vaccinated, and this is only one of the things they consider."

Thrombosis With Thrombocytopenia After mRNA COVID-19 Vaccine

JUN 30 2021

What is believed to be the first case of thrombosis with thrombocytopenia after a messenger RNA COVID-19 vaccine has been reported. The case report is described in a letter to Annals of Internal Medicine published online today. A group led by Swathi Sangli, MBBS, Allegheny Health Network, Pittsburgh, Pennsylvania, describe what they say appears to be the development of vaccine-induced thrombosis with thrombocytopenia (VITT) or thrombocytopenia with thrombosis syndrome (TTS) in a 65-year-old man who had received a second dose of the Moderna mRNA-1273 vaccine 10 days before the onset of symptoms. The patient presented with 1 week of bilateral lower-extremity discomfort, intermittent headaches, and 2 days of dyspnea. He had no known prior heparin exposure. He was found to have large, bilateral, acute pulmonary emboli with right ventricular strain and acute deep venous thromboses in both lower extremities. The patient had severe thrombocytopenia, so it was decided not to give systemic anticoagulation and an inferior vena cava filter was placed. The patient received two doses of intravenous immunoglobulin followed by 40 mg of dexamethasone intravenously for 4 days for presumed immune-mediated thrombocytopenia. Unfractionated heparin therapy was initiated after platelet transfusions elevated his platelet count, but 3 days later, the patient developed an acute gluteal hematoma requiring withdrawal of heparin. The thrombocytopenia persisted, and on evaluation for heparin-induced thrombocytopenia (HIT), the anti-platelet factor 4/heparin IgG assay was strongly positive. Twelve hours later, he developed acute encephalopathy, and a CT scan showed cerebral venous sinus thrombosis. The lower-extremity deep venous thromboses progressed and a new upper-extremity deep venous thrombosis occurred. Blood cultures also showed methicillin-sensitive Staphylococcus aureus and antibiotics were given. Bivalirudin treatment and plasmapheresis was started but the patient continued to deteriorate and died. After his death, serum collected during admission (but before he received heparin) was strongly positive for anti-platelet factor 4/heparin IgG. The authors say that, in retrospect, this patient met the criteria for VITT, and the likelihood of this diagnosis is strengthened by the positive platelet factor 4 test of the blood drawn before heparin administration. "Although we believe the evidence supporting VITT in this case is robust, we cannot rule out atypical HIT or HIT with unrecorded heparin administration," they state. "Had we suspected VITT earlier, we would have treated the patient differently," they note, giving bivalirudin (or another recommended nonheparin anticoagulant) earlier, avoiding platelet transfusions, and conducting more extensive serologic testing of platelet-activating antibodies, as guidelines recommend. "In summary, we believe it is important to note that many millions of people have received COVID-19 vaccines that use mRNA technology. This is the only report to date of possible VITT or TTS in those recipients, and such a rare event, even if confirmed by additional reports, should not prevent persons from receiving the benefits of these vaccines," the authors write.

Getinge Gets FDA Clearance

JUN 24 2021

Getinge announces clearance from the US FDA of several new software options for the Servo-u and Servo-n ventilators. In addition to the latest software upgrades, Getinge also received clearance for the new Servo-u MR ventilator for the MRI room. “The COVID-19 pandemic and the heightened awareness of respiratory health has driven the need for personalized ventilation solutions for critically ill patients. Now more than ever, options for personalized lung protection and personalized weaning solutions are at the forefront of respiratory patient health. Getinge strives to support clinicians and patients by optimizing lung protection and delivering solutions for personalized ventilation,” said Eric Honroth, President, Getinge North America. With this software upgrade for the Servo-u and Servo-n combined, Getinge adds several new functionalities and options across all patient categories – adult, pediatric and neonatal. Getinge broadens its portfolio of lung-protective tools, including Automatic Stepwise Recruitment maneuver (Auto SRM), a standardized and automated workflow that guides lung recruitment and helps clinicians identify a personalized PEEP that provides the lowest driving pressure, which is a variable strongly associated with patient survival in ARDS1. Stress index and Transpulmonary pressure monitoring, including key parameters for assessment of lung stress during controlled and spontaneous ventilation, complements the lung protective toolkit, which was designed to optimally divide the cognitive workload between the clinician and the ventilator. Additionally, the clearance includes Heliox therapy. Heliox is a mixture of helium and oxygen that facilitates laminar flow and minimizes airway pressure due to its low density. This helps reduce the work of breathing (WoB) of patients suffering from obstructive lung diseases. Getinge also received clearance to introduce the Servo-u MR to the US market, a complement to the Servo Family, expanding Getinge’s platform of ventilators into the MRI room. Designed to guide the ventilator into a safe position, the Servo-u MR includes a magnetic field indicator with visual and audible alerts and an auto-lock handle that locks all four wheels as soon as the clinician releases the ventilator. “We are seeing a transformation in the way healthcare providers view respiratory health,” said Eric Honroth. “With this clearance, we are excited to be part of driving this transformation, working hand in hand with experts and clinicians.” Getinge remains committed to innovation in ventilation platforms. With its rich legacy of firsts, Getinge is proud to bring innovative products and solutions to clinicians through this most recent 510k clearance. The new options and the Servo-u MR ventilator are expected to be available in the US in July 2021.

EMA Launches Review of Clot Risk With AstraZeneca COVID Vaccine

MAR 15 2021

The Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is investigating cases of thromboembolic events related to AstraZeneca’s COVID-19 vaccine, but says the benefits currently still outweigh risks. As of March 10, 30 cases of thromboembolic events had been reported among nearly 5 million people vaccinated with the AstraZeneca vaccine in the European Economic Area, which includes European Union (EU) countries as well as Iceland, Liechtenstein, and Norway. The Danish Health Authority paused its vaccination campaign with the AstraZeneca vaccine last week as a precautionary measure while they investigate reports of blood clots in people who received the vaccine, including one individual who died, the EMA noted in a statement March 12. Now, several other European countries have temporarily stopped using the AstraZeneca vaccine based on similar reports, including Italy, Germany, France, the Netherlands and Ireland. The EMA issued an update today saying that suspending these vaccination campaigns are “a precaution taken in the light of their national situation while EMA investigates a number of events of blood clots in people who have received the vaccine.” Events involving blood clots, some with “unusual features” such as low numbers of platelets, have occurred in a “very small number” of people who received the vaccine, the new statement notes, and the number of events overall in vaccinated people “seems not to be higher than that seen in the general population.” The agency is working with AstraZeneca, experts in blood disorders, and other health authorities, including the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), where around 11 million doses have already been administered. “EMA’s investigation has been continuing over the weekend, and rigorous analysis of all the data related to thromboembolic events will be carried out in the coming days,” the agency notes. “Experts are looking in great detail at all the available data and clinical circumstances surrounding specific cases to determine whether the vaccine might have contributed or if the event is likely to have been due to other causes.”

At-Home COVID-19 Testing: Convenience, Cost, and Some Caveats

MAR 15 2021

At-home testing for COVID-19 features great convenience, but pathology experts caution that false positives, false negatives, out-of-pocket costs, and the potential for inadequate sampling from people swabbing their own noses or mouths could compromise results. Experts agree that COVID-19 testing has had its challenges and has evolved over the past year. “It’s a very, very significant day,” Kisha Mitchell Richards, MD, FCAP, director of pathology and laboratory at Greenwich Hospital, Greenwich, Connecticut, said at a March 11 webinar on COVID-19. The webinar was sponsored by the College of American Pathologists (CAP). “It’s one year ago today that the World Health Organization declared COVID-19 a pandemic and basically set in stone a year that was going to change our lives probably forever,” Richards said. During that time, “PCR testing” became more of a household term, community and preoperative testing changed and expanded, and more at-home tests gained emergency use authorization from the US Food and Drug Administration (FDA). Among them is the first molecular-based at-home test, which was approved earlier. However, the number and nuances of COVID-19 tests have left some people with questions. “People are still having difficulty understanding the tests. This may be due to the shift in focus to the vaccines and/or being overwhelmed and confused by the amount of information available,” said Patrick Godbey, MD, FCAP, president of CAP and laboratory director of Southeastern Pathology Associates and Southeast Georgia Health System, Brunswick, Georgia.

Vaccinators Put Squeeze on FDA to Relax Vaccine Handling Advice

MAR 15 2021

President Joe Biden has promised enough covid vaccine to immunize every willing adult by June 1. But the gap between supply and demand has been so dramatic that vaccinators discoveried ways to suck the final drops out of each vaccine vial — if federal regulators will let them. Pharmacists involved in the covid vaccination drive say it’s common to have half a dose left in a Pfizer vial after five or even six doses have been administered — and to have half a dose left after 10 doses have been drawn out of a Moderna vial. Combining two half-doses could increase vaccinations by thousands at a time when 2 million or so doses are being administered every day in the country. So, they want to use a single hypodermic needle to withdraw leftover vaccine from two vials from which all full doses already have been removed. The American Society of Health-System Pharmacists asked the Food and Drug Administration consider granting permission to do so in a recent letter. The governors of Colorado and Oregon also have sought permission to allow their pharmacists to pool covid vaccine vials. Federal health regulators, however, have long opposed the reuse of drug vials because of the risk of introducing a bacterial contaminant. From 1998 to 2014 more than 50 outbreaks of viral or bacterial disease were reported as a result of unsafe injection practices, including injecting multiple patients with a drug from the same vial. The FDA wouldn’t comment on the pharmacists’ letter but restated to KHN its current policy that “doses not be pooled from different vaccine vials, especially for coronavirus vaccines, which are not formulated with a preservative.” On its website, the Centers for Disease Control and Prevention explicitly tells vaccinators to discard vials “when there is not enough vaccine to obtain a complete dose. Do NOT combine residual vaccine from multiple vials to obtain a dose.” “It’s a recipe for disaster,” said Ann Marie Pettis, president of the Association for Professionals in Infection Control and Epidemiology. There is always a tiny chance that one of the two vials has previously been contaminated, which would contaminate a shot that combined their contents, she said. Spokespeople for both Moderna and Pfizer said excess portions of their vaccines must be discarded and never pooled. Johnson & Johnson had no comment on the issue.

Online COVID-19 Symptom Checkers May Not Catch Severe Illnesses

MAR 15 2021

Digital COVID-19 symptom checkers in the US and the UK may fail to identify severe COVID-19 and other serious illnesses such as bacterial pneumonia or sepsis, according to a group of public-health researchers. The online tools often advise patients to stay home and may prevent them from getting prompt treatment, the team writes in BMJ Health and Care Informatics. “As a frontline COVID doctor myself, I was concerned that the symptom checker was delaying the presentation of patients with severe COVID-19 to the hospital, and this was adding to the pressure on higher-dependency areas, such as” intensive-care units (ICUs), said senior author Dr Daniel Goyal of the Gibraltar Health Authority and Gibraltar’s COVID-19 Research Group. “The earlier we can identify pneumonia, the easier it is to facilitate recovery,” he told Reuters Health by email. “If patients present late, then they have higher mortality, higher rates of ICU admissions, longer admission, and they take much longer to recover, if they survive.” Dr Goyal and his colleagues ran a simulation study in April 2020 on nationwide symptom checkers in the U.S., UK, Japan and Singapore. They used 52 cases that represented typical COVID-19 presentations, including mild, moderate, severe and critical cases, as well as COVID-19 “mimickers” such as bacterial pneumonia and sepsis. The case scenarios included symptoms such as cough, fever and shortness of breath, along with underlying conditions, immunosuppression, age, symptom severity and symptom duration. They compared the recommendations, including whether patients were advised to seek medical care or stay at home. Overall, the research team found that the Japan and Singapore checkers were twice as likely to recommend medical care. About 88% of the Singapore cases were triaged onward, followed by 77% in Japan, 44% in the UK and 38% in the .S. Both the UK and US tools consistently failed to identify severe COVID-19, bacterial pneumonia and sepsis, often advising patients to stay at home and not seek care. The Singapore and Japan symptom checkers recommended clinical assessment after four days of symptoms, whereas the U.S. and the UK tools didn’t change based on the duration of symptoms. Age also didn’t appear to affect the recommendations in the U.S. or U.K., but all patients in Singapore over age 65 with viral symptoms and all “older adults” in Japan who had viral symptoms for more than two days were advised to seek medical care.

Fauci Worries About Possible Post-COVID ‘Mental Health Pandemic’

MAR 15 2021

Anthony Fauci, MD, says he’s concerned about how Americans will react once the coronavirus pandemic is brought under control, CBS News reports. Noting that an American Psychological Association survey showed people reporting high stress levels because of the pandemic, CBS’s Norah O’Donnell asked if Fauci was worried about a possible “mental health pandemic.” “Very much so,” Fauci, director of the National Institute of Allergy and Infectious Diseases and a top White House coronavirus advisor, replied. “That’s the reason why I want to get the virological aspect of this pandemic behind us as quickly as we possibly can because the long-term ravages of this are so multifaceted,” Fauci said. Some of the problems could include prolonged physical symptoms and the economic effects of the pandemic, he said. “And then the other things: Not only the mental health effects, but many people have put off routine types of medical examinations that they normally would have done,” Fauci said. “I hope we don’t see an increase in some preventable situations that would not have happened if people had the normal access to medical care, which clearly was interrupted by the shutdown associated with COVID-19.” The American Psychological Association released the survey results Thursday in what many people consider the 1-year anniversary of the start of the coronavirus pandemic. “The prolonged stress experienced by adults, especially the high levels of stress reported by Americans directly linked to the pandemic, is seriously affecting mental and physical health, including changes to weight, sleep and alcohol use,” the APA said in a news release.

First Pill for COVID-19 Could Be Ready by Year’s End

MAR 15 2021

New pills to treat patients with COVID-19 are currently in midstage clinical trials and, if successful, could be ready by the end of the year. Only one treatment — remdesivir (Veklury) — has been fully approved by the US Food and Drug Administration (FDA) for patients in the hospital and it must be administered intravenously. Hopes for a day when patients with COVID-19 can take a pill to rid their bodies of the virus got a boost over the weekend when early trial results were presented at a medical conference. Interim phase 2 results for the oral experimental COVID-19 drug molnupiravir, designed to do for patients with COVID-19 what oseltamivir (Tamiflu) can do for patients with the flu, were presented at the Conference on Retroviruses and Opportunistic Infections (CROI) 2021 Annual Meeting. In the small study, the pill significantly reduced infectious virus in patients who were symptomatic and had tested positive for COVID-19 during the previous 4 days but were not hospitalized. After 5 days of treatment, no participants who received molnupiravir had detectable virus, whereas 24% who received placebo did. Two other oral agents are being developed by RedHill Biopharma: one for severe COVID-19 infection for hospitalized patients, and one for patients at home with mild infection. The first, opaganib (Yeliva), proceeded to a phase 2/3 global trial for hospitalized patients after the company announced topline safety and efficacy data in December. In phase 2, the drug was shown to be safe in patients requiring oxygen and effectively reduced the need for oxygen by the end of the treatment period.

California Leaders Look to Reopening, Push 1-Shot Vaccine

MAR 15 2021

California officials are contemplating what things will look like in the nation’s most populous state once millions of people are vaccinated and they move to phase out restrictions on gatherings and businesses that have altered life for a year. When officials last summer designed the four-tiered, yellow-to-purple system California now uses to decide whether people can dine indoors, go to the movies or gather with friends, they did not include a green tier — a recognition that a return to normalcy after the pandemic was far off. Now, Gov. Gavin Newsom’s administration is preparing to add one. “The likelihood of hitting that green tier is probably sooner than some of us thought when we were looking at the summer and fall,” Dr Mark Ghaly, California’s health secretary, said. State officials rely on a complicated formula, including virus spread, to determine which activities are restricted in each county. But a green designation won’t mean “go” for all things. Ghaly said such a label would still mean wearing masks and staying physically distant. He declined in an interview to offer more specifics on what restrictions would be maintained or to provide a threshold of vaccinations the state hopes to meet to allow such a go-ahead. State Public Health Director Dr Tomas Aragón forecast that California could achieve herd immunity when about 75% of the population has been vaccinated, though that could change as the virus mutates. That officials are optimistic enough to publicly discuss a green tier puts California in a dramatically different place than it was a few weeks ago during the state’s worst surge. Now case rates, hospitalizations and deaths are on the decline and vaccinations are on the rise.

CDC’s ‘Huge Mistake’

MAR 15 2021

Since the start of the pandemic, the most terrifying task in health care was thought to be when a doctor put a breathing tube down the trachea of a critically ill covid patient. Those performing such “aerosol-generating” procedures, often in an intensive care unit, got the best protective gear even if there wasn’t enough to go around, per Centers for Disease Control and Prevention guidelines. And for anyone else working with covid patients, until a month ago, a surgical mask was considered sufficient. A new wave of research now shows that several of those procedures were not the most hazardous. Recent studies have determined that a basic cough produces about 20 times more particles than intubation, a procedure one doctor likened to the risk of being next to a nuclear reactor. Other new studies show that patients with covid simply talking or breathing, even in a well-ventilated room, could make workers sick in the CDC-sanctioned surgical masks. The studies suggest that the highest overall risk of infection was among the front-line workers — many of them workers of color — who spent the most time with patients earlier in their illness and in sub-par protective gear, not those working in the covid ICU. “The whole thing is upside down the way it is currently framed,” said Dr Michael Klompas, a Harvard Medical School associate professor who called aerosol-generating procedures a “misnomer” in a recent paper in the Journal of the American Medical Association. “It’s a huge mistake,” he said. The growing body of studies showing aerosol spread of covid-19 during choir practice, on a bus, in a restaurant and at gyms have caught the eye of the public and led to widespread interest in better masks and ventilation. Yet the topic has been highly controversial within the health care industry. For over a year, international and US nurse union leaders have called for health workers caring for possible or confirmed covid patients to have the highest level of protection, including N95 masks. But a widespread group of experts have long insisted that N95s be reserved for those performing aerosol-generating procedures and that it’s safe for front-line workers to care for covid patients wearing less-protective surgical masks. Such skepticism about general aerosol exposure within the health care setting have driven CDC guidelines, supported by national and California hospital associations. The guidelines still say a worker would not be considered “exposed” to covid-19 after caring for a sick covid patient while wearing a surgical mask. Yet in recent months, Klompas and researchers in Israel have documented that workers using a surgical mask and face shield have caught covid during routine patient care.

COVID-19 Isolation and an Infant’s Immune System

MAR 15 2021

Queirra Fenderson, a first-time mom in Fort Washington, MD, gave birth to her daughter, Arya, at the end of December 2019. On the advice of their pediatrician, she and her husband spent the first month of their daughter’s life living in a “bubble” with only a few close family and friends seeing their baby to protect her from germs during cold and flu season. Right about the time the new parents were ready to start exposing Arya to more people and germs, the pandemic hit. So a year later, their 14-month-old still remains in that bubble. “There are still people to this day, some are my closest friends, who haven’t met her yet. It’s crazy,” Fenderson says. She says she and her husband have often wondered how this isolation is impacting their daughter’s developing immune system. They’ve even considered day care to boost her immunity, but balancing that against the risk of COVID-19 has led them to still keep her home. “Arya hasn’t been sick her whole entire life, and I want her to get more exposure to germs to boost her immunity. But in my gut, I’m afraid of the exposure to COVID, too,” Fenderson says. “Pandemic parenting is hard.” Simone Christensen of California agrees. She’s been very cautious with her 9-week-old daughter, Scout, who has seen only a few family members since she was born. Christensen has asthma, and their pediatrician has stressed the need to be cautious about COVID-19. But she and her husband also worry how isolation is impacting their daughter’s immune system. “Scout hasn’t really been exposed to much at this point, which seems crazy because I feel like at this age, I was probably sucking on a table at McDonald’s,” she says with a laugh. “Anytime you talk to someone who raised their child pre-pandemic, they always tell you how important it is to expose babies to germs so their immune system starts to build up, and I always thought I’d be the kind of mom who does that. But everything is different because of COVID. The risks are so much greater, and trying to figure out what’s best in a pandemic is scary and hard.” Leana Wen, MD, is an emergency room doctor and a public health expert. She’s also a mom whose second child — a 10-month-old girl — was born during the pandemic. She says there’s good reason to be cautious with babies and what you expose them to early in life. “Newborns are highly susceptible to illnesses,” she says. “They don’t have much of an immune system of their own, so even pre-pandemic, we advised people to be very careful to germ exposure with newborns, understanding that they develop more robust immune systems over time.” But many others, like B. Brett Finlay, PhD, a Canadian microbiologist and professor of microbiology at the University of British Columbia, also stress that early exposure to microbes has been shown to help a baby’s immune system develop well. “We’ve learned over the last decade or so that the normal development of the immune system absolutely requires the presence of normal microbes,” says Finlay, co-author of Let Them Eat Dirt: Saving Your Child from an Oversanitized World. “It makes a difference in childhood development, and lack of exposure to these good microbes affects allergies, asthma, eczema, obesity, and more,” We don’t know everything about how the immune system is built, “but we do know the end result is you need these early life microbes to get normal immune system development.” This question, often referred to as the hygiene hypothesis, was first raised in 1989, and it has long caused controversy and debate. It argues that the developed world’s focus on clean environments through the use of disinfectants, sanitizers, and bleach has a negative impact on the immune system. The FDA points out it is one of many explanations for “for asthma being the most common chronic disease in the developed world.” But plenty of others aren’t so sure. Researchers who published a study in 2016 found “no good evidence that hygiene, as the public understands, is responsible for the clinically relevant changes to microbial exposures.” The study, published in Perspectives in Public Health, says a combination of things, including “natural childbirth, breast feeding, increased social exposure through sport, other outdoor activities, less time spent indoors, diet and appropriate antibiotic use, may help restore the microbiome and perhaps reduce risks of allergic disease.” The hygiene hypothesis theorizes that cleanliness and lack of exposure to microbes have led to increased allergies, asthma, and other conditions.

New Device Delivers Warmed Respiratory Gases to Spontaneously Breathing Patients

MAR 4 2021

Masimo announced the US introduction of softFlow, innovative pulmonary care therapy which provides nasal high-flow warmed and humidified respiratory gases to spontaneously breathing patients. The technology, available on the softFlow 50, offers adult patients high-flow respiratory support through a soft nasal cannula by generating a consistent high flow of warm, humidified air or air/oxygen mixture. As the COVID-19 pandemic continues, increasing the number of patients suffering from respiratory conditions and requiring respiratory support, softFlow offers clinicians across the continuum of care an important tool to help in the treatment of spontaneously breathing patients. Capable of operating without an external compressed air supply, softFlow is designed for maximum versatility, with utility in settings throughout the hospital, long term-care facilities, and use at home. To reduce the risk of cross-contamination, softFlow uses a single-patient-use flow path from the internal mixing chamber to the patient and a bacterial/viral filter designed to filter contaminants from the air delivered to the patient. The US National Institutes of Health (NIH) and World Health Organization (WHO) have both suggested that the use of High-Flow Nasal Cannula (HFNC) therapy, like softFlow, is a viable option for providing respiratory support for select COVID-19 patients for whom conventional oxygen therapy may be insufficient. softFlow can provide patients suffering from COVID-19 or other respiratory conditions with higher flow rates of oxygen than conventional oxygen therapies. As a therapy, NIH concluded, “HFNC is preferred over Noninvasive Positive Pressure Ventilation (NIPPV) in patients with acute hypoxemic respiratory failure based on data from an unblinded clinical trial in patients without COVID-19 who had acute hypoxemic respiratory failure.” The referenced study found a higher number of ventilator-free days (24 days) with HFNC than with conventional oxygen therapy (22 days) or NIPPV (19 days) (p=0.02). The researchers also found a lower 90-day mortality rate compared to conventional oxygen therapy or NIPPV. With softFlow, the airflow is consistently delivered through the nose, allowing patients to continue to eat, drink, and speak, which is difficult with mask-based forms of respiratory support. In addition, the softFlow 50 system provides warm, humidified gas into the patient’s nose, to enhance comfort and aid in mucous clearance. With its ability to precisely deliver high respiratory gas flow rates well above those required for typical respiratory demand, clinicians can also take advantage of the high-flow rate to help limit the entrainment of room air (which can reduce the quantity of delivered inhaled oxygen). The innovative integrated airflow generator of the softFlow technology and water reservoir attachment allow for continued HFNC treatment of recovering COVID-19 patients in the home and other care settings, without the need for a separate source for high-flow air like other devices. The device’s simple, intuitive interface allows patients or their caregivers (who can lock settings) to easily customize the flow rate and humidification level. First available in 2016, softFlow is now in use in numerous countries in Africa, Asia, and Europe. Beijing Aerospace Changfeng Co., LTD, of China, noted, “We are very satisfied with the therapy successes we achieve with this device. We would like to emphasize the stable flow during inhalation and exhalation, which is generated by the powerful motor, which doesn’t need an external air source, as well as the resulting CO2 washing out. This fact opens up possibilities for [use as] a therapy for hypercapnic patients. Another very positive aspect of the device is the way it prevents condensation in the applicator by warming the entire tube system up to the nasal cannula. … All in all we are very satisfied with the handling of the device and the medical results.” Miguel Marina Barrio, Product Manager, Intensive Care Division, Hospital Hispania, Spain, added, “We already ordered 50 devices and we are very satisfied with the way softFlow performed. … In our opinion, the following points are very good: menu structure, product features, design, usability, manuals, delivery times. … The product quality, customer service, and type of packaging are particularly excellent.” Dr Dalal Al Matrouk, Head of Anesthesia and ICU at Farwaniya Hospital, Ministry of Health, Kuwait, said, “We have deployed 10 units of Masimo softFlow to help our clinicians manage patients with COVID-19-induced respiratory problems. We realize that high-flow nasal therapy could potentially help avoid invasive mechanical ventilation and its associated risks of ventilator-induced lung injury and hospital-acquired pneumonia.” Joe Kiani, Founder and CEO of Masimo, said, “We believe softFlow provides clinicians with an important tool to help address the growing number of people with compromised respiratory function, whether in high-acuity or low-acuity settings, including at home. We’re happy to now be able to offer this technology in the United States.”

Lab-based antigen test available on high-throughput analyzers

FEB 23 2021

Siemens Healthineers announced the company's laboratory-based SARS-CoV-2 Antigen Assay (CoV2Ag) obtained CE Mark and is now offered for the Atellica Solution and ADVIA Centaur analyzers, widely available in laboratories worldwide. The test has been submitted to the FDA for Emergency Use Authorization. The antigen test detects the nucleocapsid antigen and has been designed with five monoclonal antibodies with the objective to maximize its sensitivity to both current and future SARS-CoV-2 variants. It also offers a leading time-to-result for lab-based antigen tests, making it an ideal tool to test large quantities of patient samples quickly. Additionally, the test helps protect laboratory staff from the virus with a pretreatment process, which inactivates the virus without compromising the quality or validity of patient test results. The Siemens Healthineers' CoV2Ag test shows strong alignment to molecular RT-PCR methods with sensitivity exceeding 94% and specificity at 100% for the Atellica COVAg test. While molecular RT-PCR diagnostic testing is the gold standard in accuracy, it lacks the high throughput capability of a lab-based, automated antigen test. With availability of CoV2Ag on the Atellica IM Analyzer, laboratories can significantly increase the SARS-CoV-2 testing capacity with a platform that can run up to 440 tests per hour. Other benefits of lab-based, automated antigen testing include simplified pre-analytics and a more economical cost per test compared with RT-PCR testing, making this a cost effective solution to detect infection when high throughput is critical. Such testing could be deployed at on-site collection centers for hospital staff, patients and visitors, remote collection facilities for large scale testing of local populations or in dedicated, pop-up labs at airports or large universities. "SARS-CoV-2 antigen testing is a critical tool to help support the fight against COVID-19 and identify infected individuals, including those who are asymptomatic," said Deepak Nath, PhD, President of Laboratory Diagnostics at Siemens Healthineers. "High-throughput SARS-CoV-2 antigen testing can help laboratories rapidly scale their SARS-CoV-2 diagnostic testing capacity. The Siemens Healthineers' antigen test offers fast pretreatment time and time to results." The CoV2Ag assay is for in vitro diagnostic use in the qualitative detection of SARS-CoV-2 in nasopharyngeal swab and nasal swab specimens within the first seven days of symptom onset, or from asymptomatic individuals, using the Atellica IM Analyzer or ADVIA Centaur XP and ADVIA Centaur XPT immunoassay Systems. Siemens Healthineers has distinguished itself as a provider of quality assays to aid the COVID-19 pandemic. In addition to antibody, antigen, and molecular SARS-CoV-2 tests, Siemens Healthineers offers a broad diagnostics portfolio to aid in the prognosis, treatment and follow-up of COVID-19 patients. The company’s broad and differentiated menu includes hematology, coagulation, cardiac, respiratory, inflammation and infectious disease panels. Blood gas and imaging solutions from Siemens Healthineers deliver actionable results that aid clinicians in caring for COVID-19 patients. This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA), under Contract No. 75A50121P00005.

Device Helps Make VAP Preventable

JAN 16 2021

The issue of secondary bacterial infection during a pandemic is nothing new. Per Dr. Fauci, “The majority of deaths in the 1918-1919 influenza (Spanish Flu) pandemic resulted directly from secondary bacterial pneumonia caused by common upper-respiratory-tract bacteria.” Today, half of the COVID problem is actually COVID. The other half is pneumonia or secondary bacterial infections which is preventable if hospitals use proper secretion management equipment. An estimated 150k+ COVID deaths involve VAP. VAP is preventable. The SIMEX device reduces VAP risk.
“Sadly, this is a very serious problem that is not going away and is getting worst and worst by the minute especially in California where the percentage of COVID ventilated patients dying due to VAP pneumonia is at 56% (10% higher than the national average),” said Hamid Khosrowshahi, President, FloSure Technologies’ LLC

Long-COVID Cases Rise as Stigma of Chronic Fatigue Taunts

JAN 16 2021

When Margot Gage-Witvliet began feeling run down after her family returned from a trip to the Netherlands in late February, she initially chalked up her symptoms to jet lag. Three days later, however, her situation went from concerning to alarming as she struggled to breathe. "It felt like there was an elephant sitting on my chest," she said. Her husband and daughters also became ill with COVID-19, but Gage-Witvliet was the only one in her family who didn't get better. After an early improvement, a rare coronavirus-induced tonic-clonic seizure in early April sent her spiraling back down. Gage-Witvliet spent the next several weeks in bed with the curtains drawn, unable to tolerate light or sound. Today, Gage-Witvliet's life looks nothing like it did 6 months ago when she first got sick. As one of COVID-19's so called long haulers, she continues to struggle with crushing fatigue, brain fog, and headaches — symptoms that worsen when she pushes herself to do more. Across the country, as many as one in 10 COVID-19 patients are reporting illnesses that continue for weeks and months after their initial diagnosis. Nearly all report neurologic issues like Gage-Witvliet, as well as shortness of breath and psychiatric concerns. For Avindra Nath, MD, a neurologist at the National Institutes of Health, the experience of these long-haul COVID-19 patients feels familiar and reminds him of myalgic encephalomyelitis, also known as chronic fatigue syndrome. Nath has long been interested in the lingering neurologic issues connected to chronic fatigue. An estimated three-quarters of all patients with chronic fatigue syndrome report that their symptoms started after a viral infection, and they suffer unrelenting exhaustion, difficulties regulating pulse and blood pressure, aches and pains, and brain fog. When Nath first read about the novel coronavirus, he began to worry that the virus would trigger symptoms in a subset of those infected. Hearing about the experiences of long-haulers like Gage-Witvliet raised his suspicions even more. Unlike COVID-19 long haulers, however, many patients with chronic fatigue syndrome go at least a year with these symptoms before receiving a diagnosis, according to a British survey. That means researchers have had few opportunities to study the early stages of the syndrome. "When we see patients with myalgic encephalomyelitis, whatever infection they might have had occurred in the remote past, so there's no way for us to know how they got infected with it, what the infection was, or what the effects of it were in that early phase. We're seeing them 2 years afterward," Nath said. Nath quickly realized that studying patients like Gage-Witvliet would give physicians and scientists a unique opportunity to understand not only long-term outcomes of COVID-19 infections, but also other postviral syndromes, including chronic fatigue syndrome at their earliest stages. It's why Nath has spent the past several months scrambling to launch two National Institutes of Health (NIH) studies to examine the phenomenon. Although Nath said that the parallels between COVID-19 long haulers and those with chronic fatigue syndrome are obvious, he cautions against assuming that they are the same phenomenon. Some long haulers might simply be taking a much slower path to recovery, or they might have a condition that looks similar on the surface but differs from chronic fatigue syndrome on a molecular level. But even if Nath fails to see links to chronic fatigue syndrome, with more than 92.5 million documented cases of COVID-19 around the world, the work will be relevant to the substantial number of infected individuals who don't recover quickly.

Microsoft, Cigna Form Coalition for Digital Records of COVID-19 Vaccination

JAN 16 2021

Tech giants including Microsoft Corp, Oracle Corp and healthcare companies Cigna Corp and Mayo Clinic are part of a coalition pushing for digital records of people who get vaccinated against COVID-19. The project, called Vaccination Credential Initiative, aims to help people get encrypted digital copies of their immunization records stored in a digital wallet of their choice, the companies said in a statement. Individuals without smartphones would receive paper printed with QR codes containing the credentials, they said. In the United States, where vaccines from Pfizer Inc and Moderna Inc have been authorized for emergency use, vaccinated individuals receive a vaccination card or printout. The current system does not readily support convenient access, control and sharing of verifiable vaccination records, the companies said.

Disinfecting During Pandemic Puts Asthmatics at Risk

JAN 16 2021

Increased cleaning by people with asthma during the pandemic may be triggering flares of their disease, a new report suggests. Researchers who surveyed 795 US adults with asthma between May and September found the proportion who disinfected surfaces with bleach at least five times a week rose by 155 percent after the pandemic started. Use of disinfectant wipes, sprays and other liquids also increased, the researchers reported in the Journal of Allergy & Clinical Immunology: In Practice. After accounting for other behaviors and risk factors, higher odds of having uncontrolled asthma were linked with greater household use of disinfectant wipes, disinfectant sprays, bleach and water solutions, and other disinfecting liquids. The study does not prove that increased frequency of disinfecting caused uncontrolled asthma. Still, the authors say, people with asthma need safer cleaning options. The Centers for Disease Control and Prevention advises asthmatics to ask someone else to clean and disinfect surfaces and to stay in another room when cleaners or disinfectants are used and right afterward. It also said soap and water may be sufficient for surfaces and objects that are seldom touched.

Pfizer to Complete Supply of COVID-19 Vaccines to EU by September

DEC 30 2020

The distribution of an initial 200 million doses of the COVID-19 vaccine developed by Pfizer and BioNTech across the European Union will be completed by September, a spokesman for the EU Commission said. The protracted timetable, which was previously unknown, confirms that the bloc, with a population of 450 million, will need vaccines from other suppliers to speed up inoculations against the coronavirus. Most EU countries began inoculating healthcare workers and vulnerable people on Sunday with the Pfizer vaccine, which is the only one so far authorised in the 27-nation bloc, and requires a two-dose regimen. "Distribution of the full 200 million doses is scheduled to be completed by September 2021," the spokesman said in an emailed statement. A spokesman for Pfizer declined to comment on specific schedules or whether the timeline indicated by the Commission represented a delay in planned supplies, adding: "Our timelines are aspirational and can shift based on capacity and manufacturing timelines. These considerations will in turn refine supply projections and delivery schedules". Talks are underway on delivery of a further 100 million doses which are optional under the contract sealed with the two companies, the EU spokesman said. The timetable for the additional doses is unclear. Pfizer's spokesman said the option for another 100 million doses had not been concluded. The EU spokesman said most supply contracts agreed by the EU with COVID-19 vaccine makers foresee the majority of deliveries completed by the end of next year. The EU has signed advance purchase agreements with Pfizer-BioNTech, AstraZeneca, Johnson & Johnson, Moderna, Sanofi and CureVac for a total of nearly 2 billion doses.

Complete Blood Count Scoring Can Predict COVID-19 Severity

DEC 30 2020

A scoring system based on 10 parameters in a complete blood count (CBC) with differential within 3 days of hospital presentation predict those with COVID-19 who are most likely to progress to critical illness, new evidence shows. Advantages include prognosis based on a common and inexpensive clinical measure, as well as automatic generation of the score along with CBC results, note investigators in the observational study conducted throughout 11 European hospitals. "COVID-19 comes along with specific alterations in circulating blood cells that can be detected by a routine hematology analyzer, especially when that hematology analyzer is also capable to recognize activated immune cells and early circulating blood cells, such as erythroblast and immature granulocytes," senior author Andre van der Ven, MD, PhD, infectious diseases specialist and professor of international health at Radboud University Medical Center's Center for Infectious Diseases in Nijmegen, the Netherlands, said. Furthermore, van der Ven said, "these specific changes are also seen in the early course of COVID-19 disease, and more in those that will develop serious disease compared to those with mild disease." The study was published online December 21 in the journal eLife. The study is "almost instinctively correct. It's basically what clinicians do informally with complete blood count…looking at a combination of results to get the gestalt of what patients are going through," Samuel Reichberg, MD, PhD, associate medical director of the Northwell Health Core Laboratory in Lake Success, New York, said. "This is something that begs to be done for COVID-19. I'm surprised no one has done this before," he added. Van der Ven and colleagues created an algorithm based on 1587 CBC assays from 923 adults. They also validated the scoring system in a second cohort of 217 CBC measurements in 202 people. The findings were concordant — the score accurately predicted the need for critical care within 14 days in 70.5% of the development cohort and 72% of the validation group. The scoring system was superior to any of the 10 parameters alone. Over 14 days, the majority of those classified as noncritical (NC) within the first 3 days remained clinically stable, whereas the "clinical illness" (CI) group progressed. Clinical severity peaked on day 6. Most previous COVID-19 prognosis research was geographically limited, carried a high risk for bias and/or did not validate the findings, Van der Ven and colleagues note.

Vitamin D Fails to Help in Severe COVID-19

DEC 30 2020

Vitamin D has gained immense popularity amid the coronavirus disease 2019 (COVID-19) pandemic. Several studies have tied vitamin D deficiency to the severity of COVID-19. Health experts are investigating if taking vitamin D may help protect against severe COVID-19. A team of researchers at the University of São Paulo in Brazil aimed to determine if vitamin D3 supplementation reduces length of stay in hospitalized patients with severe COVID-19. The researchers found that taking vitamin D3 was safe and effective in increasing 25-hydroxyvitamin D levels but did not reduce hospital length of stay or yield any other clinically-relevant outcomes compared with a placebo. In the current study, which appeared on the preprint server medRxiv, the team wanted to determine if vitamin D supplementation can reduce the hospital length of stay and improve clinical outcomes in hospitalized COVID-19 patients. The team conducted a multicenter, double-blind, randomized and placebo-controlled trial in two centers in Sao Paulo, Brazil. The trial included 240 hospitalized patients with severe COVID-19. The team randomly assigned patients to receive either a single oral dose of 200,000 IU of vitamin D3 or a placebo. The team wanted to determine the effects of vitamin D3 supplementation on the hospital length of stay, defined as hospital discharge or death. Other recognized outcomes were mortality, mechanical ventilation requirement, admission to the intensive care unit (ICU) and serum levels of 250-hydroxyvitamin D, calcium, creatinine, D-dimer and C-reactive protein. The team has found that of the 240 randomized patients, vitamin D supplementation markedly increased serum 25-hydroxyvitamin D levels compared to placebo. The supplement increased the serum vitamin D levels in 86.7 percent of the patients, compared to 11 percent in the placebo group. "There were no changes in any health-related laboratory markers following the intervention. Vitamin D3 supplementation was well tolerated, and no severe adverse events were reported throughout the trial," the researchers noted. However, vitamin D3 supplementation is ineffective in improving hospital length of stay or any other clinical outcomes among hospitalized patients with severe COVID-19. The single dose of 200,000 IU of vitamin D3 supplementation could not promote any clinically relevant effects among the study participants. "Thus, this trial does not support the use of vitamin D3 supplementation as an adjuvant treatment of patients with COVID-19," the team concluded.

Patients With Lung and Blood Cancers Most Vulnerable to COVID-19

DEC 30 2020

Patients with cancer are at significantly increased risk for COVID-19 and worse outcomes, a new review confirms. It also found that patients with leukemia, non-Hodgkin lymphoma, and lung cancer are at greatest risk. Black patients with cancer are at even higher risk, and for patients with colorectal cancer and non-Hodgkin lymphoma, the risk is higher for women than for men. (This contrasts with findings in noncancer populations, where men are more at risk from COVID and severe outcomes than women). These findings come from a huge review of electronic health records of 73.4 million patients in the United States. They "highlight the need to protect and monitor patients with cancer as part of the strategy to control the pandemic," say the authors. The review was published online December 10 in JAMA Oncology. The greater risk for COVID-19 among patients with cancer is well known, but breaking the risk down by cancer type is novel, say the investigators, led by Quanqiu Wang, MS, Center for Artificial Intelligence in Drug Discovery, Case Western Reserve University, Cleveland, Ohio. Cancer patients are immunocompromised and have more contact with the healthcare system, which increases their risk for COVID-19. But which bodily systems are affected by cancer seems to matter. In patients with blood cancer, for example, COVID is probably more dangerous, because blood cancer weakens the immune system directly, the authors suggest. The increased risk for infection and hospitalization with SARS-CoV-2 among Black patients with cancer might be due to biology, but it is more likely due to factors that weren't captured in the database review. Such factors include social adversity, economic status, access to healthcare, and lifestyle, the researchers comment. For this study, the investigators analyzed electronic health records held in the in the IBM Watson Health Explorys system, which captures about 15% of new cancer diagnoses in the United States. The analysis found that as of August 14, 2020, 16,570 patients (0.02%) had been diagnosed with COVID-19; about 1200 also had been diagnosed with cancer. Of those, 690 were diagnosed with cancer in the previous year, which counted as a recent cancer diagnosis in the analysis. The study included 13 common cancers, including endometrial, kidney, liver, lung, gastrointestinal, prostate, skin, and thyroid cancers, among others. Patients with any cancer diagnosis (adjusted odds ratio [aOR], 1.46) as well as those with a recent cancer diagnosis (aOR, 7.14) had a significantly higher risk for COVID-19 than those without cancer, after adjusting for asthma, cardiovascular diseases, nursing home stays, and other risk factors.

Zenith Award Handed Out


In a year which will be heralded as one of the toughest that healthcare has had to endure, with the COVID-19 pandemic pulling on all hospital and clinician resources, the role of companies supporting these healthcare workers and their patients has become critical. Aerogen, the global leader in aerosol drug delivery, has been selected by over 47,000 respiratory clinicians to receive the prestigious 2020 Zenith Award from the American Association of Respiratory Care. This year marks the seventh time that Aerogen has been selected as a recipient of the Zenith Award. The award, which is in its 32 nd year, represents a means for respiratory care professionals to recognize excellence from companies and service suppliers to the hospital. The award spans a wide range of criteria including equipment and supplies, the accessibility and helpfulness of their sales personnel, responsiveness, service record, truth in advertising, and their support of the respiratory care profession. “Aerogen exemplifies the qualities represented in the criteria and, because of this; we salute [Aerogen] and [its] employees”, said Thomas J Kallstrom, MBA, RRT, FAARC, Executive Director/CEO. Adding to this sentiment John Power, CEO of Aerogen said, “We are honored to be recognized by the respiratory therapy community in this way. As a seventh time recipient, we are proud to retain the confidence and trust of respiratory care professionals especially during this difficult year. Our purpose has always been to make a meaningful difference to those most critically in need of care and we do everything we can to ensure this is achieved daily.” Aerogen will receive this award at AARC’s 66th International Respiratory Congress this November during a virtual ceremony. More information at

Free Spirometry Training Offered


NDD Medical Technologies is the leading provider of pulmonary function equipment, dedicated to the early detection and accurate diagnosis of COPD and other chronic lung diseases. In line with its continued commitment to supporting respiratory professionals — particularly in the wake of the COVID-19 pandemic—NDD is now offering free, live spirometry training sessions to provide professionals with renewed confidence in lung function testing for the most accurate results. The EasyOne product line was developed for health care providers to offer accurate and reliable diagnosis at the point of care and start immediate treatment. This helps avoid irreversible lung damage for millions of patients while significantly reducing healthcare costs. NDD is now offering live training webinars that will detail how to perform spirometry with the highly reliable and accurate EasyOne Air and Easy-on PC spirometers. The webinars begin 29th September 2020; those interested can register at Spirometry testing is dependent on patient effort, and proper coaching and a good understanding of technique are therefore vital. Staff turnover and delays caused by the COVID-19 pandemic are some of the many reasons NDD has decided to offer free refresher training courses focusing on best practices in obtaining good quality spirometry results. NDD’s lung function testing products are used globally by leading pulmonologists and medical researchers due to the product line’s portability and accuracy. NDD has always invested in pulmonary function education for its customers, and this new program of live spirometry training webinars will expand to include the diffusing capacity for carbon monoxide (DLCO) and multiple breath nitrogen washout (MBW) tests. This is another example of NDD’s commitment to ensuring that all users get the most accurate results when performing pulmonary function testing. Jessica Dietrich, RRT, US Training Manager at NDD commented, “NDD has a long-standing commitment to providing the best devices, continued support, and education to the healthcare community. In a COVID-19 world, where facilities are now beginning to start testing again, we are offering important refresher training to help offices achieve the best quality results as they get back on their feet.” Webinars will be recorded and available to view after the live events. NDD’s revolutionary EasyOne portfolio includes the EasyOne Air, Easy on-PC, EasyOne Pro, and EasyOne Pro LAB. EasyOne products are among the most accurate devices available and deliver reliable, real-time lung function results at the point of care—enabling early diagnosis of chronic lung diseases such as COPD. For more information about NDD’s lung function testing products, visit

Patients Survive Ventilator, But Linger in a Coma


Leslie Cutitta said yes, twice, when clinicians from Massachusetts General Hospital in Boston called asking whether she wanted them to take — and then continue — extreme measures to keep her husband, Frank Cutitta, alive. The first conversation, in late March, was about whether to let Frank go or to try some experimental drugs and treatments for COVID-19. The second call was just a few days later. Hospital visits were banned, so Leslie couldn't be with her husband or discuss his wishes with the medical team in person. So she used stories to try to describe Frank's zest for life. "Frank used to joke that he wanted to be frozen, like Ted Williams, until they could figure out what was wrong with him if he died," said Leslie Cutitta. It wasn't a serious end-of-life discussion, but Cutitta knew her husband would want every possible lifesaving measure deployed. So the Cutittas hung on and a small army of ICU caregivers kept working. On April 21, after 27 days on a ventilator, Frank's lungs had recovered enough to remove the breathing tube. After the removal, it typically takes hours, maybe a day, for the patient to return to consciousness. The body needs that time to clear the drugs that keep the patient sedated and comfortable — able to tolerate intubation and mechanical ventilation. But doctors across the US and in other countries have noted a troubling phenomenon associated with some COVID cases: Even after extubation, some patients remain unconscious for days, weeks, or longer. There's no official term for the problem, but it's being called a "prolonged" or "persistent" coma or unresponsiveness. Frank Cutitta, 68, was one of those patients. He just didn't wake up. "It was a long, difficult period of not — just not knowing whether he was going to come back to the Frank we knew and loved," said Leslie Cutitta. "It was very, very tough." Doctors studying the phenomenon of prolonged unresponsiveness are concerned that medical teams are not waiting long enough for these COVID-19 patients to wake up, especially when ICU beds are in high demand during the pandemic. As Frank's unresponsive condition continued, it prompted a new conversation between the medical team and his wife about whether to continue life support. Although he no longer needed the ventilator, he still required a feeding tube, intravenous fluids, catheters for bodily waste, and some oxygen support. Leslie Cutitta recalled a doctor asking her: "If it looks like Frank's not going to return mentally, and he's going to be hooked up to a dialysis machine for the rest of his life in a long-term care facility, is that something that you and he could live with?" She struggled to imagine the restricted life Frank might face. Every day, sometimes several times a day, she would ask Frank's doctors for more information: What's going on inside his brain? Why is this happening? When might something change?

Statins Linked to Reduced Mortality in COVID-19


Treatment with statins was associated with a reduced risk of a severe or fatal course of COVID-19 by 30%, a meta-analysis of four published studies has shown. In the analysis that included almost 9000 COVID-19 patients, there was a significantly reduced risk for fatal or severe COVID-19 among patients who were users of statins compared with non-users (pooled hazard ratio [HR], 0.70; 95% CI, 0.53 - 0.94). Based on the findings, "it may be time we shift our focus to statins as the potential therapeutic options in COVID-19 patients," authors Syed Shahzad Hasan, PhD, University of Huddersfield, UK, and Chia Siang Kow, MPharm, International Medical University, Kuala Lumpur, Malaysia, wrote in a joint emailed comment. The study was published online August 11 in The American Journal of Cardiology. The analysis included four studies published up to July 27 of this year. Eligible studies included those with a cohort or case-control designs, enrolled patients with confirmed COVID-19, and had data available allowing comparison of the risk of severe illness and/or mortality among statin users vs non-users in adjusted analyses, the authors note. The four studies — one of "moderate" quality and three of "good" quality — included a total of 8990 COVID-19 patients. In the pooled analysis, there was a significantly reduced risk for fatal or severe COVID-19 with use of statins compared to non-use of statins (pooled HR, 0.70; 95% CI, 0.53 - 0.94). Their findings also "discredited the suggestion of harms with the use of statins in COVID-19 patients," the authors conclude. "Since our meta-analysis included a fairly large total number of COVID-19 patients from four studies in which three are large-scale studies that adjusted extensively for multiple potential confounding factors, the findings can be considered reliable," Hasan and Kow write in their article. Based on the results, "moderate-to-high intensity statin therapy is likely to be beneficial" in patients with COVID-19, they said. However, they caution that more data from prospective studies are needed to substantiate the findings and to determine the appropriate regimen for a statin in COVID-19 patients. Reached for comment, Yibin Wang, PhD, of the David Geffen School of Medicine, University of California, Los Angeles, said, "This is a very simple meta-analysis from four published studies which consistently reported a protective or neutral effect of statin usage on mortality or severe complications in COVID-19 patients."

Texas, Florida, California, New York Will Not Follow New US COVID-19 Testing Plan


Several large US states including Texas are not heeding new federal health officials' calls to reduce COVID-19 testing of some exposed to the virus, joining a broad rebuke of the Trump administration by public health leaders. California, Connecticut, Florida, Illinois, Texas, New Jersey and New York all plan to continue to test asymptomatic people who have been exposed to COVID-19, despite new guidance from the Centers for Disease Control and Prevention (CDC) suggesting that such tests may not be needed. "The current Texas guidance recommends testing for all close contacts of a confirmed case because it allows for early case identification among people who are at a higher risk of infection," a spokesman for the Texas Department of State Health Services in a statement. "There's not a planned change at this point." California and New York made similar statements. The Florida Department of Health said asymptomatic testing was continuing while the new CDC recommendations were evaluated, and Texas also said it would evaluate. The CDC said this week that people exposed to COVID-19 but not symptomatic may not need to be tested, shocking doctors and politicians and prompting accusations the guidance was politically motivated. Even before the CDC guidance, coronavirus testing in the United States had dropped. The United States tested on average 675,000 people a day last week, down from a peak in late July of over 800,000 people a day. Nationally, cases have fallen for five weeks in a row but infections are surging again in the U.S. Midwest with four states reporting record one-day increases in cases on Thursday as the U.S. death toll climbed above 180,000. The CDC had previously recommended testing of all people who had close contact with someone who was diagnosed with COVID-19. New York Governor Andrew Cuomo said the state of New York would not be abiding by the new guidance and challenged the assertion that politics played no role in the change. "This 180-degree reversal of COVID-19 testing guidelines is reckless, and not based on science and has the potential to do long-term damage to the (CDC's) reputation," Cuomo said in a joint statement, along with the governors of New Jersey and Connecticut, who also said their states would not be following the CDC's guidance. Admiral Brett Giroir, the assistant secretary for health at the Department of Health and Human Services (HHS), said there was no political pressure from the administration. He said that testing asymptomatic patients too early could produce false negatives and contribute to the virus's spread. CNN and The New York Times reported that US public health officials were ordered by high-level members of the Trump administration to push forward with the changes. CDC Director Robert Redfield issued a statement on Thursday that "everyone who needs a COVID-19 test, can get a test," but "everyone who wants a test does not necessarily need a test." Globally, many nations advocate early testing. The World Health Organization (WHO) on Thursday said that resources permitting, people exposed to the novel coronavirus should be tested even if they do not show immediate symptoms of infection. European governments have used broad testing and isolation to control the virus. France, for instance, recommends that anyone who thinks they need a test should get one and in Germany, people with close contact of 15 minutes or more with a person with COVID-19 are advised to have a test.

Large Study Links Asthma, Allergic Rhinitis to Severe COVID-19


People with allergic rhinitis and asthma may be slightly more prone to contracting COVID-19 and considerably more to developing severe disease when infected, according to a nationwide cohort study from South Korea. The risk was especially high for individuals with non-allergic asthma, who were more than four times as likely to have severe COVID-19 as those without asthma, Dr Jee Myung Yang of the University of Ulsan College of Medicine, in Seoul, and colleagues found. The team says their study provides strong evidence of a link between respiratory allergic diseases and the risk of contracting COVID-19 and/or having worse clinical outcomes of the infection. Studies of COVID-19 and asthma to date have had mixed results, and small sample sizes, the authors note in the Journal of Allergy and Clinical Immunology. They looked at data from South Korea's Health Insurance Review and Assessment Service for more than 219,000 adults who underwent COVID testing between January 1 and May 15, including 14.9% diagnosed with asthma, 63.1% with allergic rhinitis and 3.9% with atopic dermatitis. A total of 7,340 tested positive for SARS-CoV-2, including 725 with asthma (9.9%), 4,210 with allergic rhinitis (57.4%) and 136 with atopic dermatitis (1.9%). The rate of SARS-CoV-2 positivity was 2.3% for people with asthma and 2.2% for those without asthma (adjusted odds ratio 1.08; 95% confidence interval, 1.01 to 1.17) and 3.3% and 2.8% for those with and without allergic rhinitis, respectively (aOR, 1.18; 95% CI, 1.11 to 1.25). The increase was greater for those with non-allergic asthma (aOR, 1.34; 95% CI, 1.07 to 1.71) than those with allergic asthma (aOR, 1.06; 95% CI, 0.97 to 1.17). Severe clinical outcomes occurred in 6.9% of patients with asthma and 4.5% of those without (aOR, 1.62; 95% CI, 1.01 to 2.67), and in 4.7% of patients with allergic rhinitis and 3.7% of those with no allergic rhinitis (aOR, 1.27; 95% CI, 1.00 to 1.64). The odds of developing severe COVID-19 was more than quadrupled for patients with non-allergic asthma (aOR, 4.09; 95% CI, 1.69 to 10.52), while the risk increase was less pronounced for those with allergic asthma (aOR, 1.40; 95% CI, 0.83 to 2.41).

Workstation Deployed


Yale New Haven Health System (YNHHS), the largest health system in Connecticut, has deployed Capsule’s Ventilated Patient Surveillance (VPS) workstation to deliver safe and effective patient care to its COVID-19 ventilated patients, both organizations announced. With the onset of the coronavirus pandemic and the upsurge in patients requiring acute respiratory care, YNHHS reached out to Capsule for a technology solution. Together the organizations devised the Ventilated Patient Surveillance workstation, based on Capsule’s existing Remote Surveillance application. Launched at YNHHS, the Capsule VPS workstation analyzes streaming live data from ventilators, which are not ordinarily connected for surveillance, and escalates emergent clinically actionable events to respiratory therapists, pulmonologists and intensivists. The added surveillance capability complements the health system’s established InSight Tele-ICU program, which has employed Capsule’s Remote Surveillance solution for many years. “While developing the VPS workstation, we expected it to provide caregivers additional eyes on their patients for delivering timely interventions,” said Hemant Goel, chief executive officer of Capsule Technologies. “We realized, soon after deploying these at Yale, that the VPS workstation delivered additional benefits, such as protecting caregivers from unnecessary exposure to infection and reducing the use of personal protective equipment (PPE). Yale New Haven is among the first hospitals to deploy the solution, maintaining a high standard of care for today’s coronavirus patients, while establishing a higher standard through extended device connectivity.” Due to the risk of infection, YNHHS patient room doors remain closed, and entering and exiting patient areas takes more time than usual for donning and doffing PPE. With a limited number of Respiratory Therapists (RTs) to cover all ventilators, the VPS workstation helps staff determine a clinically advantageous time to go into patient areas and provide care. It also enables RTs outside the room to guide less experienced care team members at the bedside. YNHHS has transformed many non-ICU patient rooms into temporary ICU rooms, creating negative pressure environments to mitigate infection spread. Many of these rooms are isolated and do not have windows into accessways, so ventilators and bedside medical devices are not visible, and alarms are not easily heard. The VPS workstation helps staff remotely see and hear the ventilators in these non-traditional ICU settings. The system’s smart rules highlight clinically actionable emergent events, enabling care providers to formulate an effective response. Overall, YNHHS believes that they are achieving superior patient outcomes for COVID-19 ventilated patients compared to most other reported data from hospitals in the US “Our collaboration with Capsule Technologies is an extension of our existing partnership and our own long-held vision for using technology to manage critically ill patients through remote access, analytics and smart notifications,” said Chris Gutmann, system director, Information Technology and Clinical Engineering at YNHHS. “This ventilated patient surveillance solution is not only helping our care teams confront the COVID-19 pandemic today, but I expect it will continue to serve the needs of our clinicians and patients well into the future, becoming a standard of care.” Ventilated patient surveillance leverages the ventilator connectivity of the Capsule Medical Device Information Platform, used in more than 2,000 US hospitals. Capsule is offering the VPS workstation to its customers in the US, where Capsule Surveillance has FDA clearance. To reduce the financial burden on hospitals, the company provides all necessary software licenses for the VPS workstation at no charge to all eligible clients for an initial period of at least six months and potentially longer if the pandemic persists. For more information about ventilated patient surveillance, visit, or contact Capsule Technologies at 1-800-260-9531

Lung Simulators Produced to Fill Shortage.


Michigan Instruments, a leading manufacturer in Lung Simulation, has delivered an unprecedented number of lung simulators to organizations around the world to help in respiratory technology research and critical ventilator development and manufacturing to combat the shortages caused by the COVID-19 pandemic. Many countries, including the United States, are continuing to see a rise in COVID-19 cases, which brings to light the extreme lack of medical resources like ventilators available to hospitals and critical care facilities. In response, the world has seen an incredible response in the development and manufacturing of ventilators as researchers attempt to create a cost-effective and efficient lifesaving solution. Michigan Instruments has been at the forefront of this response by working with organizations to deliver Lung Simulators designed for validating and testing these ventilators. Organizations like NASA, Ford Motor Company, Cornell University, Michigan Technological University, University of California San Diego, OperationAir, and the Royal Women’s Hospital, Monash University and the Alfred Hospital in Australia have all used Michigan Instruments lung simulators to aid in the development and discovery of several potential ventilator solutions. A group of engineers from NASA’s Jet Propulsion Laboratory have developed a high-pressure ventilator that can mechanically breathe for patients with the most severe cases of COVID-19. Students and faculty from Cornell University, Michigan Technological University, and the University of California San Diego have all developed versions of effective, low-cost ventilator systems created using inexpensive materials or materials readily available. OperationAir has also developed a prototype called the AIRone, an easily producible emergency ventilator that can be used when shortages occur due to the pandemic. Production has already started on the device and its design is open source and available globally. A team of researchers from the Royal Women’s Hospital, Monash University, and Alfred Hospital have successfully tested, in a simulated environment, the potential to ventilate two lungs of different compliances from a single ventilator using only commonly available hospital equipment. These lung simulators provide developers with cutting edge technology that can aid in the design, engineering, testing and manufacturing of devices like ventilators by replicating hundreds of healthy and diseased lung conditions to evaluate a ventilator’s performance with accurate measurement and data reporting.

Risk of Secondary COVID-19 Transmission Low in Most Settings


The risk of secondary transmission is less than 4% overall among close contacts of people diagnosed with COVID-19 and varies by settings and disease severity, new research shows. Lei Luo, PhD, with the Guangzhou Center for Disease Control and Prevention, China, and colleagues used contract tracing to test 3410 close contacts of 391 COVID-19 index cases between January and March in Guangzhou. Researchers identified cases through surveillance testing, screening symptomatic patients who presented to a healthcare facility, or tracing and screening people in close contact with those diagnosed with COVID-19. Among the close contacts, 127 (3.7%) became infected. Of those 127, eight (6.3%) were asymptomatic. Of the 119 symptomatic cases, 20 (16.8%) were mild, 87 (73.1%) were moderate, and 12 (10.1%) were severe or critical. The findings were published online August 13 in the Annals of Internal Medicine. To learn how risk varied by contact locations, they stratified contacts according to where they interacted with the index patient, including household, public transportation, health care settings, entertainment venues or workplaces, and multiple settings. Risks for secondary infection were highest for household contacts, at 10.3% (95% CI, 8.5% - 12.2%), followed by those exposed in health care settings, at 1.0% (95% CI, 0.3% - 1.8%; odds ratio [OR] relative to household exposure, 0.09), and on public transportation, at 0.1% (95% CI, 0.0% - 0.4%; OR, 0.01). The authors note that the 10.3% household transmission rate was consistent with previously reported secondary infection rates among household members of 11.2% in other cities in China and 10.5% in the United States.

Dilated Blood Vessels in the Lung May Explain Low Oxygen Levels in Severe Cases of COVID-19


A new pilot study from the Icahn School of Medicine at Mount Sinai suggests that COVID-19 is causing significant dilation of the blood vessels of the lung, specifically the capillaries. This vasodilation is contributing to the very low oxygen levels seen in COVID-19 respiratory failure and also helps explain why the disease behaves differently than classic acute respiratory distress syndrome (ARDS). The study was published in the American Journal of Respiratory and Critical Care Medicine. In classical ARDS, pulmonary inflammation leads to leaky pulmonary blood vessels that flood the lungs with fluid, making the lungs stiff and impairing oxygenation. Many patients with COVID-19 pneumonia demonstrate severe hypoxemia that is markedly out of proportion to the degree of lung stiffness. This disconnect between gas exchange and lung mechanics in COVID-19 pneumonia has raised the question of whether the mechanisms of hypoxemia in COVID-19 differ from those in classical ARDS. The discovery was serendipitous. Researchers were initially assessing cerebral blood flow in mechanically ventilated COVID-19 patients with altered mental status to look for, among other things, abnormalities consistent with stroke. They used a robotic transcranial Doppler (TCD), the Lucid Robotic System by NovaSignal, to perform a “bubble study,” which is a non-invasive and painless ultrasound technique. “It is remarkable that a diagnostic machine used to study the brain could give us insight into the pathophysiology of a pulmonary disease. The benefit of using this particular system was that automated monitoring allowed providers to assess cerebral blood flow while minimizing the potential for exposure to COVID-19,” said Alexandra Reynolds, MD, Assistant Professor of Neurosurgery, and Neurology, at the Icahn School of Medicine at Mount Sinai and Director of TeleNeurocritical Care for the Mount Sinai Health System. During this study, agitated saline—saline with tiny microbubbles—is injected into the patient’s vein and TCD is used to determine if those microbubbles appear in the blood vessels of the brain. Under normal circumstances, these microbubbles would travel to the right side of the heart, enter the blood vessels of the lungs, and ultimately get filtered by the pulmonary capillaries, because the diameter of the microbubbles is bigger than the diameter of the pulmonary capillaries. If the microbubbles are detected in the blood vessels of the brain, it implies that either there is a hole in the heart, so that blood can travel from the right to the left side of the heart without going through the lungs, or that the capillaries in the lungs are abnormally dilated, allowing the microbubbles to pass through. In the pilot study, 18 mechanically ventilated patients with severe COVID-19 pneumonia underwent TCD with bubble study. Fifteen out of the 18 (83 percent) patients had detectable microbubbles, indicating the presence of abnormally dilated pulmonary blood vessels. The number of microbubbles detected by the TCD correlated with the severity of hypoxemia, indicating that the pulmonary vasodilations may explain the disproportionate hypoxemia seen in many patients with COVID-19 pneumonia. Previous studies have demonstrated that only 26 percent of patients with classical ARDS have microbubbles during a bubble study; furthermore, the number of these microbubbles does not correlate with the severity of hypoxemia, implying that pulmonary vascular dilations are not a major mechanism of hypoxemia in classical ARDS. “It is becoming more evident that the virus wreaks havoc on the pulmonary vasculature in a variety of ways. If these findings are confirmed in larger studies, pulmonary microbubble transit may potentially serve as a marker of disease severity or even a surrogate endpoint in therapeutic trials for COVID-19 pneumonia. Future studies that investigate the use of pulmonary vascular constrictors in this patient population may be warranted,” says senior author Hooman Poor, MD, Assistant Professor of Medicine (Pulmonary, Critical Care and Sleep Medicine) at the Icahn School of Medicine at Mount Sinai and Director of Pulmonary Vascular Disease at the Mount Sinai – National Jewish Health Respiratory Institute. The pilot study has since expanded to collect data from approximately 80 patients, including those with less severe disease, and will evaluate the severity of microbubble transit and how it varies during the course of the disease.

Siemens Healthineers Obtains First FDA EUA for Semi-Quantitative Antibody Test


Siemens Healthineers announced that it received FDA Emergency Use Authorization (EUA) for the SARS-CoV-2 IgG (COV2G) antibody test. This is the first antibody test authorized with a semi-quantitative detection claim and the fifth antibody test from the company to receive EUA that offers sensitivity and specificity of greater than 99 percent. The COV2G antibody test offers both a positive or negative result for IgG antibodies and reports a numerical result expressed as index value. The test also attained the CE-mark and is now broadly available globally. A positive or negative result for IgG antibodies provides insight into an individual’s prior exposure to the SARS-CoV-2 virus. Importantly, a semi-quantitative result enables clinicians to gauge the level of IgG antibodies in a patient’s blood sample. With this numerical value, clinicians can establish a baseline and be better equipped to assess changes of an individual’s immune response to the SARS-CoV-2 virus. Comparison of numerical results will help determine how SARS-CoV-2 antibodies develop in an individual and persist over time. A semi-quantitative result is necessary to accurately establish the level of IgG that may be protective, and the Siemens Healthineers’ COV2G assay is well positioned to support this global pursuit. When an individual is infected with the SARS-CoV-2 virus, unique antibodies will develop at different stages of the infection. Whereas the Siemens Healthineers SARS-CoV-2 Total antibody test detects antibodies to IgM and IgG that are present both early and later during the immune response, the COV2G antibody test specifically detects IgG antibodies that persist, and are the basis for an individual’s longer term immune response. The combination of these tests provides a complete picture of a patient’s serological status for the most accurate results throughout his or her contiuum of care. “Our high-quality antibody test helps clinicians assess the level of a person‘s immune response, which is an important tool to have at this stage of the pandemic,” said Deepak Nath, PhD, President of Laboratory Diagnostics for Siemens Healthineers. “Siemens Healthineers offers a robust portfolio of reliable tests to help support patient care and fight COVID-19.” Highly accurate antibody test results support key decision-making for individuals and communities. Antibody tests have multiple uses: As an adjunct to PCR tests to aid in clinical assessment; to help determine prior exposure to the virus, by detecting antibodies that may neutralize the virus; to potentially identify donors of convalescent plasma; for epidemiological purposes including establishing prevalence of disease in populations; to potentially help verify effectiveness of vaccines as they become available. Antibody tests from Siemens Healthineers are well-positioned to aid vaccine development efforts. The COV2G antibody test, and all SARS-CoV-2 antibody tests from Siemens Healthineers, detect antibodies to S1RBD. Multiple potential vaccines in development for SARS-CoV-2 include the spike protein, specifically S1RBD—a key protein on the surface of the SARS-CoV-2 virus—within their focus. Among the considerations for accelerated vaccine approval, according to most recent FDA guidance issued on June 30, validated serology testing in clinical trials may play a pivotal role in assessing surrogate endpoints such as immune response to a vaccine. This requires additional understanding of SARS-CoV-2 immunology and, specifically, vaccine immune responses that might be reasonably likely to predict protection against COVID-19 and post-marketing studies to affirm predicted efficacy. The COV2G test meets or exceeds FDA EUA requirements. The COV2G antibody test is available on an expansive installed base of analyzers installed in the U.S. and in countries that accept the CE mark worldwide. This includes the Atellica Solution and ADVIA Centaur XP and XPT families of analyzers. Comparable tests for Siemens Healthineers Dimension Vista and Dimension EXL systems also are being pursued. Siemens Healthineers has distinguished itself during the pandemic as a provider of quality antibody tests. For example, in a recent head-to-head evaluation of four commercial antibody tests conducted by Public Health England, in partnership with the University of Oxford, Siemens Healthineers’ COV2T assay was the only test that met both sensitivity and specificity targets. To learn more about antibody test offerings from Siemens Healthineers, visit

Is Asthma a Risk Factor for Severe SARS-CoV-2 Pneumonia?


Patients with asthma appear not to have an elevated risk for severe SARS-CoV-2 pneumonia, nor does such pneumonia seem to induce severe asthma exacerbation, according to researchers in France. Asthma is listed as a risk factor for severe COVID-19 illness by the US Centers for Disease Control and Prevention, and other respiratory viral infections are known to be associated with severe asthma exacerbation. A recent study also found COVID-19 patients with asthma had prolonged intubation times. However, early case series have not shown an association between asthma and COVID-19. "Our results demonstrate that asthmatic patients do not experience differences in clinical symptoms or biological and radiological status in SARS-CoV-2 pneumonia," Dr Frederic de Blay of Strasbourg University Hospital and colleagues write in The Journal of Allergy and Clinical Immunology: In Practice. The team reviewed data from a dedicated COVID-19 unit at their hospital, which is also a referral center for asthma patients. In all, 106 patients with SARS-CoV-2 pneumonia were hospitalized there between March 4 and April 6, of whom 23 had asthma. Pneumonia was diagnosed on the basis of clinical symptoms, chest CT scan and laboratory confirmation of SARS-CoV-2 infection. About half (52.2%) of the patients with asthma were categorized as Gina 1 and were not receiving inhaled corticosteroids; 39.1% were classed as Gina 4 and 5. Nearly 20% of patients required admission to the intensive-care unit (ICU) and mechanical ventilation, but the risk of these outcomes did not differ between patients with or without asthma. Nor did asthmatic patients stay longer at the hospital, and none of them died. "Larger studies would be desirable to confirm our results and understand the mechanisms explaining such findings," the researchers write.

Patients With Pulmonary Disease Shouldn't Quit Aerosolized Medication Over COVID Fears


COVID-19 concerns should not stop patients from using inhaled corticosteroids, a new commentary article suggests. While patients with pulmonary diseases are at increased risk of developing COVID-19, those treatments may actually reduce the likelihood of infection and the worsening of symptoms in those already infected with the virus, a respiratory specialist advises in The Lancet Respiratory Medicine. "Patients with pulmonary disease should continue their regular treatment plan and continue taking their prescribed medications at home," said the author of the commentary, Azuri Ari, a professor in the department of respiratory care at Texas State University, in Round Rock. "Clinicians have been concerned about the use of steroids during the pandemic and patients specifically have been afraid of inhaled medications as a potential source of virus transmission and immunosuppression." In fact, Ari said, a recent study noted that SARS-CoV-19 infection rates appear to be lower in this population than with other chronic illnesses, and that might be because the medications are protective. Ari suggested precautions that could help stem the spread of the disease among housemates and family members. First, that clinicians prescribe inhalers over nebulizers whenever possible. "Exhaled air dispersion and virus transmission with inhalers are less than with jet nebulizers because inhalers have lower emitted doses and generate less aerosol mass," she writes in the commentary. "When the drug formulation is unavailable as an inhaler or patients cannot do the breathing techniques with inhalers, aerosols can be delivered with nebulizers." The type of device used by most patients is the jet nebulizer, Ari said. "Previous research shows that two-thirds of the aerosols that jet nebulizers generate are released into the environment, which might increase the risk of infection for family members and other caregivers," she said, adding that a mesh nebulizer might be a better choice since fewer aerosols are released into the environment with this this type of device. Either way, the best way to protect caregivers, family members and housemates is to nebulize away from others, Ari said. "When a patient needs to take inhaled medications it should be done on the porch or patio or in their garage," Ari said. "That way emissions won't circulate and accumulate in the house." If that's not possible, then the patient should isolate themselves during treatment in a room away from everyone else, Ari said. The room should be well-ventilated with open windows and a meter away from family members, she added. "Patients should cover their noses and mouths with a tissue when coughing and should discard the used tissue in a trash can in the patient's room," Ari cautioned.

Platform Expanded by Company


Masimo Corporation announced a significant expansion to the Masimo SafetyNet platform with the introduction of Radius Tº, a wearable, wireless sensor that provides continuous body temperature measurements. By augmenting the already powerful Masimo SafetyNet, which features Radius PPG tetherless pulse oximetry, with Radius Tº, the remote patient management solution becomes capable of tracking four key vital signs – oxygen saturation, respiration rate, pulse rate, and now temperature – making it an ideal solution for assessing the status of patients with suspected or low-acuity COVID-19, among many other remote patient management uses. Unlike spot-check thermometry solutions, Radius Tº measures body temperature continuously, providing remote notifications when a patient’s temperature is outside a clinician-specified range – giving peace of mind to caregiver and patient alike. Masimo SafetyNet uses a tetherless, wearable single-patient-use Masimo SET Measure-through Motion and Low Perfusion pulse oximetry sensor to monitor a patient’s blood oxygen saturation and pulse rate, as well as respiration rate, perfusion index, and PVi. Masimo SafetyNet is designed to help manage the surge in COVID-19 patients while maintaining distance from other patients and providers, allowing hospitals to expand remote patient monitoring into alternative care spaces, including overflow locations, emergency recovery facilities, and home care settings. The telehealth platform combines tetherless pulse oximetry—and now also Radius Tº continuous temperature measurement – with a cloud-based remote data capture and surveillance platform accessible from a patient’s Android or iOS smartphone or smart device. Monitoring key physiological data provides clinicians with the ability to assess patient status and facilitates awareness of the need for intervention. Temperature measurement by patients at home typically occurs intermittently, at the prompting of a clinician, and is prone to poor compliance in the collection and reporting of data to healthcare providers in a timely, consistent fashion. A patient taking their temperature at regular or semi-regular intervals may only notice a spike in temperature hours after a fever has begun, or may not even be aware of it, delaying possible clinical intervention. In contrast, Radius Tº collects data continuously and seamlessly, recording trend data and automatically notifying remotely when a clinician-specified high temperature threshold is breached, without any action needed on the patient’s part. By eliminating inconsistent manual measurements and concerns about patient compliance, while providing continuous insight into changes in body temperature, Radius Tº is intended to significantly improve patient status assessment workflows. Radius Tº is small, light, and comfortable, and is easily applied to the chest. Each shower-proof, single-patient-use sensor lasts up to 8 days and can be worn throughout the day and night, allowing patients to continue normal daily activities while still being monitored. Applied to the skin, Radius Tº uses proprietary algorithms to measure the patient’s body temperature, not just external skin temperature, with laboratory accuracy within ±0.1ºC, whereas other thermometry solutions typically have laboratory accuracy within ±0.2ºC. Using Bluetooth, Radius Tº provides this continuous data to the Masimo SafetyNet app on the patient’s smartphone and via secure cloud to clinicians back at the hospital, allowing them to track and trend a patient’s body temperature, helping them to spot potential deterioration in patient status using the web-based Masimo SafetyNet Clinician Portal. Joe Kiani, Founder and CEO of Masimo, said, “We’re proud to add this noninvasive, continuous, wearable thermometer solution to our growing family of remote patient management solutions. Masimo SafetyNet has already helped clinicians effectively care for countless patients during the pandemic. With the addition of Radius Tº, Masimo SafetyNet becomes an even more useful tool for remotely managing patients with COVID-19 and many other health concerns.” Radius Tº is indicated for use on patients 5 years and older. Radius Tº is not FDA 510(k) cleared; the device is marketed under the FDA’s Enforcement Policy for Clinical Electronic Thermometers During COVID-19.

Blood Test Signals Risk?


A low lymphocyte count in people presenting to the hospital with COVID-19 could help physicians identify those at higher risk for intensive care unit (ICU) admission, suggests new evidence from a retrospective cohort study of 57 patients. Lymphocytopenia was associated with more than a threefold increased risk for requiring ICU care compared with people with normal lymphocyte results at time of admission. Acute kidney injury also was more common among people with low absolute lymphocyte counts. Lingering Symptoms: Some recovered COVID-19 patients discharged from acute care need continued monitoring for long-lasting effects, according to new research. In a study of previously hospitalized COVID-19 patients, nearly 90% of 143 patients had at least one persistent symptom 2 months or longer after initial onset and at more than a month after discharge. About half of patients still had fatigue, 40% had dyspnea, 30% had joint pain, and 20% chest pain — none had fever or other signs and symptoms of acute illness. Thirty-two percent of patients had one or two symptoms and 55% had three or more. Change to Government Data Reporting: The Trump administration has issued new instructions for hospitals to report COVID-19 patient information to the US Department of Health and Human Services (HHS) for a central database, rather than through the Centers for Disease Control and Prevention (CDC) National Healthcare Safety Network. The New York Times, which first reported the change, also reported that public health experts expressed concern that the CDC would no longer be collecting the data, while officials said the change would streamline data gathering and assist the White House coronavirus task force in allocating personal protective equipment and the antiviral drug remdesivir. Too Many Trials? There has been an explosion of research into COVID-19, from its underlying biology to its potential treatments. Researchers recently quantified just how much: 674 specific randomized trials of COVID-19 interventions. Nearly a quarter of the treatment trials were testing chloroquine. "This could be a problem," F. Perry Wilson, MD, MSCE, says. One issue is that, with enough randomized trials of an intervention that doesn't actually work, some individual trials will nevertheless return positive results, and those results will be publicized. Second, more researchers should work together, Wilson says. "We need to foster collaboration across medical centers and research institutions, get these teams working together, do 20 really amazing trials instead of 120 mediocre ones."

Coronavirus-Related Syndrome Surfaces in Older Adults; Stillbirths Cause Worry


COVID-19 inflammatory syndrome now seen in adults. A rare and life-threatening condition seen in some children and young adults after exposure to the novel coronavirus is being reported in older adults now as well. The condition, known as Multisystem Inflammatory Syndrome in Children (MIS-C), can attack multiple organs, impair heart function and weaken heart arteries. Children initially experience fever, rash, conjunctivitis, lower-limb swelling, pain in arms and legs, and significant gastrointestinal symptoms. Doctors at New York University, in a report on Saturday in the Lancet medical journal, reported a similar case in a 45-year-old man. Doctors at Maimonides Medical Center in Brooklyn reported last month in the American Journal of Emergency Medicine a case in a 36-year-old woman. While both research teams cautioned against drawing conclusions from these isolated cases, they said they want to "heighten awareness" of the possibility that the syndrome can occur in adults.

London Hospital Reports Rise in Stillbirths during Pandemic


The number of stillbirths at one large London hospital has jumped significantly during the pandemic. In the four months preceding the pandemic, there were roughly two stillbirths among every 1,000 births at St George's University Hospital. From February through mid-June, there were roughly nine stillbirths per 1,000 births. The research appeared on Friday in the Journal of the American Medical Association. None of the women with stillbirths during the pandemic period had been diagnosed with COVID-19, the researchers said. But they noted that the coronavirus still may have been responsible given that previous research showed that up to 90% of infected pregnant women in Britain had no symptoms and therefore could not get tested for the virus. The increase in stillbirths also may be an indirect effect of the pandemic, they said. If women avoided visiting a doctor or hospital for fear of infection, serious problems might have been missed such as reduced fetal movements or dangerous pregnancy-related high blood pressure.

Blood Test Could Signal More Severe COVID-19 Risk


A low lymphocyte count in people presenting to the hospital with COVID-19 could help physicians identify those at higher risk for intensive care unit (ICU) admission, new evidence suggests. Patients with lymphocytopenia had a more than threefold increased risk for requiring ICU care compared with people with normal lymphocyte counts at time of admission. Acute kidney injury (AKI) also was more common among people with low absolute lymphocyte counts. With COVID-19, the severity of disease can vary widely. "Some patients have minimal to no symptoms, while others develop severe, debilitating disease requiring ICU admission. Prognostic markers are needed to triage these patients," co-author Ahmad Farooq, MD, from the Division of Gastroenterology, Hepatology and Nutrition, Department of Internal Medicine, University of Texas Health Science Center at Houston, and from the Division of Gastroenterology and Hepatology, Department of Internal Medicine, Duke University, Durham, North Carolina, said Farooq, lead author Jason Wagner, MD, from the Department of Internal Medicine, University of Texas Health Science Center, and colleagues reported the results of their retrospective cohort study online July 10 in the International Journal of Laboratory Hematology. "This study shows that absolute lymphocyte count below 1000 on admission is associated with ICU admission and organ damage, as noted by acute kidney injury," said Farooq. Prior research has linked lymphocytopenia with other viral illnesses, including severe acute respiratory syndrome (SARS), and Middle East respiratory syndrome (MERS). Although the mechanism driving a reduction of lymphocytes in COVID-19 remains unknown, "this is thought to be due to reduction of peripheral T cells by lymphocyte sequestration in specific target organs," Farooq said. Target organs include the lung, the gastrointestinal tract, and lymphoid tissue. To find out more, the researchers assessed electronic medical records for 57 adults diagnosed with COVID-19. All participants were admitted to an academic, community-based hospital in Houston between March 1 and May 7, 2020. A total of 18 people (31%) were admitted to the ICU. Half of this group required intubation, and seven of the patients received vasopressors. The average age of the study population was 58 years, 59% were men, and the average body mass index was 32 kg/m2. The majority of participants (86%) were of minorities.

Patients With Pulmonary Disease Shouldn't Quit Aerosolized Medication Over COVID Fears


COVID-19 concerns should not stop patients from using inhaled corticosteroids, a new commentary article suggests. While patients with pulmonary diseases are at increased risk of developing COVID-19, those treatments may actually reduce the likelihood of infection and the worsening of symptoms in those already infected with the virus, a respiratory specialist advises. "Patients with pulmonary disease should continue their regular treatment plan and continue taking their prescribed medications at home," said the author of the commentary, Azuri Ari, a professor in the department of respiratory care at Texas State University, in Round Rock. "Clinicians have been concerned about the use of steroids during the pandemic and patients specifically have been afraid of inhaled medications as a potential source of virus transmission and immunosuppression." In fact, Ari said, a recent study noted that SARS-CoV-19 infection rates appear to be lower in this population than with other chronic illnesses, and that might be because the medications are protective. Ari suggested precautions that could help stem the spread of the disease among housemates and family members. First, that clinicians prescribe inhalers over nebulizers whenever possible. "Exhaled air dispersion and virus transmission with inhalers are less than with jet nebulizers because inhalers have lower emitted doses and generate less aerosol mass," she writes in the commentary. "When the drug formulation is unavailable as an inhaler or patients cannot do the breathing techniques with inhalers, aerosols can be delivered with nebulizers."

The type of device used by most patients is the jet nebulizer, Ari said. “Previous research shows that two-thirds of the aerosols that jet nebulizers generate are released into the environment, which might increase the risk of infection for family members and other caregivers," she said, adding that a mesh nebulizer might be a better choice since fewer aerosols are released into the environment with this this type of device. Either way, the best way to protect caregivers, family members and housemates is to nebulize away from others, Ari said. "When a patient needs to take inhaled medications it should be done on the porch or patio or in their garage," Ari said. "That way emissions won't circulate and accumulate in the house." If that's not possible, then the patient should isolate themselves during treatment in a room away from everyone else, Ari said. The room should be well-ventilated with open windows and a meter away from family members, she added. "Patients should cover their noses and mouths with a tissue when coughing and should discard the used tissue in a trash can in the patient's room," Ari cautioned.

Viral Lung Protection with Filter Masks


With so much in the media and healthcare proclamations surrounding masks for protecting people from the coronavirus, it is important to understand the difference between masks, how they filter, and how to select the mask that serves the desired protection needs. Listening to even scientists on TV about wearing masks reflects the poor understanding of how masks work and the complexity of protecting a person’s breathing zone. Consider masks with valves, which are typically found on many N95 masks. N95 masks can be used for both industrial and medical indications. In most industrial applications where the workers are exposed to harmful particles in the air, N95 masks with valves are frequently preferred. The valve opens only on exhalation, which allows more exhaled heat and moisture to escape the mask, while filtering all of the air that the worker inhales. This makes the mask more comfortable to wear. However, in industries such as the semiconductor industry, where they need to protect the semiconductor from any particles in the worker’s breath, they only use N95 masks without valves.
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Independent Testing Confirms Human Coronavirus Efficacy


3B Medical announced completion of independent lab testing of Lumin used to decontaminate an N95 respirator. Lumin, a UV sanitizer, has a measured UVC irradiance output of roughly 2,000 mJ/cm2, well in excess of the dose requirement to kill most bacteria and viruses. This latest test study by Microchem utilized an N95 respirator inoculated with Human Coronavirus. In this study, Lumin evidenced greater than a 99.9% kill of Human Coronavirus. Lab results available upon request. Lumin is a high-powered UVC based sanitizing device, initially developed for home use to clean CPAP accessories in a mirrored chamber. It is lab tested to kill bacteria and germs, including human coronavirus and influenza. 3B Medical is a leader in the development; marketing and distribution of medical products for the treatment of sleep disordered breathing and oxygen therapy.

Severe Disease Not Uncommon in Kids Hospitalized With COVID-19


Children with COVID-19 are more likely to develop severe illness and require intensive care than previously realized, data from a single-center study suggest. Jerry Y Chao, MD, from the Department of Anesthesiology, Albert Einstein College of Medicine, Montefiore Medical Center, New York City, and colleagues report their findings in an article published online May 11 in the Journal of Pediatrics. "Thankfully most children with COVID-19 fare well, and some do not have any symptoms at all, but this research is a sobering reminder that children are not immune to this virus and some do require a higher level of care," senior author Shivanand S. Medar, MD, FAAP, attending physician, Cardiac Intensive Care, Children's Hospital at Montefiore, and assistant professor of pediatrics, Albert Einstein College of Medicine, said in a Montefiore Medical Center news release. The study included 67 patients aged 1 month to 21 years (median, 13.1 years) who were treated for COVID-19 at a tertiary care children's hospital between March 15 and April 13. Of those, 21 (31.3%) were treated as outpatients. "As the number of patients screened for COVID-19 was restricted during the first weeks of the outbreak because of limited testing availability, the number of mildly symptomatic patients is not known, and therefore these 21 patients are not included in the analysis," the authors write. Of the 46 hospitalized patients, 33 (72%) were admitted to a general pediatric medical ward, and 13 (28%) were admitted to the pediatric intensive care unit (PICU). Almost one third (14 children; 30.4%) of the admitted patients were obese, and almost one quarter (11 children; 24.4%) had asthma, but neither factor was associated with an increased risk for PICU admission. "We know that in adults, obesity is a risk factor for more severe disease, however, surprisingly, our study found that children admitted to the intensive care unit did not have a higher prevalence of obesity than those on the general unit," Chao said in the news release. Three of the PICU patients (25%) had preexisting seizure disorders, as did one (3%) patient on the general medical unit. "There was no significant difference in the usage of ibuprofen prior to hospitalization among patients admitted to medical unit compared with those admitted to the PICU," the authors write. Platelet counts were lower in patients admitted to the PICU compared with those on the general medical unit; however, C-reactive protein, procalcitonin, and pro–brain natriuretic peptide levels were all elevated in patients admitted to the PICU compared with those admitted to the general medical unit.

Asthma Prolongs Intubation Time in COVID-19 Patients


Asthma may prolong the time a person hospitalized with COVID-19 is on a ventilator, a new study suggests. "Although asthmatics might not be at higher risk to acquire the virus, once they do, asthmatics have a significantly more difficult time with longer intubation and ICU admission," Dr Mahboobeh Mahdavinia of Rush University Medical Center in Chicago said by email. To assess the impact of preexisting asthma on COVID-19 outcomes, the researchers studied 935 patients with confirmed COVID-19, of whom 241 (25.8%) had a diagnosis of asthma. Asthmatic patients with COVID-19 required intubation for about five days more on average than non-asthmatic patients with COVID-19 (P=0.01), the researchers report in The Journal of Allergy and Clinical Immunology: In Practice. The longer intubation time with asthma was seen in people aged 18 to 64 but not in those age 65 and older. This suggests that "younger individuals with asthma may require extra attention as they could develop a sustained pulmonary failure with COVID-19 infection, leading to a prolonged mechanical ventilation," the researchers write. The analysis was adjusted for both obesity and gender, which indicates that asthma is independently linked to intubation duration, they note. There was a trend toward longer hospital stays among patients asthma in those 50 to 64 years old but not in the younger or older age groups. Asthma was not associated with higher rate of death (1.1% vs. 3% in asthmatics vs. non-asthmatics, P=0.22) nor with acute respiratory distress syndrome (8.9% vs. 9.5%; P=0.92).

Antibody Testing Suggests Coronavirus More Widespread Than Expected in LA County


In early April, far more individuals in Los Angeles (LA) County had SARS-CoV-2 antibodies than previously thought, suggesting that confirmed cases don't reveal the true extent of infection in a given community, researchers say. "The findings also suggest that we are far away from herd immunity, and thus we should have a long-term planning horizon in evaluating policies for mitigating this disease," Dr Neeraj Sood of the University of Southern California said. "Public health departments in different counties and cities should conduct their own studies where they test a representative set of households in their communities," Dr Sood said. Such tests can "help target resources to areas with higher burden of disease (and) also identify racial/ethnic or socio-economic disparities in burden of disease." Principal author Dr Jayanta Bhattacharya, also of USC, added in a separate email, "An estimate of the prevalence rate will help clinicians in LA County provide better guidance to their patients about the meaning of a positive or negative antibody test result. Without an estimate of the prevalence rate, it is not possible to calculate either the positive predictive value or negative predictive value of a diagnostic test." Using a proprietary database, the researchers invited close to 2,000 people to be tested, of whom 863 agreed to participate: 55% were ages 35-54; 60%, women; 58%, white; and 43% with yearly household incomes greater than $100,000. Because the sample differed on demographics and income distribution from Los Angeles County overall, results were weighted to match the 2018 census on sex, race/ethnicity, and income. As reported in JAMA, a number of participants were symptomatic: 13% had fever with cough; 9%, fever with shortness of breath; and 6% loss of smell or taste. Thirty-five (4.06%) with varying demographics tested positive, for a weighted proportion of 4.31%. After adjusting for test sensitivity and specificity, the unweighted and weighted prevalence of SARSCoV-2 antibodies was 4.34% and 4.65%, respectively. "The estimate implies that approximately 367,000 adults had SARS-CoV-2 antibodies, which is substantially greater than the 8,430 cumulative number of confirmed infections in the county" at the time, the authors note.

More Severe COVID-19 in Patients With Liver Fibrosis


Patients with non-alcoholic fatty liver disease (NAFLD) and increased liver-fibrosis scores experience more severe illness from COVID-19, according to a study of Chinese patients. One recent study found that patients with severe COVID-19 were more likely than patients with nonsevere COVID-19 to have NAFLD. Among patients with NAFLD, the severity of liver fibrosis determines its prognosis. Dr Giovanni Targher of the University of Verona, in Italy, and colleagues investigated whether increased noninvasive liver-fibrosis score—fibrosis-4 (FIB-4) index and NAFLD fibrosis score (NFS)—are associated with an increased risk for severe illness from COVID-19 in 310 patients from Zheijiang Province in China with laboratory-confirmed COVID-19. Of these patients, 94 had NAFLD, including 44 with low FIB-4, 36 with intermediate FIB-4 and 14 with high FIB-4.

The odds of severe COVID-19 illness were increased 4.32-fold (P<0.001) in patients with intermediate FIB-4 scores and 5.73-fold in patients with high FIB-4 scores (P<0.005), the team reports in Gut.

Intermediate/high NFS was associated with 2.91-fold increased odds of severe COVID-19 illness after controlling for sex, obesity, and diabetes. Similarly, increasing FIB-4 or NFS as continuous variables were significantly associated with greater COVID-19 severity after adjusting for sex, obesity, diabetes and the presence/absence of NAFLD.

Comparing COVID-19, Flu Death Tolls 'Extremely Dangerous'


The number of COVID-19 deaths cannot be directly compared to the number of seasonal influenza deaths because they are calculated differently, researchers say in a report. Whereas COVID-19 death rates are determined from actual counts of people who have died, seasonal influenza death rates are estimated by the Centers for Disease Control and Prevention (CDC) using population modeling algorithms, explains Jeremy Samuel Faust, MD, with Harvard Medical School and Brigham and Women's Hospital, Division of Health Policy and Public Health in Boston, Massachusetts. The CDC estimates that between 24,000 and 62,000 people died from influenza during the 2019–2020 season (through April 4). At the time of the analysis (as of April 28), COVID-19 deaths had reached 65,000 in the United States. Some government officials and others have said the numbers seem similar and have used the comparison as an argument for reopening certain areas. But making that comparison "is extremely dangerous," Faust said. "COVID-19 is far more dangerous and is wreaking far more havoc than seasonal influenza ever has," he said. Faust coauthored the perspective article, with Carlos del Rio, MD, Division of Infectious Diseases at Emory University School of Medicine in Atlanta, Georgia. The message and methodology of Faust's and del Rio's article are on target, according to Jonathan L. Temte, MD, PhD, who has been working in influenza surveillance for almost 25 years. Current flu data draw on limited information from primary care practices and hospitals, said Temte, associate dean for public health and community engagement at the University of Wisconsin School of Medicine and Public Health in Madison. The estimates help bridge the gaps, he said, but the system is inherently vulnerable to error.

"Comparing them ― as so many people in this country have done ― to try to diminish the impact of SARS-CoV2 is not fair," he said. The authors illustrate the difference in the way rates of death from influenza are calculated: "Between 2013–2014 and 2018–2019, the reported yearly estimated influenza deaths ranged from 23,000 to 61,000. Over that same time period, however, the number of counted influenza deaths was between 3448 and 15,620 yearly." "It's apparent [the CDC has] been overestimating," Faust said. "If you publish a number on the higher end of the estimate, people might take your public health messages more seriously, such as, it's important to get your yearly flu shot."

COPD Patients Face Much Higher Risk of Severe COVID-19


Patients with chronic obstructive pulmonary disease (COPD) have more than four times higher odds of developing severe COVID-19 infection, while current smokers may also be more prone to severe disease, according to a new review and meta-analysis. "The results of this study indicate that pre-existing COPD is likely to worsen the progression and prognosis of Covid-19," Dr Qianwen Zhao of West China Hospital, Sichuan University, in Chengdu, and colleagues write in the Journal of Medical Virology. "Strong efforts should be directed to avoid infection in patients with underlying COPD." Early case series suggested that COPD and smoking were more prevalent among patients with severe COVID-19, the authors note, although a recent meta-analysis found no link between smoking and severe disease. Dr Zhao and colleagues reviewed 11 articles, one in Chinese and 10 in English, that included 2,002 patients, 334 of whom had severe COVID-19. Ten studies reported preexisting COPD in participants. Pooled odds ratio (OR) for severe COVID-19 was 4.38 for COPD patients (95% confidence interval, 2.34 to 8.20), with moderate heterogeneity among the studies. Pooled analysis of the seven studies that included information on smoking and COVID-19 severity found active smokers had an OR of 1.98 (95% CI, 1.29 to 3.05) for severe disease. When the authors excluded a study that was a "major source of heterogeneity," the increase was no longer significant (OR, 1.55; 95% CI, 0.83 to 2.87), however. The relationship between smoking and severe COVID-19 is "controversial," the authors note, and the excluded study was the only one to distinguish between current and ex-smokers. Also, not all studies reported smoking duration, they add. "It is well known that cessation of smoking improves pulmonary function, however, this benefit is less among older smokers due to the cumulative injury to lung over a prolonged period of time," the authors write. "These results indicate a complicated relationship between smoking history and the severity of Covid-19."

COVID-19 Panel: Helmet CPAP, Pronation Key Tools for Some Patients


Noninvasive ventilation with helmet continuous positive air pressure (CPAP) deserves to be embraced as an effective strategy in preventing self-induced lung injury, often a key factor in progression from the early milder expression of COVID-19 disease to classic severe acute respiratory distress syndrome, according to European physicians who have been through what they hope are the worst days of the pandemic in the Lombardy region of Northern Italy. Helmet CPAP is a relatively inexpensive, convenient, well-tolerated intervention. It allows patients to remain conscious and responsive to commands such as "Time to roll over," which in turn frees up nursing staff. The purpose of helmet CPAP is to curb the huge inspiratory drive that's a defining feature of this disease and which, unchecked, can lead to self-induced lung injury (SILI), Luciano Gattinoni, MD, explained at a webinar hosted by the European Society of Anaesthesiology. "Paranoid attention to inspiratory effort – checking it and correcting it – is something where we can make the difference between death and life. It's extremely important," said Dr Gattinoni, guest professor of anesthesiology and intensive care at the University of Gottingen (Germany). He and his fellow panelists were in accord regarding the merits of helmet CPAP as the premier method of noninvasive ventilatory assistance. They also addressed the importance of monitoring for hypercoagulation, as well as what they've come to see as the essential role of pronation in what they define as Type H disease, and the need to have detailed respiratory physiotherapy protocols in place.

"COVID-19 doesn't like physiotherapy," explained Paolo Pelosi, MD, professor of anesthesiology and intensive care medicine at the University of Genoa (Italy). Dr Gattinoni is credited for identification of two polar phenotypes of what he considers to be a single COVID-19 disease. Early on, many patients present with an atypical form of acute respiratory distress syndrome (ARDS), distinguished by an often-unexpected degree of hypoxia accompanied by high pulmonary compliance and surprisingly little shortness of breath. Dr Gattinoni and colleagues call this Type L disease, which stands for low elastane, low ventilation to perfusion ratio, low lung weight on CT, and low lung recruitability, which means the patient has a high proportion of aerated lung tissue. Over time, because of either the natural history of the disease or SILI, this may shift to Type H disease, marked by high elastane, high right-to-left shunt, high lung weight, and high recruitability. "If the pulmonary compliance is above 60 [mL/cm H2O], I'm pretty sure it's Type L. If it's 30 [mL/cm H2O] or less, I'm pretty sure it's Type H. Don't ask me about 45-55 [mL/cm H2O]; it's a grey zone," Dr Gattinoni said.

Case Report Details Success of Tankless Delivery System


GENOSYL DS, an innovative tankless delivery system for inhaled nitric oxide (iNO) was used by Stanford Medicine clinicians via telemedicine for outpatient, at-home treatment of a patient with pulmonary hypertension complicated by COVID-19, according to a case report published online in the American Journal of Respiratory and Critical Care Medicine, a premier journal in pulmonary and critical care medicine. Access Case Report here. The case, the first of its kind to report on at-home iNO treatment, involved a 34-year-old female with vasoreactive idiopathic pulmonary arterial hypertension (iPAH) and concomitant COVID-19 This patient was successfully remotely managed by clinicians. The clinicians obtained an Emergency Investigational New Drug Application (EIND) from the US Food and Drug Administration for the use of GENOSYL (nitric oxide) gas for inhalation, manufactured by VERO Biotech, a Georgia-based biotech company. Roham T. Zamanian, MD, Associate Professor of Medicine, Stanford University School of Medicine, Department of Pulmonary and Critical Care Medicine, was the case report’s lead author. “Without well-established treatments, the COVID-19 pandemic is a threat to the health and care of PAH patients. This report is the first to our knowledge of outpatient telehealth management of an iPAH patient with COVID-19, and represents a first step towards support for in home use of iNO in PAH, as well as the potential use of iNO in patients with coronavirusassociated pulmonary disease in the outpatient environment,” said Michael A. Gentile, Vice President of Medical Affairs, VERO Biotech and a co-author on the report. “While hospitals may readily stock the large, weighty tank system required for conventional delivery of iNO, the recent FDA approval of the GENOSYL tankless delivery system opens more realistic opportunities for out-of-hospital or even home use.” “VERO Biotech is pleased to play an important role in the treatment of patients with concomitant cardiopulmonary disease and COVID-19 infection,” commented Brent V. Furse, President and CEO, VERO Biotech. “We designed our novel delivery system to ease the burden of care on respiratory therapists, not only in the hospital setting but also for outpatient use,” he added. Researchers have observed that the COVID-19 pandemic of a novel coronavirus, SARS-CoV-2, is associated with significant cardiopulmonary morbidity in some patients.  As no specific antiviral therapy is available for SARS-CoV-2, treatment has been limited to supportive though sometimes intensive (particularly in older patients and those with comorbidities) measures, and has severely stretched global hospital staffing and equipment capacity in many countries. The advance in therapy reported in this case is an indication that home therapy with iNO may help ease those burdens.

New Grants Approved


The American Thoracic Society announced that GlaxoSmithKline(GSK) has awarded the Society two grants totaling $380,000 to support the ATS COVID-19 Crisis Fund, a newly launched initiative to develop and disseminate research, education and scientific recommendations to providers in the pulmonary and critical care communities, as well as other clinicians in need of expanding their skill set during this emergency. The first grant will fund two new $50,000 grants in the ATS Research Program in COVID-19. The second grant for $280,000 will support the Society’s patient education and outreach efforts related to COVID-19. The COVID-19 pandemic has posed significant challenges for pulmonary and critical care specialists worldwide. As a membership society of health care professionals committed to improving lung health, ATS is a leading voice in the discourse on initiatives to counter the spread of the coronavirus and provide support to those on the frontlines, who are treating patients diagnosed with COVID-19. In order to fulfill its mission to the greatest extent possible as COVID-19 ravages individuals and medical infrastructures worldwide, ATS is seeking industry support. GSK’s generous support comes at a critical time in the COVID-19 pandemic,” said ATS President James Beck, MD. “On behalf of the entire ATS community, I want to thank GSK for their very generous support. These funds will help support time-sensitive research and educational outreach to patients at a time when resources are so stretched. ATS values our partnership with GSK.” “We have a long history of working alongside the pulmonology and critical care community and, especially during this crisis, are proud to support ATS to advance critical research efforts and help educate patients who include some of the highest risk, most under-served members of our communities,” said, Karin E. Rosén, MD, PhD, senior vice president, US Medical Affairs, GSK. “We are committed to contributing to the fight against COVID-19 and this is one of many actions we are taking to help find solutions and provide support to ensure patients can receive the care they need. These efforts also include programs available to help patients access medicines and vaccines, including those impacted by COVID-19.”

High Level Disinfection via Pasteurization – a possible solution to COVID-19 limited supplies


Pasteurization has been used to destroy potentially pathogenic organisms in the food and beverage industry for decades. However, a medical device can also be pasteurized by fully immersing it in heated water for a specific amount of time at a specific temperature to achieve viral deactivation and microbial destruction. Global standards recommend that to achieve HLD, the process should apply, at minimum, a temperature of 65°C (ISO 15883). In the US, the amount of bioburden reduction required to achieve HLD is a 6-log reduction (which equates to a 99.9999% reduction) of the original population of organisms. A full immersion pasteurization using a Cenorin 610 Washer-Pasteurizer/High Level Disinfector at a temperature of 72°C for 30 minutes has been shown to achieve HLD for typical medical devices used in respiratory care, anesthesia, pulmonary procedures, and sleep labs. In a recent study, a ‘worst-case’ (time and temp parameters) method was tested using a Cenorin 610 Washer-Pasteurizer/High Level Disinfector. The wash/pasteurization cycle achieved industry clean levels and a greater than 8-9 log reduction for Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli and a representative of the Klebsiella-Enterobacter group. The Pasteurization cycle also yielded a 7-log reduction of Mycobacterium Terrae. Cenorin customers use the Cenorin 610 to clean and disinfect many devices that are critical in today’s environment. These include oxygen administration masks and head bands, ventilator breathing circuits, ventilator inhalation/exhalation check valve assemblies, and corrugated tubing. If there are additional devices, including PPE like masks and goggles, that you would like to have more information on, please reach out to us – we are available to help.

Getinge contributes to Ventilator Manufacturers Group to form Ventilator Training Alliance


Today several of the world’s ventilator manufacturers announce a newly formed Ventilator Training Alliance (VTA) to support frontline medical providers to access a centralized repository of ventilator training. The content can be found in a mobile app managed by Allego. “Supporting our customers and facilitating ventilator training continues to be key to all stakeholders in this project”, says Charles Merchant, Senior Director Global Therapy Development Acute Care Therapies at Getinge. “Dräger, GE Healthcare, Hamilton Medical, Medtronic, Philips, Vyaire Medical and Nihon Kohden, together with Getinge, have joined this humanitarian training coalition”. The VTA app — powered by learning and readiness platform provider Allego — connects respiratory therapists, nurses and other medical professionals with ventilator training resources from alliance member companies, including instructional how-to videos, manuals, troubleshooting guides, and other ventilator-operation expertise critical to treating patients suffering from COVID-19-related respiratory distress. Ventilators play a critical role in the management of patients who require assistance because they cannot breathe effectively due to severe respiratory illness, such as COVID-19. Speed and ease of access to ventilator training has a direct impact on patients’ health during the COVID-19 crisis. Content on the VTA app can be accessed on iOS and Android devices — even in environments with little to no Wi-Fi access — or from a web browser. The app provides healthcare professionals’ multi-language closed captioning and mobile background audio when multitasking. The app is provided at no cost to medical professionals. To download the Ventilator Training Alliance knowledge hub application, visit the Apple App Store or Google Play store, or access the hub from any Web browser.

Disposable CPAP Devices Donated


Mercury Medical, a healthcare manufacturer focused on introducing new critical care medical device technologies, announces the donation of 2,500 Flow-Safe II Disposable CPAP devices to the state of New York for treating COVID-19 patients. The FDA recently issued guidelines indicating that BiPAP and CPAP devices can be used to effectively help treat COVID-19 patients in Respiratory Distress. CPAP therapy has been shown to be very efficacious in preventing these patients from deteriorating to the point where they require mechanical ventilation. With the current shortage of mechanical ICU ventilators, these CPAP devices can play an important role in meeting New York's surge capacity to treat the influx of COVID-19 patients. Currently, the New York City Fire Department (FDNY) has been using Mercury Medical’s Flow-Safe II EZ disposable CPAP device for patients exhibiting symptoms of Respiratory Distress for the last few years. The Flow-Safe II family of products are disposable ventilatory support devices that deliver CPAP and/or Bilevel CPAP therapies. They do not require a mechanical machine or electrical power; simply connect to an oxygen source within the hospital to deliver adjustable CPAP pressures; can be disposed of after use to eliminate cross contamination; are simple to use and are very cost effective. John Gargaro, MD, Mercury Medical president and CEO, states, “We have been following daily updates regarding the growing spread of COVID-19 and the resulting health impact on the State of New York, especially in New York City and surrounding areas. We are donating 2,500 each of our Flow-Safe II product to help New York’s efforts in saving lives during this COVID-19 crisis. We believe that this product can be used effectively on coronavirus patients with the goal of minimizing the need for mechanical ventilators, thus freeing them up to be used on more critical cases.”

St. Luke's University Health Network One of the First in the World to Pilot Masimo SafetyNet


Masimo announced that St. Luke's University Health Network (SLUHN) is one of the first institutions worldwide to use Masimo SafetyNet to monitor in-hospital patients, as the network seeks innovative solutions to care for the surge of patients infected by COVID-19. Masimo SafetyNet is an innovative, economically scalable cloud-based patient management platform designed to help clinicians care for patients remotely in hospital settings and in non-traditional settings and circumstances. The telehealth solution uses a tetherless, wearable single-patient-use sensor to monitor patients with clinically proven Masimo SET pulse oximetry, and is designed to help manage the surge in COVID-19 patients while maintaining the safety of other patients and providers, allowing hospitals to expand patient remote monitoring into alternative care spaces, including overflow locations, emergency recovery facilities, and home care settings. Aldo Carmona, MD, St. Luke's Senior Vice President of Clinical Innovation and Chairman of the Department of Anesthesia and Critical Care, said, "This technology is game-changing in light of the crush of demand on our hospitals during this COVID-19 pandemic. With this wearable device, we can create temporary, pop-up respiratory monitoring units as needed to meet the changing patient volumes and track employees' health in their homes if they have been exposed to COVID-19, the flu, or any other serious illness." Designed to track the blood oxygen saturation and respiration rate of patients who are hospitalized or quarantined at home, Masimo SafetyNet combines tetherless SET pulse oximetry with a proprietary remote data capture and surveillance platform accessible from a patient's Android or iOS smartphone or smart device. Monitoring key physiological data can help provide clinicians with an accurate snapshot of a patient's systemic health and facilitates awareness of the need for rapid execution of treatment decisions that can be life-saving. Patients are provided with a multi-day supply of single-patient-use sensors and access to the Masimo SafetyNet mobile app. With clinical feedback from St. Luke's led by Dr. Carmona and from University Hospitals led by Dr Peter Pronovost, Masimo SafetyNet has been designed for easy, intuitive use to provide customized, interactive CarePrograms that align with expert guidance on COVID-19. Monitoring data collected by the sensor is shared with the patient’s smartphone using a secure Bluetooth® connection. Twice daily, or as directed, the CareProgram can be configured to actively notify patients to answer questions such as, "are you having trouble breathing?" and "what is your temperature?", and pushes these responses along with the monitoring data to clinicians for evaluation. CarePrograms are fully customizable to accommodate each institution's protocols, each patient’s needs, and any changes in COVID-19 guidance – and can be updated through the cloud by providers even after being deployed, for maximum flexibility as situations evolve. In addition to COVID-19 CarePrograms, Masimo SafetyNet can be configured for more than 150 other CarePrograms for use with COPD, heart failure, oncology, and other patients.

On March 30, patients at St. Luke's University Health Network Bethlehem diagnosed with COVID-19 were outfitted with Masimo SafetyNet. Non-COVID-19 patients are also being monitored with this system in general medical-surgical units. St. Luke's plans to use the Masimo SafetyNet tetherless sensor and cloud-based surveillance system to monitor upwards of 2,000 hospitalized patients and lower acuity cases in the home. These may also include staff and patients who are quarantined at home with the virus. "Our patients at St. Luke’s have the most sophisticated and reliable respiratory monitoring available anywhere," Carmona says. "We know that continuous physiologic monitoring with Masimo’s Patient SafetyNet improves outcomes and saves lives. The ability to extend that capability to patients in non-traditional settings and at home during this crisis with Masimo SafetyNet is transformative. Only through our relationship with Masimo could this have been possible."

Joe Kiani, Founder and CEO of Masimo, said, "Masimo is proud to be able to work with St. Luke’s to help protect the health and safety of medical professionals and the patients they serve during this global pandemic."

Device Mitigates Risks to Workers


In today’s unprecedented challenge to protect healthcare workers on the front lines as they battle the coronavirus pandemic, one Arizona company is providing a unique nebulizer system that is designed to optimize aerosol therapy and mitigate caregiver exposure to the contagion. Westmed, Inc.,, a leader in pulmonary medication delivery, introduced the original Circulaire Aerosol Drug Delivery System in 1997. In 2008, the company modified the Circulaire II with new features to create a quasi-closed device that significantly improved drug delivery performance, as well as the safety of the system. One enhancement included a unique Medication Reservoir, designed to retain the excess aerosol produced during nebulization which would subsequently be inhaled by the patient during inspiration, thus providing maximum output delivery of the nebulizer. As a result, only the Circulaire II System effectively doubles the dosage of medication with every breath. In addition to functioning as a holding chamber, conserving medication and enhancing aerosol delivery, the Reservoir also prevents room air dilution of medication to achieve the highest Fraction of Inhalable Aerosol in the industry. In fact, multiple studies confirm, the Circulaire System delivers more drug mass in less time than any other conventional nebulizer. Plus, a One-Way Valve virtually eliminates the risk of the patient re-breathing into the nebulizer, to protect the nebulizer and the Reservoir from contamination by exhaled pathogens. Further, of particular importance today, while not a complete solution, an integral Exhalation Filter in the Circulaire II, with bacterial >99.99% and viral >99.98 efficiencies, mitigates exposure to exhaled patient droplets and medication during aerosol therapy. The Circulaire II is the only aerosol delivery system available that includes an integral Exhalation Filter as a standard feature.

FDA Clears Blood Gas Analyzer Used for Critically Ill Patients in Acute Care Settings


Siemens Healthineers announced that its latest critical care testing solution, the RAPIDPoint 500e Blood Gas Analyzer, has received clearance from the US Food and Drug Administration. The analyzer generates blood gas, electrolyte, metabolite, CO-oximetry, and neonatal bilirubin results, which are used to diagnose and monitor critically ill patients in the intensive care unit, operating room, or emergency room. Already available in countries requiring the CE mark, the RAPIDPoint 500e Blood Gas Analyzer is now available for critical care testing in the United States. “Point-of-care teams monitoring respiratory conditions in critical care settings need a blood gas testing solution that delivers fast, accurate results and increases workflow efficiencies. A safe operating environment amid growing concerns about cybersecurity threats in healthcare is also important,” said Christoph Pedain, PhD, Head of Point of Care Diagnostics, Siemens Healthineers. “The RAPIDPoint 500e Blood Gas Analyzer has become a trusted instrument in Europe’s endeavor to combat COVID-19 and to help address an unprecedented demand for blood gas testing in affected respiratory patients.” The RAPIDPoint 500e Blood Gas Analyzer is an essential instrument supporting COVID-19 response efforts, where blood gas testing plays a critical role in managing infected patients and monitoring their respiratory distress. Routine blood gas testing is also performed when patients require mechanical ventilation. Arterial blood gas tests provide the status of a patient’s oxygenation levels and enable healthcare providers to determine whether adjustments to ventilator settings or other treatments are required. The analyzer elevates confidence in patient results with Integri-sense Technology, a comprehensive series of automated functional checks designed to deliver accurate test results at the point-of-care. “As an ICU physician, I know that the values I am handed during an emergency allow me to confidently make life-saving decisions. The RAPIDPoint system is easy to use and allows me to not worry about the machine and focus my attention on my patients,” said Dr Daniel Martin, Royal Free Hospital, London. Additionally, the RAPIDPoint 500e Blood Gas Analyzer integrates seamlessly into hospital networks with the Siemens Healthineers Point of Care Ecosystem, which offers convenient, remote management of operators and devices located across multiple sites. For more information about the RAPIDPoint 500e Blood Gas Analyzer, visit

Company Ramps Up Production


Getinge, the world market leader in advanced ventilators for intensive care units, announced another ramp-up in production capacity, to 26,000 ventilators in 2020. The increase equals a growth of 160% compared to 2019, when 10,000 ventilators were produced. The demand for advanced ventilators for the intensive care units in hospitals continue to increase globally as a result of the COVID-19 pandemic outbreak. Getinge is ramping up the production capacity stepwise at its production facility in Solna, Sweden, and is now increasing production capacity to 26,000 in 2020, compared to the previous planned 16,000 unit level that was communicated on March 17. The ramp up will start immediately and progress in close collaboration with Getinge’s suppliers. “We continue to ramp up to be able to respond to the increasing demand from our customers”, says Elin Frostehav, Vice President Critical Care at Getinge. “We work closely with our sub-contractors and the ramp up is of course pending availability of supply parts”. In 2019, Getinge produced 10,000 ventilators at the production facility in Solna. Since the start of 2020, Getinge has increased its production capacity with 160%, compared to 2019. The estimated increase in demand and production capacity of ventilators is expected to be accretive to Getinge’s result. Learn more about Getinge’s products at

Should CPAP Therapy be used with COVID-19 Patients?


Some clinicians are currently inquiring if CPAP therapy can be used with COVID-19 patients. According to the many experts, the response is an overwhelming YES! Josh Farkas MD, associate professor of Pulmonary and Critical Care Medicine at the University of Vermont states,“COVID patients really need positive pressure more than anything else. For example, their work of breathing is often tolerable – so they may not need much mechanical support for the work of breathing (indeed, mechanical support could lead to injuriously large tidal volumes).” The best modality to provide lots of positive pressure is simply Continuous Positive Airway Pressure (CPAP). CPAP may not seem dramatic, but this modality actually provides the greatest amount of positive pressure to allow for the most powerful recruitment.” Importantly, recently communicated new findings from the Intensive Care Society, (ICS), state, “CPAP may be of benefit to patients, (COVID-19), earlier on in the disease process than first thought and may prevent deterioration of some patients to the extent of them not going on to need invasive ventilation.” Mercury Medical markets technology that can provide both CPAP and Bilevel therapies using low cost Flow-Safe CPAP and Bilevel CPAP disposable devices. Current research supports the use of Flow-Safe Disposable CPAP devices. In addition, The American Journal of Emergency Medicine concludes that a disposable CPAP device, (Flow-Safe II Mercury Medical), is just as effective as a mechanical portable ventilator (Philips Respironics Trilogy 202). A continuum of care protocol can be established by placing COVID-19 patients on a disposal CPAP/Bilevel device upon entry to the EMSvehicle / ER Department; maintaining the same device during the hospital stay until an intensive care ventilator is indicated. The Flow-Safe disposable CPAP/Bilevel devices are packaged with non-vented full face deluxe masks. When used with an expiratory filter, they may reduce the incidence of cross contamination, are simple to use, require little training and run on medical grade air/oxygen systems currently available in hospitals today.

Help Offered to Fill Blood Shortages


Masimo announced that, in response to current worldwide blood shortages driven by the coronavirus pandemic, it is making rainbow licenses available for no additional charge to hospitals where rainbow-ready devices are already in use. The Masimo rainbow platform allows for the noninvasive and continuous monitoring of 12 parameters, including hemoglobin (SpHb), oxyhemoglobin (SpO2), and methemoglobin (SpMet). Once rainbow is enabled, hospitals can purchase RD rainbow sensors at discounted prices during this pandemic. The program is available globally and is planned to continue until the pandemic subsides. SpHb provides real-time visibility to changes, or lack of changes, in hemoglobin between invasive blood samples – and has been shown to help clinicians improve patient blood management. In multiple outcome studies, SpHb has been shown to help clinicians reduce blood transfusions. SpHb is available on a variety of Masimo Pulse CO-Oximeters, including the Root Patient Monitoring and Connectivity Platform, Radical-7, and Rad-97, as well as patient monitors from 25 other patient monitoring manufacturers, including Dräger and Philips. "Our goal is to make the biggest difference we can during this challenging time. This is our third initiative in the past four days to help clinicians deal with COVID-19. Many hospitals have seen the value of rainbow®, and we hope every hospital can now benefit from proven rainbow® noninvasive blood constituent monitoring technology," said Joe Kiani, Founder and CEO of Masimo. One of the many burdens COVID-19 is placing on health systems around the world is a shortage of blood products, as hospitals rush to treat an extraordinary surge of patients – at the same time that many blood drives have been cancelled. Therefore, hospitals are needing to manage blood supplies as efficiently and conservatively as possible. A growing body of evidence from around the world has shown that Masimo SpHb may help clinicians reduce unnecessary blood transfusions in both low- and high-blood-loss surgeries: A randomized trial of 327 patients undergoing elective orthopedic surgery found that the use of continuous, noninvasive hemoglobin monitoring with SpHb reduced the rate of transfusions by 87% when compared to standard care without continuous, noninvasive hemoglobin monitoring. A prospective cohort study of 106 neurosurgical patients found that adding SpHb monitoring to standard-of-care blood management resulted in decreased blood utilization in high-blood-loss neurosurgery by 41%, while also decreasing time to transfusion when indicated by 41 minutes. A study of 100 patients undergoing abdominal cancer surgery found that SpHb monitoring decreased blood utilization by 39%, while facilitating earlier transfusions when indicated by 33 minutes. A study of 237 patients undergoing hip trauma surgery found that continuous SpHb monitoring during high-blood-loss surgery reduced the percentage of patients needing blood transfusions by 7% and number of transfused units per patient by 13%. In addition to SpHb, the rainbow family of advanced noninvasive parameters includes SpMet, which helps clinicians noninvasively and continuously monitor methemoglobin levels in the blood. Elevated methemoglobin levels can be caused by inhaled nitric oxide (iNO) therapy, which is currently being investigated as a potential treatment for lung complications associated with COVID-19. By allowing clinicians to monitor methemoglobin levels, SpMet may be an important monitoring tool during iNO therapy. SpHb and SpMet are not intended to replace laboratory blood testing. Clinical decisions regarding red blood cell transfusions should be based on the clinician's judgment considering, among other factors, patient condition and laboratory diagnostic tests using blood samples.

Study Looks at Integrated Clinical Surveillance Monitoring


Masimo announced the results of a recently published ten-year retrospective study in which researchers at Dartmouth-Hitchcock Medical Center investigated the impact of an integrated clinical surveillance monitoring system, using Masimo SET and Patient SafetyNet technologies, on mortality related to the use of prescribed opioids in the general ward. Over the ten years studied, of 111,488 patients in units with surveillance available, there were zero patient deaths and no patients were harmed by opioid-induced respiratory depression while continuous monitoring was in use. In contrast, among patients in units without surveillance available, there were three deaths. The surveillance monitoring system provided continuous monitoring using Masimo SET Measure-through Motion and Low Perfusion pulse oximetry, and was comprised of Masimo Radical-7 and Rad-87 Pulse CO-Oximeters, Root Patient Monitoring and Connectivity Hubs, and Masimo Patient SafetyNet, which provided supplemental remote monitoring at central view stations and alarm and alarm escalation notifications to clinicians' pagers. Monitored parameters included oxygen saturation (SpO2) and pulse rate (PR). The researchers reviewed ten years of data collected from 2007 to 2017, over which time there were 126,697 general care unit discharges. Dr Sue McGrath and colleagues at Dartmouth-Hitchcock Medical Center found that, over the 10 years, of the 111,488 patients in units with surveillance monitoring available, "none died or were harmed by opioid-induced respiratory depression when surveillance monitoring was in use." Of the 15,209 patients in unmonitored units, three patients died from opioid overdose. The reduced death rate when surveillance was available, compared to when it was not available, was statistically "significant" (p=0.03). A fourth patient died in a unit where surveillance monitoring was available but Masimo technology was not being used at the time of the adverse event. The researchers noted, "The fact that one patient with known risk for opioid sensitivity died while in a unit where monitoring was available but not in use highlights the importance of system adoption and adherence to standards of care." The researchers concluded, "For a 10-year period, the rescue system with continuous surveillance monitoring had a profound effect on death from sedative/analgesic administration in the general care setting. This approach to patient safety can help address the risk of sedative/analgesic-related respiratory arrests in hospitals." Regarding the cost of deploying such a system, the researchers noted, "Although cost is often raised as a barrier to implementation, a previously performed financial analysis demonstrated cost-effectiveness of surveillance monitoring due primarily to intensive care unit patient days avoided when early detection of patient deterioration occurs." They continued, "This study confirms that surveillance monitoring for pharmacologically induced respiratory arrest in hospitalized patients can virtually eliminate deaths due to this serious but treatable complication. In other high-risk, safety-focused industries, the level of evidence that currently exists for continuous surveillance monitoring to mitigate the risk of accidental sedative/analgesic overdose would likely prompt immediate calls for widespread implementation of safety interventions." Joe Kiani, Founder and CEO of Masimo, commented, "We are incredibly grateful to Dr McGrath, her colleagues, and everyone at Dartmouth-Hitchcock Medical Center for demonstrating the value of continuous monitoring of post-surgical patients over a ten-year period. Hundreds of other hospitals have adopted our technology and have reported similar results. We hope that this new study will inspire every other institution to implement Masimo SET on their general floor to eliminate preventable deaths due to opioid overdose, especially at this time when illnesses that impact the respiratory system, such as COVID-19, are so prevalent." In previously published studies at Dartmouth-Hitchcock Medical Center, researchers found that after deploying the continuous monitoring system in the original 36-bed unit, there was a 65% reduction in rapid response team activations and a 48% reduction in transfers back to the ICU. After five years of use, they reported zero preventable deaths or brain damage due to opioids, as well as cost savings of $7 million, and after ten years, they reported maintaining a 50% reduction in unplanned transfers and a 60% reduction in rescue events, despite increases in patient acuity and occupancy.

Mallinckrodt and Novoteris Receive Clearance from Health Canada


Mallinckrodt plc, a global biopharmaceutical company, and Novoteris, LLC, a clinical stage medical device and pharmaceutical developer focused on innovative nitric oxide gas applications, announced that the Therapeutic Products Directorate of Health Canada has cleared the companies' joint pilot clinical trial, entitled "Inhaled Gaseous Nitric Oxide (gNO) Antimicrobial Treatment of Difficult Bacterial and Viral Lung (COVID-19) Infections" application to investigate the use of Thiolanox, a high-dose inhaled nitric oxide therapy for the treatment of patients infected with novel coronavirus (SARS-CoV-2) at Vancouver Coastal Health Authority facilities. The investigative therapy employs Novoteris' Inhaled Nitric Oxide Delivery Device (INODD) and Mallinckrodt's high-concentration, 5000 PPM nitric oxide gas for inhalation canisters. The study will investigate the therapy's safety and effectiveness in treating COVID-19 and its associated lung complications. The companies expect to begin recruiting patients in the coming days. "Inhaled nitric oxide may have an antiviral effect, as well as improve oxygenation and pulmonary arterial pressure in patients suffering from COVID-19," said Steven Romano, MD, Executive Vice President and Chief Scientific Officer at Mallinckrodt. "We're proud to be partnering with Novoteris on this pilot trial and are committed to increasing understanding of this potentially important therapeutic option for healthcare providers on the front lines of this unprecedented health emergency." COVID-19 is a contagious respiratory illness caused by a novel coronavirus. Patients with COVID-19 have mild to severe respiratory illness that can include symptoms such as cough, fever and shortness of breath.1 In severe cases, COVID-19 can cause acute respiratory distress syndrome (ARDS) – a disorder in which fluid leaks into the lungs, making breathing difficult or impossible – and can lead to multi-organ failure and sometimes death. "Our collaboration with Mallinckrodt to study high-dose inhaled nitric oxide to treat patients with COVID-19 and associated lung complications is an exciting step in both companies' commitment to helping the world battle this global pandemic," said Alex Stenzler, Founder and President at Novoteris. Inhaled nitric oxide (iNO) has been evaluated in randomized controlled trials, both in pediatric and adult patients with ARDS, and demonstrated partially dose-dependent improvement in blood oxygenation and decreased pulmonary artery pressure and, in one trial, improvements in the composite measure of days alive or free of ventilator support at day 28 of the trial (the last day evaluated). There have been other trials evaluating iNO in the context of ARDS, which have demonstrated mixed results. In an in vitro study, inhaled nitric oxide has demonstrated an inhibitory effect on the replication cycle of severe acute respiratory syndrome-related coronavirus (SARS-CoV). Furthermore, a small clinical trial in SARS-CoV patients demonstrated improvements in blood oxygenation, a reduction in supplemental oxygen and a reduction in the amount of ventilator support. "This is an important day for patients and healthcare providers," said Chris Miller, PhD, Assistant Professor, Faculty of Medicine at University of British Columbia and Founder and Scientific Advisor at Novoteris. Dr Miller, team lead for the study at Vancouver Coastal Health Research Institute, and an expert in nitric oxide therapies, with a research career spanning more than 25 years studying the antimicrobial effect of high-dose nitric oxide to treat lung infections, said, "I am very pleased to be working with Mallinckrodt and Novoteris on this study using high-dose inhaled nitric oxide for patients with COVID-19." Mallinckrodt is currently working with the US Food and Drug Administration on the possibility of making the company's INOmax (nitric oxide) gas, for inhalation product available to US patients with pulmonary complications of COVID-19 as quickly as possible through the appropriate regulatory mechanism. INOmax has been on the market in the US since 2000, and is indicated for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. Please see Important Safety Information below. The safety and efficacy of INOmax and iNO for pulmonary complications associated with COVID-19 have not been established. For more information, visit

Cuff Pressure Management While Keeping a Safe Distance


Safety with HVLP cuffs. The TRACOE smart cuff manager can be used with tracheostomy tubes as well as endotracheal tubes. This innovative product allows a visual control at a safe distance. Being a single patient product, the risk of cross infection is reduced to a minimum. The main function of this product is to keep the cuff pressure at a stable range between 20 and 30 cm H2O. This helps minimize the risk of silent aspiration and improper sealing which can cause damage to the respiratory system. Additionally, it reduces the risk of aerosol formation due to insufficient cuff pressure. Find more information at

Fighting COVID-19 is Our Mission


The mission of IngMar Medical is to decrease patient suffering and improve outcomes is fueled by the actions you are taking right now, and we want to help you win this fight. We hope this knowledge base will help you enable others to act in this crisis. Thank you for your unwavering courage and dedication to healthcare. Watch and share our recorded presentations to learn essential information on mastering the art of mechanical ventilation, particularly for patients diagnosed with COVID-19. These presentations provide e-learning content as well as hands-on demonstration of training scenarios. Download complimentary scenario simulations that you can run on your ASL 5000 Breathing Simulator. These simulations will enable you to provide hands-on training and develop your staff’s competency in treating a patient diagnosed with COVID-19, supported by mechanical ventilation. Browse the resources we used to inform our COVID-19 scenario simulations as well as basic training tools and videos meant to help clinicians understand the proper use of most major ventilators. Visit for more details.

Protecting Healthcare Workers from Patients with COVID-19


COVID-19 is a highly contagious virus, with an infectivity rate even higher than SARS. Patients progress from simple upper respiratory symptoms to requiring supplemental oxygen to intubation and mechanical ventilation. During the period of requiring supplemental oxygen and particularly during the periods where they may require aerosol therapy, healthcare workers at their bedside are exposed to aerosolized particles exiting their oxygen delivery devices. In most cases, when just using an oxygen mask, the aerosolized particles exiting laterally from holes in the mask for exhalation, bath the healthcare worker in particles that may not be visible to the naked eye. During the SARS epidemic the design team from 12th Man Technologies developed the Hi-Ox oxygen mask, that has no holes in the mask and all inspired and exhaled gas is delivered to the patient through one-way valves. Not only is it able to deliver higher FiO2s than a NRBM, all exhaled air flows down the front of the patient’s body and not towards the healthcare workers standing at their side. Some centers have added a filter to the expiratory limb to capture the exhaled contaminants. The Ontario Ministry of Health has recommended the Hi-Ox as the mask to use for oxygen delivery during respiratory pandemic outbreaks. Tri-Anim Healthcare is a distributor of the Hi-Ox.

Best Practices for COVID-19


For the prevention of COVID-19 spread, the focus has been correctly placed on the issue of community transmission. This includes clinical settings like hospitals or health practices where there is now increased respiratory testing demand due to the virus. It is important that Bacterial Viral Filters (BVF) be in use during these procedures to reduce the contamination risk to equipment such as spirometers as well as the surrounding test environment. This practice, in addition to routine cleaning procedures, will significantly reduce the chance of transmission among patients and staff. Professor Colum Dunne of the University of Limerick and colleagues tested Vitalograph BVFs to assess their effectiveness in preventing bacterial or viral transfer to and from respiratory testing equipment. Results showed >99.99% effectiveness for the prevention of microbial transfer to the testing equipment. BVFs also reduced potential transfer from the equipment to the users to a level below detectable limits. This suggests that BVFs should be used whenever possible during the use of respiratory diagnostic equipment. Vitalograph also recommends surface cleaning of flowheads between each patient using 70% isopropyl alcohol. Professor Dunne believes that these practices will reduce the risk of spreading COVID19, and other bacteria or viruses, between patients in clinical settings.

Ventilator Specs Shared


Medtronic, is publicly sharing the design specifications for the Puritan Bennett 560 (PB 560) ventilator to enable participants across industries to evaluate options for rapid manufacturing to help doctors and patients dealing with COVID-19. This decision is consistent with the recent FDA Guidance and in accordance with the public health and medical response of governmental agencies globally.

Introduced in 2010, the PB 560 is sold in 35 countries around the world and can be used in a range of care settings. PB 560 product and service manuals, design requirement documents, manufacturing documents, and schematics are now available at The PB 560 design specifications are available today, software code and other information will follow shortly. The PB 560 ventilator is a compact, lightweight, and portable ventilator that provides airway support for both adults and children. It can be used in clinical settings and at home and provides mobile respiratory support. Bob White, executive vice president and president of the Minimally Invasive Therapies Group at Medtronic, said: “Medtronic recognises the acute need for ventilators as life-saving devices in the management of COVID-19 infections. We know this global crisis needs a global response. Over the past few weeks, we have ramped up production of our Puritan Bennett 980 ventilators. But we also know we can do more, and we are. By openly sharing the PB 560 design information, we hope to increase global production of ventilator solutions for the fight against COVID-19.” Ventilators play a critical role in the management of patients with severe respiratory illness, such as COVID-19, who require assistance because they cannot breathe effectively. By placing a patient on a ventilator, the patient’s lungs are permitted to rest and recover while the ventilator performs the functions of supplying oxygen and simulating the actions of breathing. Without ventilation support, some patients with severe respiratory disease might not survive.

Hospitals Facing Ventilator Shortage


A New York hospital system has begun treating two patients instead of one on some ventilators, a desperate measure that could help alleviate a shortage of the critical breathing machines and help hospitals around the country respond to the surge of coronavirus patients expected in the coming weeks. NewYork-Presbyterian Hospital, began “ventilator sharing” this week, said Dr Laureen Hill, chief operating officer at the Presbyterian/Columbia University Irving Medical Center system. Doctors have developed protocols for the maneuver and now are rapidly scaling it up while also sharing their methods with the federal and state governments and other hospitals. Ventilator sharing has been explored in a few scientific studies and has been used twice in crisis situations — the immediate aftermath of the 2017 Las Vegas shooting and, as of several days ago, by an emergency physician, Dr Marco Garrone, for coronavirus patients in Italy. This is believed to be the first time that it has been put forth as a longer-term strategy in the United States. “We’re doing something that hasn’t really ever been done before,” said Dr. Jeremy Beitler, a pulmonary disease specialist at NewYork-Presbyterian/Columbia. “Now is the time to do it.” Gov. Andrew M. Cuomo of New York said on Thursday that the state had approved the new method, which is also being studied by federal officials. And this week, the Food and Drug Administration granted emergency use approval to a device called VESper, developed by the South Carolina-based Prisma Health, that adapts one ventilator for use with four patients. The New York action reflects the intense need felt worldwide to make ventilators serve more of the sickest Covid-19 patients. Generally, when patients are mechanically ventilated, a flexible tube is placed into their windpipe, and a finely calibrated pump sends oxygen-rich air into the lungs. In a video, a doctor uses a T-tube and three adapters to split two valves into four ports, and suggests positioning the patients headfirst around the machine. Dr Babcock and her colleague Dr Greg Nyman had published a study of the hack in 2006 — but tested it on four lung simulators, not patients. “Here’s my disclaimer: This is off-label use for a ventilator,” she says in the video. “If it was me, and I had four patients, and they all need intubation, and I only had one ventilator, I would simply have a shared discussion meeting with all four families and say, ‘I can pick one to live, or we can try to have all four live.’” NewYork-Presbyterian is using ventilator sharing for only two patients at a time who need settings on the ventilator that are very similar. Dr Beitler emphasized that each patient is still receiving the same amount of oxygen and level of care as previously. Sharing will not immediately double ventilator access, he added, because many patients will need their own. The hospital has not yet run out of ventilators, but Dr. Beitler said it was better to try the technique now than “when you have absolutely no choice.” Notably, he believes the technique will not increase staffing needs. With about 175,000 ventilators in hospitals and the federal stockpile, other states are also braced for shortages. Coronavirus patients often need to stay on ventilators for days or weeks. The subject of splitting ventilators is “highly controversial” among respiratory specialists, said Dr Josh Farkas, an assistant professor of pulmonary and critical care medicine at the University of Vermont. “While this is a technique that potentially could work for maybe a few hours, there are some significant hurdles,” said Dr MeiLan Han, a pulmonologist at the University of Michigan Health System and a spokeswoman for the American Lung Association. Among the concerns are the inability to monitor the impact on each individual; the potential for cross-contamination of infectious pathogens; and the possibility that instead of one person receiving lifesaving treatment, multiple patients would get dangerously subpar therapy.

Best Practices for Infection Control


As concern over the COVID-19 virus continues to grow and many labs are discontinuing all non-essential testing, MGC Diagnostics has received many inquiries as to the best practice for infection control when using our devices. Our products, although not critical care or emergency medical devices, are used to assess, diagnose and monitor the effect of COVID-19 on patients. The safety of our customers, their staff and patients is of utmost importance to us. Having clear and defined infection control policies is important for your protection. As such, we wanted to provide some guidance regarding infection control and cleaning options. MGC Diagnostics gives you three options for infection control — letting you make the choice that is right for your facility. 1. CHANGE — Simply change the filter and keep the same preVent flow sensor and BreathPath patient circuit. 2. RE-USE — Change the flow sensor and patient circuit between patients and replace with disinfected components. 3. DISPOSE — Dispose of the flow sensor and patient circuit after each patient. Changing out the patient test supplies can be done in 1 min with no warm-up time or recalibration of the system.

Safety Net Announced


Masimo and University Hospitals (UH), one of the largest health systems in Northeast Ohio, today jointly announced Masimo SafetyNet, an innovative, economically scalable patient management system designed to help clinicians care for patients remotely. The telehealth solution combines tetherless Radius PPG pulse oximetry, driven by breakthough Masimo SET Measure-through Motion and Low Perfusion technology, with Doctella, a secure, home-based, remote patient surveillance platform accessible from a patient's iOS or Android smartphone or smart device. The COVID-19 health emergency has significantly increased the demand for remote monitoring and patient engagement solutions in multiple settings. To proactively prepare for a surge in COVID-19 patients while maintaining the safety of other patients and providers, this new solution allows UH and other hospitals to expand patient monitoring to the home or to other facility locations set up temporarily to care for the increased demand. Current WHO guidelines recommend the monitoring of suspected or confirmed COVID-19 patients' oxygen saturation (SpO2), respiration rate (RR), and temperature, and Masimo and UH are meeting this increased demand by adapting existing technology to deliver a secure remote solution. Masimo SafetyNet offers care teams a single-platform solution that couples a secure, cloud-based surveillance platform with clinically proven SET pulse oximetry, estimated to be used on more than 200 million patients each year. In addition to SpO2, Radius PPG is capable of continuously monitoring pulse rate (PR), perfusion index, PVi, and RRp, respiration rate from the photoplethysmograph. Patients can be sent home with a multi-day supply of single-patient-use Radius PPG sensors and access to the Doctella mobile app, designed for easy, intuitive patient use via a digital home-care plan, or CareProgram, that aligns with expert guidance on COVID-19. Radius PPG shares its SpO2, PR, and RRp data with Doctella using secure Bluetooth wireless technology. In addition, Doctella can manually collect other physiological data, such as temperature. Twice daily, or as directed, the Doctella CareProgram actively notifies patients to answer questions such as, "are you having trouble breathing?" and "what is your temperature?", and securely pushes these responses along with physiological monitoring data to hospital-based clinicians for evaluation. The Doctella clinician portal allows providers to easily track patient compliance, helping them identify when intervention may be needed, as well as providing insight to help providers prioritize patients. CarePrograms are fully customizable to accommodate each institution’s protocols, each patient's needs, and any changes in COVID-19 guidance—and can be updated through the cloud by providers even after being deployed, for maximum flexibility as situations evolve. "We appreciate Masimo’s immediate collaboration to stand up this innovative platform that will significantly aid in our ability to scale up remote monitoring and meet the demand for patient care while addressing capacity and safety issues," explained Peter Pronovost, MD, UH Chief Clinical Transformation Officer. "For our patients with congestive heart failure or chronic obstructive pulmonary disease (COPD), we can provide them with this remote monitoring capability so they do not risk a COVID-19 infection by being near potentially infected patients. Similarly, for patients with a confirmed COVID-19 diagnosis, we can appropriately isolate them from other patients while ensuring they have the access to state-of-the-art care for managing their health through the recovery process." Joe Kiani, Founder and CEO of Masimo, said, "We thank the nurses and doctors who are bravely toiling in hospitals taking care of us all during this pandemic. We are delighted that we can help them triage and effectively take care of COVID-19 patients the best they can with Masimo SafetyNet. It has been a delight to work with UH to bring this technology to the health care industry to help them address the challenges they face during this unprecedented time." "This alliance demonstrates UH's strategy to drive improvements in population health," said Daniel I. Simon, MD, UH Chief Clinical & Scientific Officer and President, UH Cleveland Medical Center. "By deploying 'outside-in' tactics and forming this partnership with Masimo, our patients receive cutting edge treatment approaches while we help enhance the product for future users and industry transformation."

MGCD Partnership with University to Develop Low-cost Ventilator


As spread of COVID-19 continues throughout the country, demand for medical ventilators could skyrocket. Many are already expressing concerns about potential shortages, but there’s a doctor at the University of Minnesota who says he just created a simpler, cheaper ventilator that could save lives. University of Minnesota Anesthesiology fellow Dr Steve Richardson started work on his ventilator last Sunday, sourcing equipment and resources from biomedical engineer friends and other private companies. MGC Diagnostics is a partner in the project. Within hours of starting, Richardson finished a simple, effective prototype that he is now perfecting. He says if the FDA clears a path for production, he could scale it quickly, producing thousands within three weeks at a fraction of the cost of a traditional hospital ventilator. “People have just been working around the clock every day since Sunday morning, and we have a ventilator that I would be comfortable being anesthetized with,” Richardson said. If you would like to donate resources, supplies, research, manpower or funds to continue this project, visit

Tube Holder Ready to Use


As you prepare for the possibility of treating COVID-19 patients, Dale Medical stands ready to assist. The Dale Stabilock Endotracheal Tube Holder is the preferred holder for prone position ventilation. Since the Stabilock is soft and low profile, the holder is a comfortable way to secure the tube and minimize risk of pressure sores. Clinicians have access to the patient's mouth to monitor and care for the ET tube. The Dale Stabilock Endotracheal Tube Holder helps prevent accidental extubation by providing a secure method of stabilization. The Stabilock provides fast and easy application to secure endotracheal tubes sized 7.0-10.0mm. With four placement options for its Adhesive Base, the Dale Stabilock Endotracheal Tube Holder covers the full spectrum of patient needs.

Company Working to Keep You Safe


A message from ResMed CEO Mick Farrell: “As a global leader in respiratory medicine, ResMed stands with the world in the face of the latest coronavirus disease COVID-19 and is ready to help mitigate its effects, helping people breathe while their immune system fights this virus. More than 7,500 ResMedians are working in over 140 countries for this purpose. We are working with governments, health authorities, hospitals, physicians, and patients worldwide to assess their needs, and to deliver the ventilation therapy that is essential to treat the respiratory complications of COVID-19. Our primary focus is to maximize the availability of ResMed ventilators and other respiratory support devices for the patients that need them most. As global leaders in digital health, we’re proud that many of our ventilators and bilevel respiratory devices are cloud-connected, enabling physicians and respiratory specialists to remotely monitor their patients. There could not be a clearer case for the use of digital health and remote monitoring of patients than this current crisis with a virus that is so contagious stemming from direct human contact. I’m grateful to our global team for working through today’s challenges to help treat an increasing number of COVID-19 patients. I’d like to call out first-responder ResMedians in China’s Hubei province, the epicenter of the coronavirus outbreak, in particular one ResMed hero who, since early January, has donned a positive pressure hazmat suit, and helped set up thousands of people on ResMed ventilators and ResMed masks. There are also 100-plus ResMedians from Malaysia who in mid-March volunteered to keep working in our Singapore manufacturing plant when Malaysia closed its borders, relocating to live near our plant in Singapore, spending weeks away from their families, so they can continue to produce as many lifesaving ventilators and ventilation masks as possible. ResMed is taking every measure possible worldwide to maximize the production of ventilators, masks, and other respiratory devices. We are looking to double or triple the output of ventilators, and scale up ventilation mask production more than tenfold. Our team is also taking precautions such as a work-from-home policy for all employees who can do that, social distancing, and ensuring world-class quality, safety, good manufacturing practices, and top-level hygiene procedures at our manufacturing, service, and distribution centers to help ensure quality, safety, and business continuity. I urge all of us to do our part to help reduce the spread of the coronavirus, whether that is self-quarantining, working from home, sheltering in place, or just staying healthy for our families, particularly the elderly and those with compromised immune systems. Let me close with this: I would like to personally thank the front-line clinical heroes – many thousands of respiratory therapists, respiratory nurses, pulmonary and critical care medicine physicians, as well as hospital and clinical staff who set up our ventilators and masks for patients in need and deliver the lifesaving gift of breath... You are the superheroes of this COVID-19 crisis, and we salute you!”

Ventilation Production Stepped Up


GM and Ventec Life Systems, in cooperation with, the nation's coordinated private sector response to COVID-19, are collaborating to enable Ventec to increase production of its respiratory care products to support the growing fight against the COVID-19 pandemic. Ventec will leverage GM’s logistics, purchasing and manufacturing expertise to build more of their critically important ventilators. To support these efforts, will continue to unite business leaders across the country to collect resources to complement and support government efforts. “With GM’s help, Ventec will increase ventilator production,” said Chris Kiple, Ventec Life Systems CEO. “By tapping their expertise, GM is enabling us to get more ventilators to more hospitals much faster. This partnership will help save lives.” “We are working closely with Ventec to rapidly scale up production of their critically important respiratory products to support our country’s fight against the COVID-19 pandemic,” said Mary Barra, GM Chairman and CEO. “We will continue to explore ways to help in this time of crisis.”

As Coronavirus Looms, Mask Shortage Gives Rise to Promising Approach


3B Medical filed an Emergency Use Application (EUA) with FDA seeking authorization to market Lumin to reprocess N95 face masks. There is a huge shortage in protective apparel for healthcare workers. Lumin exceeds the UVC irradiance output required to kill human coronavirus and is useful for disinfecting N95 masks for re-use. We have been bombarded with healthcare workers urging us to file an EUA application with FDA, which we have now done. As an example, see the attached. Facing a dire shortage of protective face masks for health care workers, administrators at the University of Nebraska Medical Center decided they had no choice. Masks are certified for one-time use only. But on Thursday, the center began an experimental procedure to decontaminate its masks with ultraviolet light and reuse them. Administrators plan to use each mask for a week or longer. To the knowledge of the program’s administrators, the medical center is the first to disinfect and reuse masks. “We have talked with a lot of others around the country who are going after a similar approach,” said John Lowe, the medical center’s assistant vice chancellor for health security training and education, who designed the program. When administrators made the decision, they knew the procedure violated regulations promulgated by the Centers for Disease Control and Prevention, which said that if masks were decontaminated they could no longer be certified for use. But agency has issued new guidance, saying that “as a last resort, it may be necessary” for hospitals to use masks that were not approved by the National Institute for Occupational Safety and Health. That change would seem to mean it is now acceptable for hospitals to decontaminate and reuse masks during the coronavirus pandemic, said Shawn Gibbs, a professor of environmental health at Indiana University. If that were not the case, he added, then many hospitals would find themselves in a tightening bind as gear shortages spread: “What is preferred — not using respirator protection equipment, or using a decontaminated respirator whose certification is voided?” No one thinks reuse of face masks is ideal, and the practice may raise legal liability issues. But there seemed to be little choice. Doctors and administrators at the University of Nebraska Medical Center calculated that if they continued to use masks only once, they would run out of masks in just weeks. “We are making the best of bad choices,” said Dr Mark Rupp, the medical center’s chief of infectious diseases. He feels confident that the masks will still protect health care workers. “The data is very clear that you can kill and inactivate viruses with UV germicidal irradiation,” he said. “It is also very clear that you will not damage the respirators.” The alternative, Lowe said, would be to ask health care workers to carefully store their masks and reuse them without cleaning them. Handling a mask repeatedly also increases the chances that it will be contaminated. “Health care workers are very apprehensive about that,” he said.

Continuous Surveillance for Caregivers


There may not be an adequate number of skilled caregivers to manage the increased numbers of patients in respiratory distress that require assisted invasive and noninvasive ventilation. Adding continuous surveillance allows caregivers to view medical device settings, measurements and alerts for changing patient conditions from a centralized location. It can also help staff limit their exposure to infection, with fewer bedside visits, while still managing patients closely. Continuous clinical surveillance can help extend the reach of ICU staff over the full range of intensive care patients, wherever they receive care in the facility. Capsule Ventilated Patient Surveillance workstation (using the Bernoulli One Enterprise Software) can provide: Centralized view of ventilator data (FiO2, Set Tidal Volume, Exhaled Tidal Volume, Set RR; Total RR, Peak Inspiratory Pressure, Positive End Expiratory Pressure for each patient); Centralized alarming and alerting based on Surveillance pre-configured rules (smart rules) reviewed and approved by clinical decision makers. During the COVID-19 pandemic, Capsule are offering to add continuous clinical surveillance for ventilated patients to your Capsule Medical Device Information Platform (MDIP) installation: No-charge software license access for limited time use; Capsule Ventilated Patient Surveillance; Discounted implementation services; Remote, turnkey solution to speed deployment; Additional configuration beyond the base, may be billed at standard hourly rates; Hardware runs on any workstation that meets specifications. Upon request, Capsule will work jointly with customer on procurement.

Production Accelerated


Hillrom announced actions it is taking to support customers and caregivers with critical care products necessary to meet COVID-19 patient needs. Hillrom’s business operations continue with no material interruption as global demand for several critical products has grown substantially. The company is working to significantly ramp up production of these products, with the goal of more than doubling capacity in the following areas: Respiratory health, especially Life2000, a non-invasive ventilator currently approved in the US that is portable, lightweight and ideal for treating patients with mild to moderate respiratory distress across various acute care settings, including the emergency department, med-surg and post-ventilator weaning support. Expanded use of non-invasive ventilation can free up capacity for invasive ventilators for the most serious COVID-19 patients. Hillrom is working to increase its production capacity of Life2000 five-fold on an annualized basis. ICU and med-surg unit smart beds, including the company’s Progressa ICU bed, Centrella; Smart+ bed, and, for international markets, the Hillrom 900 and Hillrom 900 Accella. Patient monitoring and diagnostics, including the company’s Connex and Spot Vital Signs monitors as well as physical assessment tools and consumables, including thermometry, probe covers and blood pressure devices and cuffs. “We are committed to scaling production as rapidly as we can to meet the challenges the world is facing with COVID-19,” said Hillrom President and CEO John Groetelaars. “Hillrom’s critical care, vitals monitoring and respiratory products can help caregivers and patients as coronavirus continues to cause severe illness around the world. We are focused on our employees’ health and safety, and on ensuring that our products are available when and where our customers and patients need them.” Hillrom relies on a global supply chain and has a balanced global manufacturing footprint, with manufacturing facilities located in the US, Europe, Asia and Mexico. The company has seen no material disruption in its supply chain to date. Hillrom’s suppliers are a critical component of successfully meeting customer demand, and the company is working with its supply chain partners to minimize any potential disruption. Given the fluidity of the coronavirus pandemic, Hillrom will continue to monitor and assess business operations, and will provide additional information as appropriate.

Hillrom Makes Donations


Hillrom announced it is donating an additional $3 million in medical devices well-suited for critical and intensive care environments to 25 US hospitals fighting COVID-19. Combined with prior donations in Asia, Europe and other philanthropic activities in our communities, Hillrom donations to assist caregivers and patients in the current pandemic total more than $5.5 million to date. “Hillrom’s diverse portfolio is uniquely suited to help caregivers and patients fighting the COVID-19 pandemic,” said Hillrom President and CEO John Groetelaars. “We feel a deep responsibility as a healthcare company to help our communities expand access to critical care. We are honored that the American Hospital Association is supporting our initiative by spreading the word among the nation’s hospitals so that we can get the Critical Care and Respiratory Support products where they are needed most.” The Hillrom for Humanity Critical Care and Respiratory Support Program includes ICU beds, patient monitoring and respiratory health devices. Hospitals selected for the donations will each receive: Two Progressa ICU beds, One Welch Allyn Connex vital signs monitor; and three respiratory health technologies: the Life2000 non-invasive ventilator; the MetaNeb System, for oscillation lung-expansion therapy; and The Vest, which provides high-frequency chest-wall oscillation. Interested hospitals must meet certain eligibility criteria, including demonstration of need, community transmission of COVID-19, and the ability to put the devices to immediate clinical use. Applications may be submitted by any US hospital and will be vetted solely by Hillrom’s Global Compliance Office and Medical Affairs and Informatics Department. Hospitals meeting the criteria will be chosen to receive the Hillrom for Humanity Critical Care and Respiratory Support Program donations on a first-come, first-served basis. The medical devices received as part of this program are unrestricted donations to the hospitals without any relationship to any current or future business opportunities. Interested US hospitals should visit the Hillrom COVID-19 Resource Center on for more information and to apply. “The women and men of America’s hospitals and health systems are on the front lines every day, treating and helping prevent the spread of COVID-19,” said American Hospital Association President and CEO Rick Pollack. “We appreciate Hillrom’s important donations to help hospitals, health systems and health care providers expand access to critical care technologies as they respond to the novel coronavirus pandemic.”

“Close cooperation with the private sector has been a key piece of the Trump Administration’s response to the COVID-19 outbreak, and Hillrom’s donation of equipment for critical care units is the latest example of how those partnerships are bearing fruit,” said HHS Secretary Alex Azar. “The active engagement we’ve seen from companies like Hillrom will be essential to ensuring that American healthcare providers have the supplies they need to combat the COVID-19 outbreak and save American lives.” In January, Hillrom donated more than $2 million in vital signs monitors to the Chinese Red Cross to assist with efforts to better diagnose and help treat COVID-19 during the initial spread of the coronavirus within China. Today, Hillrom made a $50,000 cash donation to the American Nurses Foundation to build upon the organization’s efforts to support the needs of US nurses during and after the COVID-19 outbreak. And the company continues to provide local support in its communities as well.




Company Selects New Distribution Partner

DEC 3 2021

Prodol Meditec, SA, manufacturer of the Airtraq video laryngoscope and camera system, has selected Mercury Medical as their Exclusive North America Distributor partner for their state-of-the-art video laryngoscope product line effective January 1, 2022. This exclusive agreement includes distribution in Canada and Puerto Rico. Airtraq simplifies video laryngoscopy with its ETT channel guide aiding in safety and in reducing intubation time. The fully disposable system with its 90-degree shape works with the anatomy minimizing the need for hyperextension while reducing force. There is no need for a stylet avoiding potential injury while eliminating additional intubation equipment costs. Airtraq facilitates intubation from any position with clinical evidence of high intubation success rates and is easy to learn. The optional lightweight Wi-Fi camera facilitates video recording and auto recording options. Mercury Medical is a leading provider of cutting-edge technology in the acute care and emergency markets both in the United States and globally – a philosophy that is fully in line with Airtraq. John Gargaro MD, President and CEO states: “Our mission is delivering clinically differentiated critical care technology that saves lives throughout the world. As such, Mercury Medical believes that the Airtraq is a superior solution designed to improve outcomes in patients requiring intubation. As a company, Mercury Medical has a rich experience in introducing and educating clinicians on innovative, clinically differentiated medical devices. We are extremely pleased to partner with Airtraq in this endeavor to advance intubation practices. The clinical evidence supporting Airtraq’s superior performance is strong and aligned with Mercury Medical’s mission.” Danny Daniel, Airtraq’s VP of North America Sales states, “Airtraq is very excited to appoint Mercury Medical as our exclusive US partner. The core philosophy of our two companies is very much aligned together. We strive to innovate clinically differentiated products that improve provider care and saves precious lives. We look forward to a long and fruitful partnership together as we continue to bring cutting edge airway management technology to our customers.”

Rhinosinusitis Without Nasal Polyps Lowers QoL in COPD

NOV 30 2021

Concomitant rhinosinusitis without nasal polyps (RSsNP) in patients with chronic obstructive pulmonary disease (COPD) is associated with a poorer, disease-specific, health-related quality of life (HRQoL), a Norwegian study is showing. "Chronic rhinosinusitis has an impact on patients' HRQoL," lead author Marte Rystad Øie, Trondheim University Hospital, Trondheim, Norway, said in an email. "We found that RSsNP in COPD was associated with more psychological issues, higher COPD symptom burden, and overall COPD-related HRQoL after adjusting for lung function, so RSsNP does have clinical relevance and [our findings] support previous studies that have suggested that rhinosinusitis should be recognized as a comorbidity in COPD," she emphasized. The study sample consisted of 90 patients with COPD and 93 control subjects, all age 40-80 years. "Generic HRQoL was measured with the Norwegian version of the SF-36v2 Health Survey Standard questionnaire," the authors write, and responses were compared between patients with COPD and controls as well as between subgroups of patients who had COPD both with and without RSsNP. Disease-specific HRQoL was assessed by the Sinonasal Outcome Test-22 (SNOT-22); the St. Georges Respiratory Questionnaire (SGRQ), and the COPD Assessment Test (CAT), and responses were again compared between patients who had COPD with and without RSsNP. In the COPD group, "severe" and "very severe" airflow obstruction was present in 56.5% of patients with RSsNP compared with 38.6% of patients without RSsNP, as Øie reports. Furthermore, total SNOT-22 along with psychological subscale scores were both significantly higher in patients who had COPD with RSsNP than those without RSsNP. Among those with RSsNP, the mean value of the total SNOT-22 score was 36.8 whereas the mean value of the psychological subscale score was 22.6. Comparable mean values among patients who had COPD without RSsNP were 9.5 and 6.5, respectively (P < .05). Total scores on the SGRQ were again significantly greater in patients who had COPD with RSsNP at a mean of 43.3 compared with a mean of 34 in those without RSsNP, investigators observe. Similarly, scores for the symptom and activity domains again on the SGRQ were significantly greater for patients who had COPD with RSsNP than those without nasal polyps. As for the total CAT score, once again it was significantly higher in patients who had COPD with RSsNP at a mean of 18.8 compared with a mean of 13.5 in those without RSsNP (P < .05). Indeed, patients with RSsNP were four times more likely to have CAT scores indicating the condition was having a high or very high impact on their HRQoL compared with patients without RSsNP (P < .001). As the authors point out, having a high impact on HRQoL translates into patients having to stop their desired activities and having no good days in the week. "This suggests that having RSsNP substantially adds to the activity limitation experienced by patients with COPD," they emphasize. The authors also found that RSsNP was significantly associated with poorer physical functioning after adjusting for COPD as reflected by SF-36v2 findings, again suggesting that patients who had COPD with concomitant RSsNP have an additional limitation in activity and a heavier symptom burden. As Øie explained, rhinosinusitis has two clinical phenotypes: that with nasal polyps and that without nasal polyps, the latter being twice as prevalent. In fact, rhinosinusitis with nasal polyps is associated with asthma, as she pointed out. Given, however, that rhinosinusitis without polyps is amenable to treatment with daily use of nasal steroids, it is possible to reduce the burden of symptoms and psychological stress associated with RSsNP in COPD.
Limitations of the study include the fact that investigators did not assess patients for the presence of any comorbidities that potentially could contribute to poorer HRQoL in this patient population.

Sleep-Disordered Breathing Could Inflate Risk for Severe COVID-19

NOV 15 2021

People with sleep-disordered breathing or sleep-related hypoxia — low oxygen levels during sleeping — are no more likely than other adults to get infected with SARS-CoV-2 and develop COVID-19. However, if infected, they are at a 31% higher risk of getting hospitalized or dying from the illness, new research reveals. Investigators looked at almost 360,000 patients tested for COVID-19 at the Cleveland Clinic system. This group included 5400 people who also completed a sleep study. They also accounted for other factors that could alter COVID-19 risk, including obesity, heart and lung disease, cancer, and smoking. "In those with COVID-19, baseline oxygen lowering during sleep was associated with increased association with hospitalization and mortality, even after consideration of factors which could confound this relationship," Cinthya Pena Orbea, MD, said. When asked if she was surprised by the 31% increased risk, Pena Orbea said, "While this was consistent with our a priori  hypotheses and we were careful to take in to account pulmonary disease and smoking history, we still identified a statistically significant association." Pena Orbea is on staff at the Sleep Disorder Center and is assistant professor of medicine at the Cleveland Clinic Lerner College of Medicine of Case Western Reserve University in Ohio. Identifying another group at potentially higher risk for adverse outcomes could help allocate COVID-19 resources earlier or more appropriately, senior study author Reena Mehra, MD, director of sleep disorder research at Cleveland Clinic, said in a news release. "As the COVID-19 pandemic continues and the disease remains highly variable from patient to patient, it is critical to improve our ability to predict who will have more severe illness," she said.

COVID-19 Pandemic Fueled the Growth of Telemedicine in Allergy

NOV 15 2021

The use of telemedicine has historically been low among allergy practitioners compared with other specialists, but the pandemic has accelerated the growth of virtual allergy visits. "My own practice went from zero to 100% telemedicine in a matter of days," Susan Bailey, MD, an allergist at Fort Worth Allergy and Asthma Associates, in Fort Worth, Texas, and immediate past president of the American Medical Association, said during a plenary session at the American College of Allergy, Asthma, and Immunology (ACAAI) 2021 Annual Meeting, held in New Orleans. "I think the pandemic really pushed people out of necessity to adopt telehealth, or really decide if it's for them or not, quicker than they might have," said Melinda Rathkopf, MD, director of the Allergy, Asthma and Immunology Center of Alaska, in Anchorage, in an interview before co-moderating a telemedicine session at the conference. Across medicine, practitioners are seeing 50 to 175 times the number of patients through telehealth than they were before the COVID-19 pandemic, and nearly half of doctors are continuing to use telehealth as the pandemic causes shifts in practice patterns and the delivery of care. These trends are shown in McKinsey survey data that were presented at the ACAAI meeting by Jennifer Shih, MD, allergist-immunologist and assistant professor of pediatrics and internal medicine at Emory University, in Atlanta, Georgia. Several factors allowed telemedicine to grow. During the pandemic, the US Department of Health and Human Services relaxed the requirement that telehealth delivery be HIPAA compliant. Thus, physicians were able to use Zoom, Skype, Facetime, and other everyday technologies for virtual visits. In addition, the Centers for Medicare & Medicaid Services (CMS) instituted a number of changes to make telehealth more accessible — among them, recognizing a patient's home as an originating site and allowing virtual visits for new patients in addition to established ones. Before COVID-19, "I could not initiate a telehealth visit with someone I had never met in person for the first time. In Alaska, that included an in-person physical," said Rathkopf. "Those rules were all lifted during the pandemic." As more practitioners started offering telehealth, 46% of US consumers said they were using telehealth in lieu of canceled healthcare visits, up from 11% in 2019, according to McKinsey data that Shih reported at the meeting. More than three quarters of consumers said they would likely use telehealth after the pandemic. Of 297 patients who used telehealth services at Emory Allergy Clinic between March 24 and May 29, 2020, 88% of them rated their comfort level on seeing a doctor virtually with the highest score (10 out of 10) on a survey published by Shih and colleagues. Forty percent rated their telehealth visit equivalent or superior to a traditional outpatient encounter. And in a consumer survey conducted by Accenture, 64% of patients said they would change practitioners if they couldn't see the doctor via telehealth.

Novel Bronchoscopic Interventions Appear Promising for Patients With COPD

NOV 15 2021

Several emerging bronchoscopic treatments have the potential to improve the quality of life for patients with chronic obstructive pulmonary disease, an investigator reported at the annual meeting of the American College of Chest Physicians. Targeted lung denervation is one promising novel therapeutic option that is safe and may improve clinical outcomes according to investigator Christian Ghattas, MD. Data from an ongoing phase 3 randomized controlled trial may provide new information on the efficacy of targeted lung denervation in patients with chronic obstructive pulmonary disease (COPD), said Dr Ghattas, assistant professor of medicine and associate program director for the interventional pulmonary fellowship at The Ohio State University Medical Center in Columbus. “Outcome data of longer follow-up on previously treated patients will provide us with more information on the durability and the effect of this treatment,” Ghattas said in an online presentation at the CHEST meeting, which was held virtually this year. Meanwhile, a few compelling bronchoscopic treatment modalities for patients with chronic bronchitis are in earlier stages of clinical development. “Larger randomized, controlled trials are ongoing to confirm the available data and to evaluate treatment durability,” said Dr. Ghattas. The targeted lung denervation system under study (dNerva®, Nuvaira Inc.) involves the use of a radiofrequency catheter to ablate the peribronchial branches of the vagus nerve, Dr Ghattas said. The goal of disrupting pulmonary nerve input is to achieve sustained bronchodilation and reduce mucous secretion, thereby simulating the effect of anticholinergic drugs, he added. In pilot studies, the targeted lung denervation system demonstrated its feasibility and safety, while modifications to the system reduced the rate of serious adverse events, according to Dr Ghattas. In the AIRFLOW-1 study, which evaluated the safety of the latest generation version of the system, 30 patients with COPD were randomized to targeted lung denervation at one of two doses, 29 or 32 watts. Of those 30 patients, 29 (96.7%) had procedural success, meaning the catheter was inserted, guided to its intended location, and removed intact with no reported in-hospital serious adverse events, according to results published in Respiration. There was no difference between arms in the primary endpoint, which was the rate of adverse airway effects requiring intervention that were associated with targeted lung denervation, investigators reported. Four such events occurred, in 3 of 15 patients treated with 32 watts and 1 of 15 patients treated with 29 watts. Procedural success, defined as device success without an in-hospital serious adverse event, was 96.7% (29/30). The rate of TLD-associated adverse airway effects requiring intervention was 3/15 in the 32 W versus 1/15 in the 29 W group (P  = .6). However, serious gastric events were noted in five patients, prompting safety improvements and procedural enhancements that reduced both gastrointestinal and airway events, according to the study report.

Life-Threatening Paradoxical Bronchospasm May Be Missed in COPD or Asthma

NOV 15 2021

A rare and potentially life-threatening adverse effect of bronchodilator therapy may be overlooked among patients with chronic obstructive pulmonary disease (COPD) or asthma, according to a researcher who reviewed spirometry test results from US military veterans. Nearly 1.5% of the tests met the criteria for paradoxical bronchospasm, which refers to airway constriction that may rapidly occur after inhalation of a short-acting beta2 agonist (SABA) such as albuterol. However, none of those reports alluded to paradoxical bronchospasm, said investigator Malvika Kaul, MD, fellow in the department of pulmonary and critical care at the University of Illinois at Chicago and the Jesse Brown Veterans Affairs Medical Center, also in Chicago. “Paradoxical bronchospasm was neither recognized nor reported in any spirometry test results,” Dr Kaul said in an online poster presentation at the annual meeting of the American College of Chest Physicians, held virtually this year. By recognizing paradoxical bronchospasm, health care providers could address its clinical implications and identify potential alternative management options, according to Dr Kaul. “We hope in the future, education of clinicians about this phenomena is emphasized,” Dr Kaul said in her presentation. In an interview, Dr Kaul said she began researching paradoxical bronchospasm after encountering a patient who had an acute reaction to albuterol during a pulmonary function test. “I was not taught about it, and I wasn’t recognizing that pattern very frequently in my patients,” she said. Prescribing information for Food and Drug Administration–approved SABAs include a warning that life-threatening paradoxical bronchospasm may occur, said Dr Kaul. If paradoxical bronchospasm occurs, the patient should discontinue the medication immediately and start on alternative therapy, according to the available prescribing information for albuterol sulfate. Paradoxical bronchospasm has been linked to worsened respiratory outcomes, including more frequent exacerbations, in patients with obstructive lung diseases, according to Dr Kaul. Two previous large studies pegged the prevalence of paradoxical bronchospasm at around 4.5% in patients with COPD or asthma, but “it has not been reported or addressed in high-risk population, such as veterans who have high prevalence of obstructive lung diseases like COPD,” Dr Kaul said.

Researchers Team Up to Study COVID-19 Impact on Lung Function

NOV 08 2021

Boehringer Ingelheim announced that the first patient has enrolled in a new clinical study to observe whether COVID-19 patients with respiratory failure are more susceptible to developing progressive Interstitial Lung Disease (ILD), or scarring of the lungs. Weill Cornell Medicine and NewYork-Presbyterian Hospital are leading the clinical trial. “There is increasing evidence that respiratory failure observed in COVID-19 infected patients leads to a progressive form of Interstitial Lung Disease,” said Rob Kaner, M.D., principal investigator, associate professor of clinical Medicine and of Genetic Medicine and director of the Interstitial Lung Disease Program at Weill Cornell Medicine in New York, and a pulmonologist at NewYork-Presbyterian/Weill Cornell Medical Center. “This prospective study will define the incidence of progressive ILD in the COVID-19 patient population and investigate if there are specific biomarkers that may identify patients at risk for progression.” The study, NCT05074875, is a 48-week observational, prospective registry study that will enroll an estimated 300 patients who were hospitalized with hypoxemic (below normal oxygen levels) respiratory failure associated with COVID-19 at Weill Cornell Medicine and NewYork-Presbyterian Hospital, and three other medical centers. The primary endpoint of the study is the change in fibrotic and non-fibrotic interstitial opacities on chest HRCT at 48 weeks after hospitalization for COVID-19 or outpatient COVID-19 infections which require treatment with supplemental oxygen. Secondary endpoints include percentage of participants with changes from baseline and evidence of disease progression based on HRCT, relative change in Forced Vital Capacity (FVC) at weeks 12, 24, 48 and 72 among other measures. “This study will help the medical community better understand the prognosis of COVID-19, namely whether a progressive form of ILD and associated biomarkers may occur following respiratory failure in COVID-19 patients,” said Craig Conoscenti, M.D., Executive Director/Therapeutic Area Head, Respiratory IPF/ILD, Clinical Development and Medical Affairs, Boehringer Ingelheim. “It is our hope that this study will take a major step forward in providing treating doctors with new information to better help hospitalized patients affected by respiratory failure due to COVID-19 infection.”

Masimo Root with a Multimodal Brain Monitoring Algorithm May Improve Postoperative Neurocognition in Elderly Patients

NOV 08 2021

Masimo announced the findings of a prospective study published in Frontiers in Aging Neuroscience in which Dr Shuyi Yang and colleagues at Capital Medical University in Beijing investigated whether Masimo Root with a multimodal brain monitoring algorithm to manage anesthesia during spinal surgery could improve postoperative cognitive function. In the first study of its kind, the algorithm incorporated measurements from Root, including Masimo SedLine Brain Function Monitoring, Masimo O3® Regional Oximetry, and ANI Analgesia Nociception Index. The researchers concluded that managing anesthesia based on the multimodal algorithm “may improve the post-operative cognitive function and brain function connectivity in elderly patients undergoing spinal surgery compared to routine anesthesia management.” Noting that perioperative neurocognitive disorder (PND) is common in elderly patients undergoing surgery, and that PND has been associated with levels of sedation, analgesia, and cerebral oxygen saturation, the researchers sought to evaluate whether use of an algorithm designed around related parameters could help improve this population’s postoperative neurocognition. They enrolled 26 patients aged ≥ 65 scheduled to undergo spinal surgery and divided them randomly into an intervention group (n=14) and a control group (n=12). In the intervention group, anesthesia was managed using the algorithm, which incorporated Sedline Patient State Index (PSi) and Spectral Edge Frequency (SEF), O3 regional cerebral oxygen saturation (rSO2), ANI pain index, mean arterial pressure (MAP), end-tidal CO2 (PETCO2), hemoglobin (Hb), and temperature. The control group received routine anesthesia management. To evaluate whether the algorithm improved cognitive function, they a) compared the patients’ Montreal Cognitive Assessment (MoCA) score before and 7 days after surgery, b) analyzed the amplitude of low-frequency fluctuation (ALFF) and brain functional connectivity (FC) after MRI, c) measured serum C-reactive protein (CRP) and lipopolysaccharide levels, and d) analyzed the correlation between FC and changes in inflammatory marker levels. The researchers found that the mean postoperative MoCA score was higher in the intervention group (24.80 ± 2.09) than in control group (22.56 ± 2.24) (p = 0.04), with no significant difference in the incidence of PND between the groups. (The MoCA score was also higher in the intervention group than in the control group preoperatively, but to a lesser degree than postoperatively.) They also found that patients in the intervention group had significantly increased ALFF values in several brain regions after surgery (p < 0.05) and enhanced FC between the left hippocampus and several regions (p < 0.05), which was negatively correlated with the change in serum CRP (pre- vs. post-intervention) (r = -0.58, p = 0.01). The authors concluded that “anesthesia management based on multimodal brain monitoring under general anesthesia may improve the postoperative cognitive function and brain function connectivity in elderly patients undergoing spinal surgery compared to routine anesthesia management, as evidenced by increased brain activity (ALFF), enhanced FC, higher MoCA score, and reduced systemic inflammation. The extent of postoperative systemic inflammation was negatively associated with the FC enhancement and may be accompanied by a lower MoCA score. Our findings provide a basis for more effective management of elderly patients who undergo surgery to reduce the risk of cognitive disorders and improve brain function. Michael A.E. Ramsay, MD, FRCA, Chair Emeritus of the Department of Anesthesiology and Pain Management at Baylor University Medical Center, commented, “Postoperative neurocognitive disorders (PNDs) are commonly seen in elderly patients, and may be very distressing to the patient and family. This small, prospective, randomized clinical study has demonstrated that precision multimodal monitoring of the brain intraoperatively can result in significantly improved mental status of surgical patients postoperatively. The study patients were maintained at a precise depth of anesthesia, cerebral oxygenation, analgesia, and temperature using the Masimo Root monitor. Postoperatively the MoCA score was statistically higher (p < 0.04) in the study group and the inflammatory marker levels in the brain were significantly reduced (p < 0.05), as well as inflammatory markers systemically (p < 0.01). A MoCA score of 25-30 represents normal cognition and 21-24, 10-20, and 9 and below, mild, moderate, and severe cognitive impairment, respectively.” Dr Ramsay continued, “This was a well implemented study, and while it may have been small, it has large implications regarding the value of precision monitoring during surgery and with the potential for application in the intensive care unit (ICU). This may represent a vital advance in the prevention of PND and also the prevention of delirium in ICU patients. Larger studies will be needed to confirm these preliminary data.” ANI on Masimo Root has not received FDA clearance and is not available for sale in the US.

Ventilator Recall Sparks Changes

NOV 08 2021

The recall of some positive airway pressure devices and mechanical ventilators prompted some researchers to study how to optimize a transition to nonrecalled devices. Researchers with the Division of Pediatric Pulmonology, Department of Pediatrics, Children's Healthcare of Atlanta, Emory University, Atlanta, Georgia, launched a retrospective study of children after a Philips Respironics recall notification issued in June 2021 that affected many of their positive airway pressure devices and mechanical ventilators including the Trilogy 100 and 200 ventilators that are often utilized in children using home positive pressure ventilation via tracheostomy (PPV‐T).

“Optimal strategies to replace ventilators in children using home PPV‐T affected by the Philips recall are unknown,” the researchers wrote in their study, entitled “Ventilator change in children on home mechanical ventilation affected by the Philips Respironics trilogy ventilator recall,” and published in October 2021. “We conducted a retrospective study of children using home PPV‐T with recalled Trilogy ventilators who underwent inpatient ventilator change to non‐recalled portable home ventilators (PHV) using our collaborative institutional protocol. During the study period, there were 40 children using PPV‐T with recalled Trilogy ventilators and 19 patients underwent inpatient ventilator change either during an elective hospitalization (n = 8) or during an unscheduled or postoperative hospitalization (n = 11). The median duration of hospitalization for ventilator change was 2 days (interquartile range: 6 days) and generally 1 day for patients admitted solely for ventilator change.” The 19 patients were changed to either Breas Vivo 65 (Breas Medical AB, n = 13) or AstralTM 150 (ResMed, n = 6) based on ventilator availability with the patient’s DME company. According to the study, the recall was due to “problems related to the polyester‐based polyurethane sound abatement foam used in the affected devices that could generate particulate matter which may be inhaled or ingested by the user, and off‐gas potentially toxic carcinogenic chemicals. In the recall notice, Philips Respironics has reported patient complaints of black particles in the airpath circuit of the devices, cough, upper airway irritation, headache, chest pressure, and sinus infection. Philips Respironics reports potential risks of particulate and chemical exposure due to off‐gassing, including irritation of the skin, eye, and respiratory tract, headache, asthma, hypersensitivity, nausea, vomiting, and toxic carcinogenic effects. Although there have been no reported deaths due to these issues, the duration of exposure required to produce symptoms is unknown.” The American Academy of Sleep Medicine, American Thoracic Society, and Canadian Thoracic Society has provided guidance for physicians managing patients affected by the Philips recall. For patients using life‐sustaining ventilators, Philips Respironics and professional societies have recommended that patients not stop therapy until after talking to their physician.

“This recall has imposed a burden on pediatric clinicians and healthcare systems requiring notification of patients using affected ventilators, reviewing the risks and benefits of continued therapy, triaging children with higher medical acuity for ventilator replacement, and arranging for replacement unaffected ventilators during a summer surge in hospitalizations due to COVID‐19 and respiratory infections,” the authors write. In the study’s discussion section, the authors concluded that while limited by the single institution retrospective study design with a small sample size, a “collaborative approach” can optimize the transition to nonrecalled devices.

“Based on consensus within our pediatric pulmonology division, this institutional protocol was formulated to facilitate and prioritize ventilator transition in children using affected Trilogy ventilators,” they write. “Since children using PPV‐T are often medically complex and fragile compared to adults, we elected to perform ventilator changes in the inpatient setting where children could be closely monitored and appropriate changes in ventilator settings could be performed, if required. A study on bench evaluation of PHVs showed wide variability in performance and triggering sensitivity that may influence assisted ventilation delivery. Moreover, the inpatient setting also permitted parental caregivers' training on using their new non‐recalled PHV. Patients who were already hospitalized, scheduled for an elective postoperative hospitalization, or reported symptoms listed in the Philips Respironics recall statement were prioritized for inpatient ventilator change. Our ventilator change protocol relied heavily on patient‐centered shared decision‐making balancing the risks and benefits of using the recalled Trilogy ventilator and hospitalization to change ventilators. Moreover, close communication and collaboration with the parental caregivers, regional DME companies, hospital bed availability, outpatient and inpatient pulmonologists, and nurse coordinators were key aspects of our protocol. Some obstacles we encountered while implementing our protocol included intermittent shortages of PHVs with the DME companies that also had to service regional adult hospitals. Therefore, we obtained a weekly inventory of available non‐recalled PHVs from the DME companies to schedule hospitalizations and PHV changes for our patients. Another challenge was unavailability of inpatient beds due to surges in COVID‐19 and other respiratory infections requiring hospitalization during the study period. Therefore, we prioritized ventilator changes in patients who were already hospitalized and hospitalizations for elective ventilator changes were scheduled when beds became available. Although the ventilator change was accomplished during a brief hospitalization in this study, we acknowledge that some parental caregivers may require additional time for ventilator training.”

Webinar Tackles Smoking Habits

NOV 2 2021

The American Lung Association in Kansas and Greater Kansas City will host a lunch and learn webinar, sponsored by Vitalograph, on Wednesday, November 17 at 12:00 p.m. The free virtual event, which takes place one day before the Great American Smokeout (an annual nationwide campaign to quit smoking), will educate health care providers, respiratory therapists, asthma educators and nurses on ways to guide patients as they begin a new, smokefree phase of their lives. Featured will be Albert Rizzo, MD, FACP, FCCP, Chief Medical Officer (CMO) of the American Lung Association. Dr Rizzo is a key medical advisor to the Lung Association, member of the Lung Cancer Expert Medical Advisory Panel and leading media spokesperson for the Lung Association. He plays a key role in multiple areas of the Lung Association’s mission, including its Lung HelpLine, research, advocacy, communications, development and health promotions. Participants will have an opportunity to earn one Continuing Respiratory Care Education (CRCE) credit by the American Association for Respiratory Care. You can sign up here. Signup Form (

Masimo Launches Dual SET Pulse Oximetry

NOV 1 2021

Masimo announced Dual SET Pulse Oximetry for Root, a highly versatile patient monitoring and connectivity hub. The first application of Dual SET Oximetry is a significant advancement to Masimo SET-guided critical congenital heart disease (CCHD) screening, with the CE marking and European launch of the Masimo SET MOC-9 module and the addition of the Eve CCHD Newborn Screening Application for Root. Together, this combined solution enhances the automation of newborn screenings using Dual SET Oximetry: two simultaneous measurements of oxygen saturation (SpO2) at pre- and post-ductal sites by the intuitive Eve application, customized to align with a hospital’s CCHD screening protocol. CCHD affects approximately 2.5 to 3 newborns per 1000 live births and requires intervention soon after birth to prevent significant morbidity or mortality; later detection in infants also increases the risk of brain damage. Traditionally, newborns were observed for evidence of CCHD by physical assessment and monitoring for common symptoms, but studies have shown that physical assessment of newborns alone can be unreliable and may fail to detect some infants with CCHD before discharge. Adding screening with pulse oximetry can help clinicians identify CCHD before an infant becomes symptomatic. Clinically proven Masimo SET Measure-through Motion and Low Perfusion pulse oximetry has been shown in more than 10 CCHD screening studies – representing over 300,000 babies – to increase the effectiveness of screening newborns for CCHD. For example, in a study of almost 40,000 infants, CCHD screening sensitivity increased from 63% with physical exam alone to 83% with physical exam and SET. In another study of more than 120,000 infants – the largest CCHD screening study to date – combined use of clinical assessment and SET increased screening sensitivity from 77% to 93%. Evidence from CCHD studies using SET has even been used to help establish CCHD screening guidelines used around the world. Powered by Masimo SET pulse oximetry, the Eve CCHD Newborn Screening Application is designed to simplify the CCHD screening process by providing step-by-step visual instructions, animations, and a detailed, easy-to-interpret display of screening results – standardizing and enhancing clinical workflows, improving consistency in screening practices among clinicians, and reducing the possibility of calculation errors. Eve also allows clinicians to incorporate perfusion index into screening, which has been shown to increase sensitivity to the detection of CCHD. Already available for Radical-7 and Rad-97 Pulse CO-Oximeters, Eve is particularly well suited for display on Root’s large, high-resolution screen. With its built-in barcode scanner, Root can automatically associate patients with their screening results, and with its integration into the Masimo Hospital Automation platform, Root automates the transfer of those results to electronic medical records (EMRs) – eliminating the need for manual charting. Now, with the addition of the new Masimo SET MOC-9 module for Root – made possible by another key differentiator of the hub, its advanced, flexible connectivity capabilities – CCHD screening guided by Eve is even more streamlined and efficient: one pulse oximetry sensor can be connected to Root via Radical-7, and a second via the MOC-9 module, allowing for the pre- and post-ductal SpO2 readings needed for screening to be taken simultaneously rather than sequentially, with results conveniently displayed on one screen. This Dual SET Oximetry technique streamlines the CCHD screening process, improving clinical workflows. Gerard R. Martin, MD, C.R. Beyda Professor of Cardiology at Children’s National Hospital, said, “As an advocate for congenital heart disease efforts nationally and internationally, I believe Masimo SET pulse oximetry is an excellent tool for pulse oximetry CCHD screening. Having access to accurate simultaneous pre-ductal and post-ductal measurements helps simplify the process of screening and allows for rapid recognition of discrepancies, ultimately improving newborn care.” Root is a powerful, expandable hub that integrates an array of technologies, devices, and systems to provide centralized, multimodal monitoring and connectivity solutions. Root’s plug-and-play expansion capabilities allow clinicians to simultaneously monitor with numerous measurements in addition to dual oximetry Masimo SET, such as advanced rainbow Pulse CO-Oximetry measurements, O3 regional oximetry, and SedLine brain function monitoring, for expanded visibility of patient status. Using Root in combination with the Hospital Automation platform, monitoring data from all connected devices can be automatically charted in EMRs. Augusto Sola, MD, Vice President of Medical Affairs at Masimo, commented, “As a neonatologist who has worked nationally and internationally in the early diagnosis and treatment of hypoxemic and hyperoxemic conditions that affect neonates in order to improve neonatal survival and quality of life for these fragile infants, I know that Masimo SET measure-through motion technology’s accuracy and reliability have not only enabled CCHD screening with pulse oximetry, but have helped dramatically reduce retinopathy of prematurity (ROP). SET provides reliable, high-quality monitoring to prevent serious long-term morbidities and is now the standard of care for CCHD newborn screenings and ROP. With the availability of the SET MOC-9 Module, clinicians can now obtain simultaneous, dual oximetry pre- and post- ductal measurements, using one display, and increase efficiency of CCHD newborn screenings with Root. Furthermore, the Eve application on Root is automated and therefore simplifies and systematizes the screening process. Millions of newborn babies and their families throughout the world will be greatly benefited by this unique solution.”

NDD Welcomes Michael Bencak as New CEO

OCT 21 2021

NDD Medical Technologies (NDD), a global leader and innovator of diagnostic devices for the early detection of COPD and other chronic lung diseases, announced the appointment of Michael Bencak as Chief Executive Officer. Michael has two decades of experience in the medical device and biotechnology industry, including most recently at BEKA Scientific GmbH and Zinsser Analytic GmbH as Chief Executive Officer, where he repeatedly produced sustained revenue and Earnings Before Interest and Taxes (EBIT) growth in dynamic and evolving markets. Michael joins NDD at an exciting time, with the company exhibiting rapid growth due to the increasing demand for spirometry and DLCO devices. NDD was founded by Professor Karl Harnoncourt and Dr. Christian Buess, now Chief Technology Officer, after identifying an urgent need for advancements in pulmonary testing. With consistent growth throughout their 25-year history, NDD is the global leader in lung function testing and pulmonary function test devices, with innovative devices such as the EasyOne® product line providing much-needed point-of-care solutions. Committed to improving the lives of patients with the early detection and diagnosis of COPD and other chronic lung diseases, at a time of accelerating demand for additional lung testing due to long-Covid, NDD prides itself on the development of new and innovative solutions. Former CEO and now Chief Strategy Officer, Georg Harnoncourt, said “NDD has provided innovative lung function testing devices since 1996, with the mission of helping physicians around the world to rapidly identify and diagnose respiratory disease. We are excited to welcome Michael to the NDD family. His exemplary leadership track record, a wealth of medical technology experience and proven ability to drive results, makes him the right leader to build on NDD’s heritage and steer our future development at this pivotal time of expanding innovation.” Commenting on his new appointment as CEO, Michael Bencak says “I am delighted to join NDD. The business has a fantastic team and I feel honored to be able to build on the great foundations and innovative culture fostered by Georg and Christian. I am committed to the core values of our company and look forward to working closely with our exceptional team to accelerate innovation at this critical phase. Though global healthcare has always focused on the problem of emerging infections, the last 18 months have demonstrated that companies like NDD, who strive to not only be proactive but also reactive, are crucial to help build a better, more patient-oriented world.”

Life Supporting Ventilator with High-Flow Oxygen Therapy Gets Commercial Launch

OCT 12 2021

Movair, a respiratory therapy company formerly known as International Biophysics Corporation, announced the US commercial launch of Luisa, an advanced ventilator intended for use in homes, institutions, hospitals or portable applications for both invasive and non-invasive ventilation. Luisa can be used through the FDA's Emergency Use Authorization* in response to the increasing need for safe and effective ventilators. Luisa is a portable and compact home ventilator now available in the US and one of the first with the added benefit of high-flow oxygen therapy. For patients with chronic and acute respiratory conditions that require long-term ventilation, prolonged compliance is critical. Luisa was designed to help patients embrace everyday experiences and active, mobile lifestyles. Weighing only eight pounds, Luisa includes a battery run time of up to 18 hours and offers patients eight adjustable comfort settings to deliver personalized, tailored therapy. Luisa also features a rotatable 10-inch display and flexible connectivity options so patients can integrate the ventilator into current lifestyle habits such as sleeping on a certain side of the bed. Additionally, Luisa can be programmed in multiple languages, ensuring a multitude of diverse patients, families and caregivers receive understandable alarm notifications. "Life supporting ventilation with high-flow therapy using the Luisa device proved to be a true asset during the most recent COVID-19 surge," said Rami Arfoosh, MD, FCCP, Pulmonary and Critical Care Specialist and Associate Professor of Medicine at Medical College of Georgia, AU/UGA Medical Partnership. "It provided a new option to meet the high-flow needs for some patients in their home environment. Those patients would have otherwise continued to occupy hospital beds because of the lack of equipment that meets their needs at home. Luisa also provides the unique feature of switching back and forth between high-flow nasal cannula (HFNC) and non-invasive ventilator (NIV) with different mode by the push of a button." Luisa provides respiratory support and utilizes all standard volume, pressure and mouthpiece ventilation modes with the added benefit of high-flow oxygen therapy that can support nocturnally ventilated patients during the day with a less intrusive nasal cannula. High-flow oxygen therapy delivers a blend of air and oxygen that meets or exceeds a patient's inspiratory flow demand to improve oxygenation and decrease the workload of breathing. "Increased respiratory patient illness, COVID-19 and product recalls have created a critical need for ventilators in the United States," said David Shockley, CEO of Movair. "We're addressing this demand with the launch of Luisa, a portable and compact home ventilator, designed and made in Germany that also provides patients with high-flow oxygen therapy. At Movair, we're committed to advancing life-empowering respiratory therapies that help patients breathe better and live better. The launch of Luisa underscores this commitment." Luisa is the third-generation ventilator developed and manufactured by Lowenstein Medical in Germany, and marketed in Europe since 2020. It can be prescribed to patients diagnosed with chronic respiratory failure due to chronic obstructive pulmonary disease (COPD) and interstitial lung disease (ILD) dependent on meeting certain qualifications. Luisa can provide high-flow therapy to patients that need at-home ventilation and also offers FIO₂ and SPO₂ monitoring and ventilation from 100 ml VT. Movair is the exclusive US dealer for Lowenstein Medical. While Luisa can be purchased through various durable medical equipment (DME) providers, normally it is provided to patients by these DMEs through private or government health insurance. In August, Movair began pre-marketing Luisa, which is already being used by thousands of patients in the US. Many of these patients are recovering post-COVID and were transitioned home with Luisa.

New Non-invasive Ventilator Launched

OCT 12 2021

To meet the need for safe, effective and reliable non-invasive ventilation (NIV) throughout the care continuum, Dräger has launched the new Savina 300 NIV, the latest ventilator in its Savina 300 family of ventilators. Built to Dräger’s exceptionally high standards and backed by its 100+ years of experience in mechanical ventilation, the Savina 300 NIV features automatic leakage compensation to deliver consistent prescribed settings when faced with patient interface leaks. Its built-in turbine with rapid response time and external battery allows operation independent from the central gas supply to facilitate care continuity during patient transfers. “Both acute and alternative care facilities rely on Dräger for the latest innovations in respiratory care delivered with integrity and dependability,” said Steve Menet, Dräger’s senior vice president of sales, hospital solutions. “Breathing is essential to life so for patients with respiratory challenges any disruptions in the effectiveness of non-invasive ventilation can jeopardize outcomes. With the launch of Savina 300 NIV, we are meeting clinician and patient demand for consistent and safe non-invasive mechanical ventilation in both acute and chronic care facilities.” To help support patient comfort during NIV therapy, the Savina 300 NIV is compatible for use with the FitStar disposable mask, which features gel cushion technology to help reduce complications such as pressure points and skin irritation. Available in four sizes, FitStar’s simple and breatheable headgear has a continuous range of adjustment to offer a custom fit while removing pressure from the bridge of the nose. The mask’s 360 degree rotating elbow facilitates optimal tube positioning and ease of mobility, while its quick-release headgear slides off easily with one hand.

Company Appoints New President

Oct 1 2021

3B Medical Inc, an innovative manufacturer and distributor of Sleep, Oxygen and Disinfection products announced the appointment of Tom Pontzius as President, 3B Medical, Inc. Tom has over 35 years of experience in healthcare manufacturing and distribution. Tom most recently served as leader of Industry Affairs and Business Development at Philips where he was employed for over 12 years in various leadership roles. Throughout his career Tom has held various roles supporting various customers from hospitals and skilled nursing facilities to home health care and home medical equipment providers. Tom’s experience in sales, marketing, operations, manufacturing, and distribution will be critical as 3B Medical Inc. continues to grow and innovate in the healthcare and consumer health areas. “Tom’s leadership, knowledge of the industry and strategic thinking will allow 3B Medical to continue to grow and achieve its objectives.” said Alex Lucio, founder of 3B Medical. “His patient and customer first approach align well with 3B Medical’s mission. Adding valuable knowledge around the chronic diseases and treatment along with his proven ability to build scale allows 3B Medical to continue to build on its fast-growing businesses. We look forward to Tom’s leadership in continuing to build a world-class organization.” “3B Medical has been a leading company in the industry and continues to innovate and offer solutions to meet the demands of patients and providers,” said Pontzius.“ The proven products, the people at the company and the goals and objectives of the company align with my experience and skills. I look forward to building upon an already solid business with the executive leadership team and the dedicated associates at 3B Medical.”

New Ceiling Supply Units Add Flexibility in Hospitals

Sep 30 2021

Dräger’s new Ambia and Ponta ceiling supply systems offer hospitals substantial flexibility in creating customized workstations that supports specific clinical needs in the operating room (OR), intensive care unit (ICU) and neonatal intensive care unit (NICU). The ceiling supply systems provide the ability to mount medical equipment and accessories on all four sides of the frame rail. This optimizes space, and allows equipment and accessories to be placed exactly where they are needed. Free positioning of a mix of electrical and gas outlets on all panels make it possible to place more outlets on a media column or head. The result, Ambia helps streamline workflow with the goal of increasing the satisfaction and safety of staff and patients – now and in the future. And with coordinated frame color selections and drawer decor variants, Ambia and Ponta can be easily integrated into any room concept, creating a patient-friendly environment. In addition, lighting options featuring warm, glare-free light, along with the ability to select from a range of RGB colors, helping to contribute to a calming and soothing atmosphere. Ambia and Ponta feature intuitive user interfaces that support quick and easy operation. The arm brake handles feature touch-sensitive sensors that automatically release the brakes, allowing rapid positioning of the media heads or columns. The brake handle locations on the units can also be adapted to suit individual staff or workflow requirements for ideal ergonomics. The handles communicate using wireless technology, allowing them to be located almost anywhere on the system. For infection protection, rounded profiles and smooth materials that are compatible with a wide range of disinfection products help make the Ambia and Ponta easy and fast to clean and disinfect. A range of cable management options help eliminate cord clutter and assist with reducing exposed surface area and the accumulation of dirt. A touchless user control for operating ceiling and floor lights further supports infection prevention efforts. Dräger has more than 60 years of consulting experience in the design of medical workplaces, including the analysis of work processes and space requirements, consulting for optimized workflows and digitally supported room concept creation, and on-site equipment implementation.

Free Webinar: Challenges of Medication Applications

Sep 29 2021

Vitalograph (USA) Inc. is sponsoring another “Lunch and Learn webinar series” Challenges of Medication Application. This webinar is for health care providers, respiratory therapists, asthma educators, and nurses: Join in on Wednesday, Oct. 13, 2021, at 12:00 p.m. CDST, presented by Lorene Alba, AE-C, Director of Education for Asthma and Allergy Foundation of America. The goal of this program is to help you understand: How to properly use asthma devices; how to determine the best asthma delivery device; how to incorporate health literacy into all your resources; how to use the teach-back method. This program is pending for 1.0 contact hours of Continuing Respiratory Care Education (CRCE) credits by the American Association for Respiratory Care. Register here-

Medical Tech Company Buys Afflovest

Sep 29 2021

Tactile Systems Technology, Inc., a medical technology company focused on developing medical devices for the treatment of underserved chronic diseases at home, announced it has acquired the assets of the AffloVest respiratory therapy business from International Biophysics Corporation, a privately-held company which developed and manufactures AffloVest. AffloVest is a portable, wearable vest that treats patients with chronic respiratory conditions such as COPD-associated breathing conditions like bronchiectasis, or conditions resulting from neuromuscular disorders and cystic fibrosis, by managing airway clearance. AffloVest is the first truly portable, battery-powered, High Frequency Chest Wall Oscillation (HFCWO) device. Its use has been shown to reduce antibiotic use, emergency room visits and hospitalizations. “The addition of AffloVest represents an ideal strategic fit for Tactile Medical as it aligns well with our focus of treating patients with underserved chronic conditions in the home,” said Dan Reuvers, President and CEO of Tactile Medical. “We expect to promote AffloVest’s patented, portable design, demonstrated clinical outcomes, and established reimbursement within the Durable Medical Equipment (DME) channel to drive AffloVest to contribute to our overall company goal of 20%+ revenue growth going forward. Like lymphedema, the chronic pulmonary disease market represents a large, and still underpenetrated opportunity. Importantly, multiple members of our management team have significant experience in this category, which gives us confidence in our ability to execute our commercial strategy for AffloVest. We look forward to welcoming the AffloVest sales team to Tactile Medical and intend to maintain their strategy of partnering with DME companies to promote the proven therapy. The sales representatives at these DME companies are uniquely positioned to provide valuable access to chronic respiratory providers and patients through their complementary product and service offerings such as oxygen, nebulizers and ventilators.” Reuvers continued, “Longer term, we believe adding a mobile, wearable therapy to our portfolio invites synergy within our R&D roadmap as we advance our goals within ease-of-use and digital engagement. We believe this is a compelling transaction as it expands Tactile Medical’s annual addressable market opportunity in the U.S. to more than $10 billion, fits our long-term revenue and margin growth profile, enhances our long-term profitability, and is expected to generate an attractive return on investment.” Tactile Medical has financed the transaction through a combination of cash on hand and $55 million of borrowings under its existing credit facility, which is being amended in connection with this transaction. The credit facility is being exclusively provided by Wells Fargo Bank, NA. Tactile Medical expects its net leverage ratio as of year-end 2021 to be approximately 1.4x and anticipates its net leverage ratio as of year-end 2022 to be less than 1.0x.

CDC Says COVID, Flu Vaccines Can Be Co-Administered

Sep 27 2021

When the Centers for Disease Control and Prevention (CDC) released its latest round of recommendations regarding seasonal influenza vaccines, the document contained one notable update: flu vaccines and COVID-19 vaccines can now be given simultaneously.
This change stands in marked contrast to previous recommendations, in which the CDC said that other vaccinations should not be administered within a 2-week window before or after receiving the COVID-19 vaccine. "We believe flu vaccination is very important in the context of ongoing COVID-19 activity," said Lisa A. Grohskopf, MD, MPH, medical officer, Influenza Division, CDC, in an interview. "First, as COVID-19 cases continue to increase, our healthcare system is increasingly burdened by caring for COVID-19 patients. While flu activity has been unusually low since March of 2020, we are seeing the return of other common respiratory viruses, so we anticipate that we will experience an annual epidemic of flu this season as we do during most winters. "Substantial flu activity occurring at the same time as COVID-19 activity could overwhelm our healthcare systems," she added. Grohskopf explained that the current recommendations ― the product of regular meetings of the Advisory Committee on Immunization Practices' (ACIP's) Influenza Working Group — are intended to guide clinicians in the use of influenza vaccines for the upcoming flu season, from late fall through early spring. Not surprisingly, they recommend routine annual influenza vaccination for all people who are at least 6 months of age and who do not have contraindications. Following such precautions will not only reduce the prevalence of illness caused by influenza but will also reduce symptoms that might be confused with those of COVID-19, the authors say. In addition, preventing flu and mitigating the severity of its symptoms will likely result in a reduction of outpatient visits, hospitalizations, and intensive care unit admissions, which in turn may alleviate stresses on the healthcare system caused by COVID-19. "ACIP and CDC's universal flu vaccine recommendation has not changed," Grohskopf noted. "Everyone 6 months of age and older should get a flu vaccine every season, with rare exception. There are some groups of people who are at higher risk of developing severe flu complications, and vaccination is especially important for them. This includes adults 65 years and older, people with certain chronic health conditions (for example, asthma, diabetes, heart disease), pregnant people, and children younger than 5 years old." In addition to the timing of COVID-19 vaccinations, the recommendations have other notable updates. First, the composition of flu vaccines has been updated such that all vaccines are now quadrivalent, designed to protect against four flu viruses. Additionally, licensure for the Flucelvax Quadrivalent flu vaccine has changed: the approved age indication for the cell culture–based inactivated vaccine has been increased from age 4 years or older to age 2 years or older.

Circadian System Implicated in Asthma Worsening at Night

Sep 27 2021

For hundreds of years, people have observed that asthma severity often worsens in the nighttime. One longstanding question has been to what degree the body's internal circadian clock -- as opposed to behaviors, such as sleep and physical activities -- contributes to worsening of asthma severity. Using two circadian protocols, investigators from Brigham and Women's Hospital and Oregon Health & Science University have pinned down the influence of the circadian system, uncovering a key role for the biological clock in asthma. Understanding the mechanisms that influence asthma severity could have important implications for both studying and treating asthma. Results are published in The Proceedings of the National Academy of Sciences. "This is one of the first studies to carefully isolate the influence of the circadian system from the other factors that are behavioral and environmental, including sleep," said co-corresponding author Frank A.J.L. Scheer, PhD, MSc, director of the Medical Chronobiology Program in the Division of Sleep and Circadian Disorders at the Brigham. Co-corresponding author Steven A. Shea, PhD, professor and director at Oregon Institute of Occupational Health Sciences added, "We observed that those people who have the worst asthma in general are the ones who suffer from the greatest circadian-induced drops in pulmonary function at night, and also had the greatest changes induced by behaviors, including sleep. We also found that these results are clinically important because, when studied in the laboratory, symptom-driven bronchodilator inhaler use was as much as four times more often during the circadian night than during the day." As many as 75 percent of people with asthma -- 20 million people in the U.S. -- report experiencing worsening asthma severity at night. Many behavioral and environmental factors, including exercise, air temperature, posture, and sleep environment, are known to influence asthma severity. Scheer, Shea, and colleagues wanted to understand the contributions of the internal circadian system to this problem. The circadian system is composed of a central pacemaker in the brain (the suprachiasmatic nucleus) and "clocks" throughout the body and is critical for the coordination of bodily functions and to anticipate the daily cycling environmental and behavioral demands. To disentangle the influence of the circadian system from that of sleep and other behavioral and environmental factors, the researchers enrolled 17 participants with asthma (who were not talking steroid medication, but who did use bronchodilator inhalers whenever they felt asthma symptoms were worsening) into two complementary laboratory protocols where lung function, asthma symptoms and bronchodilator use were continuously assessed. In the "constant routine" protocol, participants spent 38 hours continuously awake, in a constant posture, and under dim light conditions, with identical snacks every two hours. In the "forced desynchrony" protocol, participants were placed on a recurring 28-hour sleep/wake cycle for a week under dim light conditions, with all behaviors scheduled evenly across the cycle.

Company Expands Facility

Sep 27 2021

Siemens Healthineers announced it will invest more than $32 million in its Glasgow Laboratory Diagnostics Manufacturing Facility located in Newark, Delaware. The investment extends over 24 months and will enable the company to position in Delaware manufacturing capabilities for more than 20 diagnostic tests. This project is part of an initiative to drive greater efficiency, productivity, and stability across the company's diagnostics supply chain. “The Glasgow manufacturing facility expansion will further increase our manufacturing footprint in the United States—the largest healthcare market in the world,” said Deepak Nath, PhD, President of Laboratory Diagnostics, Siemens Healthineers. “As part of the expansion, we will relocate important test manufacturing to this facility, which will streamline some of our processes and further improve the efficiency with which we can deliver these important tests to healthcare providers and their patients.” The Newark, DE facility employs more than 1,300 employees and manufactures more than 120 assays that run on certain instrument platforms, including the Atellica Solution, ADVIA Chemistry, Dimension, Dimension Vista, Syva Drug Testing, and Stratus CS instruments—providing tests that help physicians diagnose, monitor, and/or treat diseases. The Glasgow manufacturing facility is one of several manufacturing facilities Siemens Healthineers operates for its diagnostics portfolio.

New Study Evaluates the Feasibility of Using Masimo EMMA Capnography on Mechanically Ventilated Neonates

Sep 27 2021

Masimo announced the findings of a study published in the European Journal of Pediatrics in which Dr. Masashi Hotta and colleagues at the Osaka Women’s and Children’s Hospital in Japan found that the Masimo EMMA Portable Capnograph “may be considered an effective monitoring device” for mechanically ventilated preterm infants (neonates). Noting the importance of maintaining an appropriate range of partial pressure of arterial carbon dioxide (PaCO2) in preterm infants, especially while undergoing mechanical ventilation in the neonatal intensive care unit (NICU), the researchers sought to evaluate whether noninvasively monitoring end-tidal carbon dioxide (EtCO2) with EMMA could help clinicians maintain neonatal PaCO2 in the delivery room. They chose EMMA not only because of its portability but because it offers a solution with a small dead space (1 mL). The researchers enrolled 40 neonates (gestational age of 26+0 to 31+6 weeks) who required intubation in the delivery room (the EMMA monitoring group) and compared their PaCO2 value, either at admission to the NICU or 2 hours after birth, with that of 43 infants who did not undergo EMMA monitoring (the historical control group). They defined “appropriate” PaCO2 as 35 – 60 mmHg, as measured using a blood gas analyzer. The researchers found that the proportion of infants with appropriate PaCO2 was greater in the EMMA group than in the control group (80% vs. 42%, p = 0.001). Stratified according to birth weight (< 1000 g vs. > 1000 g), they found that in smaller neonates, there was no significant difference in the proportion of infants with appropriate PaCO2 between groups, but in the larger cohort, the rate of appropriate PaCO2 was significantly higher in the EMMA group: 93% vs. 44%, p < 0.001. The study authors concluded that EMMA “facilitated the maintenance of an appropriate PaCO2 for mechanically ventilated pre-term infants, especially infants with birth weight ≥ 1000 g, in the delivery room.” They noted that the main strength of their study was that they “collected intervention data prospectively and showed the feasibility of using a portable capnometer during resuscitation of intubated preterm infants” – the first study of its kind. EMMA provides seamless mainstream capnography for patients of all ages in a compact, easily portable device. The instrument requires no routine calibration and minimal warm-up time, with accurate EtCO2 and respiration rate measurements and continuous EtCO2 waveforms displayed within 15 seconds.

Masimo CEO Joe Kiani Appointed to President’s Council of Advisors on Science and Technology

Sep 22 2021

Masimo announced that Founder, Chairman, and CEO Joe Kiani has been appointed by President Joe Biden to the President’s Council of Advisors on Science and Technology (PCAST). Since 1933, with the creation by President Franklin D. Roosevelt of a Science Advisory Board, each President has established an advisory committee of scientists, engineers, and health professionals. Created by Executive Order, President Biden’s PCAST will advise him on matters involving science, technology, education, and innovation policy. The Council also provides the President with scientific and technical information needed to inform public policy relating to the American economy, the American worker, national and homeland security, and more. In particular, President Biden has asked PCAST to consider such pressing topics as how the pandemic can inform public health needs and how scientific and technological breakthroughs can help address climate change. The 30 members of the Council, the most diverse in history, include distinguished individuals from sectors outside the Federal Government with diverse perspectives and expertise in science, technology, education, and innovation, including 20 elected members of the National Academies of Sciences, Engineering and Medicine, five MacArthur “Genius” Fellows, two former Cabinet secretaries, and two Nobel laureates. Joe Kiani commented, “Thank you, President Biden, for this appointment. I am excited to work with this incredible PCAST group and others to explore ways that science and technology, and policies that can shape them, can improve healthcare, the environment, innovation, and equity in our country and the world.”

Patients With More Severe PH in COPD May Respond to Treatment

Sep 15 2021

Patients with pulmonary hypertension (PH) as a complication of chronic obstructive pulmonary disease (COPD) have worse functional impairment and higher mortality, compared with patients who have idiopathic pulmonary arterial hypertension (IPAH). Despite these factors, some patients with more severe PH in COPD may respond to treatment and show clinical improvement after treatment, according to recent research published in the journal CHEST Carmine Dario Vizza, MD, of the pulmonary hypertension unit, department of cardiovascular and respiratory diseases at Sapienza University of Rome, and colleagues evaluated patients in the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA) database, enrolled up to August 2020, identifying 68 patients with moderate PH and COPD and 307 patients with severe PH and COPD. The researchers compared the PH and COPD groups with 307 patients who had idiopathic pulmonary arterial hypertension. Overall, mostly older men made up the group of patients with moderate (50%; mean, 68.5 years) and severe PH in COPD (61%; mean 68.4 years), compared with those who had IPAH (37%; mean 61.7 years. Oral monotherapy for patients with PH and COPD was the main treatment, consisting of phosphodiesterase-5 inhibitors, while most patients with IPAH received endothelin receptor antagonists. On functional tests, patients in the PH and COPD group tended to perform poorer on the 6-minute walking distance (6MWD) and World Health Organization functional class (WHO FC) than patients with IPAH. Specifically, among 42.7% of patients in both group for whom follow-up data were available, there was a similar frequency of improvement for 6MWD of 30 meters or more from baseline for both PH and COPD and IPAH groups (46.9% vs. 52.6%; P = .294), but there were significant differences between 6MWD between patients with moderate and severe PH and COPD (51.6% vs. 31.6%; P = .04). There was a nonsignificant improvement in WHO FC improvement of one or more classes for 65.6% of patients with PH and COPD and 58.3% of patients with IPAH with follow-up data available, with 28.5% of patients with PH in COPD improving compared with 35.8% of patients with IPAH (P = .078) and nonsignificant differences between moderate and severe PH and COPD (19.0% vs. 30.4%; P = .188). Follow-up data were available for 84% of patients with IPAH and 94% of patients with PH and COPD. Dr. Dario Vizza and colleagues found 45.7% of patients in the PH and COPD group and 24.9% of patients in the IPAH group died during follow-up, while 1.1% in the PH and COPD group and 1.5% of patients in the IPAH group underwent lung transplantations. For patients with moderate PH and COPD, 31.3% died and none underwent lung transplantation, while 49.0% of patients in the severe PH and COPD group died and 1.4% underwent lung transplantations.

Obese Children With Asthma Are Resistant to ICS

Sep 15 2021

Obese or overweight children with asthma could be using inhaled corticosteroids (ICS) to no avail, combined results from observational studies suggest. Using Mendelian randomization, a method for reducing bias in observational studies, investigators from the University of Amsterdam Medical Center performed an analysis of data from four cross-sectional studies and one cohort study on a total of 1,511 children with asthma. They showed that every 1-unit increase in the body mass index (BMI) z score was associated with a more than twofold higher odds ratio for exacerbation, reported Cristina Longo, PhD, a former postdoctoral fellow at AMC, and assistant professor of medicine at the University of Montreal. “In this large, multicenter Mendelian randomization study, our findings support current evidence that children with higher BMI status respond inadequately to inhaled corticosteroids, and that this association is likely not explained by measured confounding or reverse causation,” she said in an oral abstract presentation during the European Respiratory Society International Congress. The obese-asthma phenotype in children is characterized by reduced lung function, high symptom expression, poor response to ICS, and high health care utilization. “While most observational studies suggest that weight status is associated with asthma exacerbations, despite using inhaled corticosteroids, it’s unclear whether these associations may be due to unmeasured confounding or reverse causation, which captures the idea that perhaps obesity is a consequence rather than a cause of uncontrolled severe asthma,” she said. Traditional observational studies of the obesity-asthma link rely on comparing data on asthma in a target population and comparing nonobese patients with obese patients. The problem with this method, Dr Longo contended, is that the exposure assignment – weight status – is not random, and could lead to bias from potential imbalance of confounders, leading to unintentionally biased results. In contrast, Mendelian randomization uses genetic data to approximate random assignment of exposures, using a risk score for BMI based on genetic susceptibility. The score is based on the accumulation of genetic variants (single-nucleotide polymorphisms, or SNPs) that predispose individuals to obesity, with higher numbers of variants results in a higher risk score. The scores are then used to determine the comparison groups for evaluating the obesity-asthma association.

Courageous RT Stories Told on Podcast

Sep 1 2021

Vitalograph (USA) Inc. has created a series of special editions for their Exhale podcast focused on the front lines of the great pandemic. The next several episodes we will be titled “Ask the Respiratory Therapist.” This special series will interview multiple Respiratory Therapists and PFT technicians in different healthcare situations caring for COVID-19 infected patients. They share their experiences with the public, what they endured during this pandemic, and what they expect of the future. The host of Exhale is Mark Russell, Marketing Communications Manager and Janson Lanier, National Sales Manager and Respiratory Therapist for Vitalograph US, a global leader in respiratory diagnostics. The most recent interview is with Kimberly Wins Koldoff a Respiratory Therapist working at a Medical Center outside of Atlanta, Georgia. Exhale connected with her when she posted on LinkedIn an emotional cry after a long shift and a plea to get vaccinated. Here’s her message: “My shifts this weekend confirmed my fears…Covid is indeed back. Today was one of the most exhausting days I’ve ever worked. I’m grieving. I’m angry. I’m scared. I’m tired. What can we do? Please consider getting vaccinated if you haven’t already.” These interviews of Respiratory Therapists and their colleagues on the frontlines say a lot about the pressure and the courage of the past 18 months. The days have been long, the breaks have been few, and the urgency has been unrelenting. The intent of these interviews is to shed some light of these medical heroes and what they endure day after day during the COVID pandemic. Vitalograph is a world-leading provider of the highest quality respiratory diagnostic devices, clinical trial services and medical equipment servicing. With a pioneering heritage of excellence spanning over half a century, Vitalograph continues to make valuable contributions to effective medical care and enhanced quality of life.

Long COVID Symptoms Can Persist for More Than 1 Year, Study Shows

Aug 30 2021

Nearly one half of people who are hospitalized with COVID-19 suffer at least one lingering symptom 1 year after discharge, according to the largest study yet to assess the dynamic recovery of a group of COVID-19 survivors 12 months after the illness. The most common lingering symptoms are fatigue and muscle weakness. One third continue to have shortness of breath. Overall, at 12 months, COVID-19 survivors had more problems with mobility, pain or discomfort, and anxiety or depression, and had lower self-assessment scores of quality of life than matched COVID-free peers, the investigators report. The study was published online August 26 in The Lancet.

"While most had made a good recovery, health problems persisted in some patients, especially those who had been critically ill during their hospital stay," Bin Cao, MD, from the National Center for Respiratory Medicine at the China-Japan Friendship Hospital and Capital Medical University, both in Beijing, said in a Lancet news release.

"Our findings suggest that recovery for some patients will take longer than one year, and this should be taken into account when planning delivery of healthcare services post-pandemic," Cao said.

Antidepressant Helps Prevent Hospitalization in COVID Patients: Study

Aug 30 2021

A handful of studies have suggested that for newly infected COVID-19 patients, risk for serious illness may be reduced with a short course of fluvoxamine (Luvox), a decades-old pill typically prescribed for depression or obsessive-compulsive disorder (OCD). But those were small studies involving just a few hundred people. Researchers reported promising data from a large, randomized phase 3 trial that enrolled COVID-19 patients from 11 sites in Brazil. In this study, in which 1472 people were assigned to receive either a 10-day course of fluvoxamine or placebo pills, the antidepressant cut emergency department and hospital admissions by 29%. Findings from the new study, which have not yet been peer reviewed, were published August 23 in MedRxiv. Around the globe, particularly in countries without access to vaccines, "treatment options that are cheap and available and supported by good-quality evidence are the only hope we've got to reduce mortality within high-risk populations," said Edward Mills, PhD, professor in the Department of Health Research Methods, Evidence and Impact, McMaster University, Ontario, Canada.

The new findings came from TOGETHER, a large platform trial coordinated by Mills and colleagues to evaluate the use of fluvoxamine and other repurposed drug candidates for symptomatic, high-risk, adult outpatients with confirmed cases of COVID-19. The trial's adaptive format allows multiple agents to be added and tested alongside placebo in a single master protocol — similar to the United Kingdom's Recovery trial, which found that the common steroid dexamethasone could reduce deaths among hospitalized COVID-19 patients. In platform trials, treatment arms can be dropped for futility, as was the case with hydroxychloroquine and lopinavir-ritonavir, neither of which did better than placebo at preventing hospitalization in an earlier TOGETHER trial analysis.

Children's Upper Airways Primed to Combat SARS-CoV-2 Infection

Aug 30 2021

Epithelial and immune cells of the upper airways of children are pre-activated and primed to detect a COVID-19 infection, which may contribute to a stronger early immune responses to a COVID infection than in adults, new research suggests. The findings may help to explain why children have a lower risk of developing severe COVID-19 illness or becoming infected with SARS-CoV-2, the novel coronavirus, in the first place, the researchers say. The study was published online August 18 in Nature Biotechnology Children appear to be better able than adults to control SARS-CoV-2 infection, but, until now, the exact molecular mechanisms for this have been unclear. A team of investigators from Germany did an in-depth analysis of nasal swab samples obtained from 24 children and 21 adults who tested positive for SARS-CoV-2, as well as a control group of 18 children and 23 adults who tested negative for SARS-CoV-2. “We wanted to understand why viral defense appears to work so much better in children than in adults,” Irina Lehmann, PhD, head of the molecular epidemiology unit at the Berlin Institute of Health Charité – Universitätsmedizin Berlin, explains in a news release. Single-cell sequencing showed that children had higher baseline levels of certain RNA-sensing receptors that are relevant to SARS-CoV-2 detection, such as MDA5 and RIG-I, in the epithelial and immune cells of their noses. This differential expression led to stronger early immune responses to SARS-CoV-2 infection in children than in adults. Children were also more likely than adults to possess distinct immune cell subpopulations, including KLRC1+ cytotoxic T cells, involved in fighting infection, and memory CD8+ T cells, associated with the development of long-lasting immunity. The study provides “clear evidence” that upper airway immune cells of children are “primed for virus sensing, resulting in a stronger early innate antiviral response to SARS-CoV-2 infection than in adults,” the investigators say. Primed virus sensing and a pre-activated innate immune response in children leads to efficient early production of interferons (IFNs) in the infected airways, likely mediating substantial antiviral effects, they note. Ultimately, this may lead to lower viral replication and faster clearance in children. In fact, several studies have already shown that children do eliminate the virus quicker than adults, consistent with the concept that they shut down viral replication earlier, the study team says.

EAACI Review Urges Reduction in Antibiotic Overuse With Allergy

Aug 30 2021

Urgent recommendations from a European Academy of Allergy and Clinical Immunology (EAACI) task force are aimed at reducing antibiotic overuse with allergic disease. Top recommendations include limiting antibiotic therapy in pregnancy and early childhood to help reduce the allergy epidemic in children, and restricting antibiotic therapy in exacerbations and chronic treatment of allergic diseases, especially asthma and atopic dermatitis. The review, by lead author Gerdien Tramper-Stranders, MD, PhD, Department of Pediatrics, Franciscus Gasthuis & Vlietland Hospital, Rotterdam, the Netherlands, and colleagues, was published online August 13 in the journal Allergy. The authors note that several studies have shown that use of antibiotics in childhood and during pregnancy is associated with disturbing the intestinal and respiratory microbiome, which in turn leads to dysbiosis and an increased risk of acquiring allergic diseases. In addition, patients with allergic diseases such as asthma have a higher risk of being prescribed antibiotics for infections compared with the general population, despite lack of clear clinical benefit. "In fact, there are no clear data supporting antibiotic prescriptions for acute exacerbations; and clinical and/or laboratory criteria are lacking," the authors write. Despite that lack of data, antibiotics are often prescribed for exacerbations along with oral corticosteroids, Tramper-Stranders told Medscape Medical News. Some patients may benefit from antibiotics in a flare-up, she said, but more research is needed to determine which ones. Tramper-Stranders said Franciscus has begun a large study that includes patients with asthma exacerbations to find biomarkers that might predict the type or origin of exacerbation to personalize treatment.

Patients With More Severe PH in COPD May Respond to Treatment

Aug 30 2021

Patients with pulmonary hypertension (PH) as a complication of chronic obstructive pulmonary disease (COPD) have worse functional impairment and higher mortality, compared with patients who have idiopathic pulmonary arterial hypertension (IPAH). Despite these factors, some patients with more severe PH in COPD may respond to treatment and show clinical improvement after treatment, according to recent research published in the journal CHEST. Carmine Dario Vizza, MD, of the pulmonary hypertension unit, department of cardiovascular and respiratory diseases at Sapienza University of Rome, and colleagues evaluated patients in the Comparative, Prospective Registry of Newly Initiated Therapies for Pulmonary Hypertension (COMPERA) database, enrolled up to August 2020, identifying 68 patients with moderate PH and COPD and 307 patients with severe PH and COPD. The researchers compared the PH and COPD groups with 307 patients who had idiopathic pulmonary arterial hypertension. Overall, mostly older men made up the group of patients with moderate (50%; mean, 68.5 years) and severe PH in COPD (61%; mean 68.4 years), compared with those who had IPAH (37%; mean 61.7 years. Oral monotherapy for patients with PH and COPD was the main treatment, consisting of phosphodiesterase-5 inhibitors, while most patients with IPAH received endothelin receptor antagonists. On functional tests, patients in the PH and COPD group tended to perform poorer on the 6-minute walking distance (6MWD) and World Health Organization functional class (WHO FC) than patients with IPAH. Specifically, among 42.7% of patients in both group for whom follow-up data were available, there was a similar frequency of improvement for 6MWD of 30 meters or more from baseline for both PH and COPD and IPAH groups (46.9% vs. 52.6%; P = .294), but there were significant differences between 6MWD between patients with moderate and severe PH and COPD (51.6% vs. 31.6%; P = .04). There was a nonsignificant improvement in WHO FC improvement of one or more classes for 65.6% of patients with PH and COPD and 58.3% of patients with IPAH with follow-up data available, with 28.5% of patients with PH in COPD improving compared with 35.8% of patients with IPAH (P = .078) and nonsignificant differences between moderate and severe PH and COPD (19.0% vs. 30.4%; P = .188).

AHA Targets Rising Prevalence of Obstructive Sleep Apnea in Children

Aug 30 2021

Obstructive sleep apnea is becoming more common in children and adolescents as the prevalence of obesity increases, but it may also be a preventable risk factor for cardiovascular disease, according to a new scientific statement from the American Heart Association. The statement focuses on the links between OSA and CVD risk factors in children and adolescents, and reviews diagnostic strategies and treatments. The writing committee reported that 1%-6% of children and adolescents have OSA, as do up to 60% of adolescents considered obese. The statement was created by the AHA’s Atherosclerosis, Hypertension, and Obesity in the Young subcommittee of the Council on Cardiovascular Disease in the Young and was published online in the Journal of the American Heart Association. Carissa M. Baker-Smith, MD, chair of the writing group chair and director of pediatric preventive cardiology at Nemours Cardiac Center, Alfred I. duPont Hospital for Children, Wilmington, Del., explained the rationale for issuing the statement at this time, noting that the relationship between OSA and CVD in adults is well documented. “There has been less focus on the importance of recognizing and treating sleep apnea in youth,” she said in an interview. “Thus, we felt that it was vitally important to get the word out to parents and to providers that paying attention to the quality and duration of your child’s sleep is vitally important to a child’s long-term heart health. Risk factors for heart disease, when present in childhood, can persist into adulthood.” For making the diagnosis of OSA in children, the statement provides clarity on the use of polysomnography and the role of the apnea-hypopnea index, which is lower in children with OSA than in adults. “One controversy, or at least as I saw it, was whether or not polysomnography testing is always required to make the diagnosis of OSA and before proceeding with tonsil and adenoid removal among children for whom enlarged tonsils and adenoids are present,” Dr Baker-Smith said. “Polysomnography testing is not always needed before an ear, nose, and throat surgeon may recommend surgery.” The statement also noted that history and physical examination may not yield enough reliable information to distinguish OSA from snoring. In areas where sleep laboratories that work with children aren’t available, alternative tests such as daytime nap polysomnography, nocturnal oximetry, and nocturnal video recording may be used – with a caveat. “These alternative tests have weaker positive and negative predictive values when compared with polysomnography,” the writing committee noted. Home sleep apnea tests aren’t recommended in children. Questionnaires “are useful as screening, but not as diagnostic tools.” Pediatric patients being evaluated for OSA should also be screened for hypertension and metabolic syndrome, as well as central nervous system and behavioral disorders. Diagnosing OSA in children and adolescents requires “a high index of suspicion,” the committee wrote. Pediatricians and pediatric cardiologists should exercise that high index of suspicion when receiving referrals for cardiac evaluations for attention deficit hyperactivity disorder medication, Dr. Baker-Smith said. “Take the time to ask about a child’s sleep – snoring, apnea, etc. – especially if the child has obesity, difficulty focusing during the day, and if there is evidence of systemic hypertension or other signs of metabolic syndrome,” she said.

Vapotherm Announces FDA Clearance for HVT 2.0 Next Generation Platform

Aug 30 2021

Vapotherm, Inc. announced it has received 510(k) clearance from the US Food and Drug Administration for HVT 2.0. This next generation system is designed to provide high velocity therapy using an integrated air source, eliminating the need for wall air or any pressurized air source. It is estimated that 50% of U.S. hospital beds don’t have wall air. When paired with an oxygen source, the HVT 2.0 will support patients whether they need respiratory support in the hospital or home setting. The Company is planning a limited commercial release of HVT 2.0 in the United States in the fourth quarter of 2021. “Clearance of HVT 2.0 enables us to provide high velocity therapy to Patients throughout the hospital, which is very important when ICU beds become scarce. It will allow hospitals to leverage their general care floors and potentially reduce emergency room crowding and wait times. We will also use this next generation platform, combined with the Vapotherm Access digital remote Patient monitoring platform, to begin learning how to treat complex lung disease Patients in the home,” said Joe Army, President and CEO of Vapotherm. Vapotherm, Inc. is a publicly traded developer and manufacturer of advanced respiratory technology based in Exeter, New Hampshire, USA. The company develops innovative, comfortable, non-invasive technologies for respiratory support of patients with chronic or acute breathing disorders. Vapotherm is focused on the development and commercialization of its proprietary Vapotherm high velocity therapy® products which are used to treat patients of all ages suffering from respiratory distress. Over 3.0 million patients have been treated with the use of Vapotherm high velocity therapy systems. For more information, visit

Masimo SafetyNet Alert Launches in Western Europe

Aug 30 2021

Masimo announced the CE marking and launch in western Europe of Masimo SafetyNet Alert, an arterial blood oxygen saturation monitoring and alert system designed for use at home. Masimo SafetyNet Alert features Signal Extraction Technology wearable fingertip pulse oximetry sensor that communicates wirelessly to an accompanying Home Medical Hub and smartphone app. Masimo SafetyNet Alert monitors blood oxygen saturation (SpO2) and pulse rate (PR) using clinically proven Masimo SET Measure-through Motion and Low Perfusion pulse oximetry and perfusion index (Pi). The system provides escalating alerts when drops in oxygen levels are detected, designed to wake up the person suffering from opioid overdose and if they do not, to send alerts to others when help may be needed. Over 200 million people are monitored with Masimo SET pulse oximetry in hospitals each year. In hospitals, continuous Masimo SET oxygen saturation monitoring has been shown to reduce harm associated with opioids in multiple clinical trials, including a 10-year study in which researchers at Dartmouth-Hitchcock Medical Center found that the use of Masimo SET-based continuous patient surveillance monitoring resulted in zero opioid-related preventable deaths or brain damage in their post-surgical wards. The researchers also found there was a reduction in rapid rescue events by 60%, a reduction in ICU transfers by 50%, and an estimated $7 million annually in cost savings. Opioids are powerful painkillers, and are commonly used as part of recovery after surgery and for patients with chronic pain, but they can also slow or stop one’s breathing, potentially leading to heart attack, brain damage, and even death. In 2020 the number of drug-related deaths recorded in England and Wales rose to 4,561, the highest since records began, and around half of these involved opioids.5 Worldwide, that number is even worse, with an estimated more than 100,000 people dying from opioid overdose each year. Whether taking prescription or non-prescription opioids, people can suffer from the condition known as opioid-induced respiratory depression (OIRD) to varying degrees.6 Opioid overdose may occur while a person is particularly vulnerable, while asleep, and the risk of opioid overdose-related death is heightened for people taking opioids for the first time, those who have sleep apnea, COPD, or asthma, along with those who combine opioids with alcohol or other sedatives, amongst other factors. By monitoring a person’s oxygen saturation level, especially while asleep, and providing escalating alerts when help may be needed, Masimo SafetyNet Alert can help identify life-threatening opioid overdose before it causes lasting harm or even death. Masimo SafetyNet Alert leverages the same SET pulse oximetry technology and a similar notification escalation policy used in hospitals to bring hospital-proven monitoring to the home setting. The system provides escalating visual and audible alerts on the smartphone app and at the Home Medical Hub station, which are designed to alert the patient or anyone nearby to help prompt action. If oxygen levels continue to decline, designated emergency contacts, such as friends and family members, are also notified via text messages, so that they can intervene or involve Emergency Medical Services as needed. Masimo SafetyNet Alert brings to the home the breakthrough Masimo SET pulse oximetry used in hospitals around the world. SET has been clinically proven to help care teams enhance patient safety and improve patient outcomes; in fact, more than 100 independent and objective studies have shown that Masimo SET outperforms other pulse oximetry technologies during motion and low perfusion conditions, providing clinicians with increased sensitivity and specificity to make critical care decisions. Dr Mike Durkin, a Senior NHS Advisor on Patient Safety Policy and Leadership for the National Institute for Health Research (NIHR) Imperial College Patient Safety Translational Research Centre, said, “Patients recovering from surgery still need pain relief using opioid drugs after they are discharged from hospital and return home. However, these drugs have significant side-effects, particularly on the depression of breathing, which without urgent intervention can result in serious harm or death. The technology is now available to monitor the impact of opioids on breathing and it is vital that patients are given the opportunity to easily and continuously monitor their oxygen levels and vital signs while taking these medications at home. This will greatly improve the safety of patients while rehabilitating at home.” Yvonne Gardner, mother of 21-year-old Parker Stewart, who died of an opioid overdose after taking only half of the prescribed dose of painkillers following a tonsillectomy, said, “I’ve had so many people call me personally and say, what would you do differently? My son needs a tonsillectomy, or my daughter is going into surgery. I tell them: make sure your doctor gives you a monitor.” Joe Kiani, Founder and CEO of Masimo, said, “30 years ago, we had the dream of improving patient outcomes and reducing the cost of care by taking noninvasive monitoring to new sites and applications. Bringing our measure-through motion and low perfusion pulse oximetry to the home to monitor patients taking opioids is fulfilling that dream in a way that I could not have imagined at the time. I hope tens of thousands of lives will be saved each year from opioid overdose with the launch of Masimo SafetyNet Alert.”

Study Shows Positive PVi Results

Aug 23 2021

Masimo announced the findings of a study published in the Turkish Journal of Emergency Medicine in which Drs Seda Dağar and Hüseyin Uzunosmanoğlu at the Kecioren Training and Research Hospital in Ankara, Turkey investigated the role that noninvasive, continuous Masimo PVi might play in monitoring volume status and volume changes in spontaneously breathing patients undergoing hemodialysis (HD). The researchers found that there was a “strong correlation” between change in PVi and the volume of fluid removed, concluding that “PVi may provide clinicians with useful information for monitoring the volume status in critically ill patients with spontaneous breathing.” More than 100 independent studies have demonstrated the utility of PVi as an indicator of fluid responsiveness. Noting that PVi has been studied mostly in mechanically ventilated patients, the researchers sought to investigate its ability to help assess volume changes in spontaneously breathing patients. They enrolled 60 adult patients with end-stage renal disease who received routine HD (during which fluid is removed simultaneously with the removal of waste solutes) and had a median of 3,500 cc of fluid removed during HD. PVi was measured using a Masimo pulse oximetry sensor attached to a Masimo Root monitor, before and after HD, and changes in PVi were compared to the amount of fluid removed during the session. The researchers found that mean PVi showed a statistically significant increase after HD, from 20.7% ± 5% to 27.7% ± 6% (p < 0.001). Based on the amount of fluid removed during HD, the change in PVi was statistically significant (p = 0.015) and was strongly correlated to the volume of fluid removed (r = 0.744, p < 0.001). The researchers concluded, “In the present study, we found that the fluid removed by HD in spontaneously breathing patients caused an increase in PVi and that this increase was strongly correlated with the amount of volume change. Bedside monitoring of PVi, which is a noninvasive, fast, reproducible measurement parameter, may provide the clinicians with useful information for monitoring the volume status and evaluating the effectiveness of volume‑restoration therapy in critically ill patients with spontaneous breathing.” The accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure, and device-related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient’s condition and should not be based solely on PVi. In the US, PVi is cleared as a noninvasive, dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients.

New Digital Features Available to Make Set Up Easier for Parents

Aug 17 2021

ResMed, a global leader in digital health and sleep apnea treatment, launched AirSense 11, available first in the US, the company’s next-generation PAP (positive airway pressure) device designed to help hundreds of millions of people worldwide with sleep apnea start and stay on therapy to treat and manage obstructive sleep apnea. AirSense 11 includes new features like Personal Therapy Assistant and Care Check-In designed to provide tailored guidance to PAP users, helping ease them into therapy and comfortable nightly use. Other features include the availability of remote software updates so users can enjoy the latest version of these tools every night. “AirSense 11’s new tailored features along with our myAir patient engagement app help give people the support they need to use PAP – the gold standard for treating sleep apnea – comfortably and confidently every night,” said Jim Hollingshead, ResMed president of Sleep and Respiratory Care. “And when digital health helps guide patients, it enables clinicians to provide great care to all their patients more efficiently.” AirSense 11 features include: Personal Therapy Assistant provides interactive step-by-step tutorials via the myAir app for patients to set up their device and acclimate to therapy pressure. Care Check-In gives patients tailored guidance through key milestones in their treatment journey, based on patients’ responses to simple questions like “How is your therapy” and “How sleepy did you feel this week?” It’s available in the myAir app and on the device screen itself. With the patient’s consent, healthcare providers can also see their patients’ responses in AirView, providing another fast, virtual way to monitor patients. A sleek design, touch screen, and intuitive menu mimic a smartphone, making it easy to use, designed to support increased adherence to therapy. ResMed’s proprietary therapy algorithms for AutoSet or APAP (auto-adjusting PAP) that delivers breath-by-breath therapy adjustments, the AutoSet for Her mode, a setting tailored to treat the female-specific characteristics of mild to moderate obstructive sleep apnea, and CPAP (continuous PAP). The ability to make over-the-air upgrades directly to a user’s device – just like you would get on a smartphone. AirSense 11 also gives access to myAir (patient engagement app) and AirView (remote monitoring platform for clinicians) – which together help bring overall patient adherence as high as 87%. The myAir app tracks the amount of time patients spend using CPAP therapy, number of sleep apnea events per hour, mask leak, and the number of times a mask was removed, providing nightly data on breathing, coaching tips, and support directly to their phone. AirView provides a secure, cloud-based patient management system for online patient monitoring that enables healthcare professionals to quickly access patient data, share clinical insights with other health professionals, improve care and reduce costs related to patient follow-up. AirSense 11 is available in the US, with other countries to follow, and is compatible with all ResMed masks. To learn more about AirSense 11, visit or speak with your healthcare provider.

Biologics for Asthma Also Improve Chronic Rhinosinusitis

Aug 13 2021

Biologics used as an asthma treatment also appear to improve symptoms of coexisting chronic rhinosinusitis in some patients, according to results from a real-world study published in the International Forum of Allergy & Rhinology. Although patients with asthma commonly have coexisting chronic rhinosinusitis (CRS) with nasal polyps (CRSwNP) or without nasal polyps (CRSsNP), research on the effect of biologics has focused on CRSwNP, according to Devyani Lal, MD, of the Department of Otolaryngology, Division of Rhinology, Mayo Clinic, Phoenix, Arizona, and colleagues. The researchers evaluated how the use of omalizumab, mepolizumab, benralizumab, reslizumab, and dupilumab affected a group of 181 patients with asthma and CRSwNP and 66 patients with asthma and CRSsNP in a retrospective review of electronic health records at the Mayo Clinic. Over a period of at least 12 months, most patients in the study received omalizumab (51%), mepolizumab (46.6%), benralizumab (10.5%) or a combination of omalizumab and mepolizumab (6.9%). Of the 247 patients studied, 206 (84.1%) underwent endoscopic sinus surgery (ESS) and 189 of those patients had the surgery performed prior to receiving biologic therapy. Matched-pair analyses were performed to identify changes from baseline in Lund-Mackay CT scores, SNOT-22 scores, serum eosinophil counts, and serum immunoglobulin E (IgE) levels. Lal and colleagues found treatment with an anti-interleukin-5 (anti-IL-5) biologic such as mepolizumab, benralizumab, or reslizumab significantly improved Lund-Mackay CT scores when analyzing the proportion of patients with both CRSwNP and CRSsNP, and SNOT-22 scores for patients with CRS overall and CRSwNP. Patients who received the anti-IgE biologic omalizumab had improved Lund-Mackay CT scores, but SNOT-22 scores did not significantly improve at any follow-up time, including the longest follow-up at mean 23.7 months. Aaron N. Pearlman, MD, an otolaryngologist at Weill Cornell Medicine and NewYork-Presbyterian in New York City, said the finding of objective and subjective improvement in a real-world study is important. "It shows you that these monoclonal antibodies are having a positive effect on diffuse chronic inflammatory conditions," said Pearlman, was not involved in the study. "Where asthma and chronic sinusitis with nasal polyps in many patients have a similar inflammatory pathway, we think that these medications would work on both systems. With this retrospective data, they've shown that there is some improvement even in patients [where] the indicated use was not for nasal polyps."

New Solution to Impact the Future of Respiratory Simulation

Aug 4 2021

IngMar Medical, LLC, a leading global provider of respiratory simulation solutions, launched their next generation solution for respiratory and ventilation training, RespiPro. With RespiPro, educators can train all levels of learners across multiple disciplines on the full scope of respiratory techniques using their own real ventilators and respiratory devices. The solution includes the most realistic breathing simulator, the ASL 5000, as well as easy-to-use software, a true-to-life patient monitor, and a respiratory-focused manikin on a compact ICU bed. IngMar Medical President, Brian Linn, explains, “We have spent years talking to customers about how we can help them achieve better training outcomes, ultimately leading to better patient care. We understand that our customers want to immerse their learners in an environment that is indistinguishable from real life, while controlling the simulation with easy-to-use software. These are the key elements of our new RespiPro, and that is why we are thrilled to share it with respiratory educators all over the world.” While the concept of RespiPro is the same as IngMar Medical’s legacy RespiSim System solutions, this launch is particularly monumental due to the overhaul of both the software and hardware components. IngMar Medical worked closely with educators throughout the entire development process to ensure RespiPro meets their respiratory and ventilation training needs. “The launch of RespiPro marks a major step on our journey, and we couldn’t be more excited to continue working with the respiratory simulation community to build off of this new foundation,” stated Linn.

CPAP Device is Available for Acute Care Use and Surge Capacity Planning

Aug 3 2021

The FDA issued recent guidelines indicating that Bilevel and CPAP devices can be used to effectively help treat COVID-19 patients in Respiratory Distress potentially avoiding mechanical ventilation. The patented Flow-Safe II+ is the first and only Disposable Bilevel CPAP ventilatory assist device available in the global market. This disposable Bilevel CPAP system includes a mask and manometer and optional filter that provides hospital and emergency clinicians with the components required to quickly set up the device and connect to an oxygen source for delivering verifiable Bilevel and CPAP therapies to patients in respiratory distress. A recent article published in the American Journal of Emergency Medicine supports the use of the Flow-Safe product line concluding, “The Flow-Safe Disposable CPAP system can be as effective as NIMV in patients with Acute Cardiogenic Pulmonary Oedema (ACPO). Considering the overall improvement observed in the physiological blood gas and other parameters as well as the mortality and cost-related considerations, FSD-CPAP-S can be preferred in emergency services if there are insufficient NIMV devices.” The disposable advantage reduces the need for costly capital equipment and is the clinical solution for situations where backup Bilevel / CPAP equipment is scarce or unavailable. Flow-Safe II+ has been used extensively in pre-hospital EMS environments and in acute care emergency rooms. The disposable feature has the added advantage of assisting in preventing potential cross contamination. These advantages make it an ideal solution when planning surge capacity for pandemics or natural disasters. Flow-Safe II+ was introduced to the market in 2018 and has been awarded two prestigious industry awards, the 2018 EMS World Innovation Award and the 2019 JEMS Hot Products Award. This novel device was selected for both awards from over hundreds of submissions after a thorough review by panel of judges consisting of emergency medical services (EMS) product specialists, physicians, educators, managers and paramedics. The United States Patent and Trademark Office (USPTO) has issued Flow-Safe II+ US Patent No.10,258,759 in 2019. In March 2020, the USPTO issued two new utility patents, US Patent No. 10,583,266 and 10,583,262 for the award-winning Flow-Safe II+ Disposable Bilevel CPAP device. John Gargaro MD, President and CEO at Mercury Medical, states: “Mercury Medical believes that Flow-Safe II+ is a unique superior solution designed to quickly improve patients in respiratory distress with a cost-efficient device. The disposable feature assists in reducing hospital infection rates that are associated with reusable equipment, Mercury Medical has a rich experience in introducing innovative, clinically differentiated medical devices to market. We are extremely pleased to extend this device to the acute care market where there is a need for Disposable Bilevel CPAP equipment.”

Benralizumab Promising for Severe, Chronic Rhinosinusitis With Nasal Polyps

Jul 30 2021

Benralizumab (Fasenra) significantly reduced nasal polyp score (NPS) and average nasal blockage score (NBS) compared with placebo for patients with severe chronic rhinosinusitis with nasal polyps (CRSwNP) in a phase 3 trial. The randomized, multicenter, double-blind, placebo-controlled OSTRO study, sponsored by AstraZeneca, enrolled 413 patients in Europe and North America with severe CRSwNP. The patients generally had high rates of comorbid asthma (68%); prior NP surgeries (73%); and elevated Sino-Nasal Outcome Test (SNOT-22) scores. They were randomly assigned in a 1:1 ratio to receive either benralizumab 30 mg or placebo. NPS and NBS (scored by patients from 0 [no blockage] to 3) were co-primary endpoints. Improvements in both were statistically significant compared with placebo at week 40 (P < .005). Improvements were maintained through week 56 (P < .05). Results were presented on July 11 at the European Academy of Allergy and Clinical Immunology (EAACI) Meeting 2021 by principal investigator Claus Bachert, MD, PhD, head of the Department of Oto-Rhino-Laryngology and chair of the Upper Airway Research Laboratory, University Hospital Ghent, Ghent, Belgium. He said, "It's clear that there is a significant difference from placebo." On the NPS, the difference from placebo was -0.57 (P = .0001) from week 40 to week 56. On the NBS, the difference from placebo was -0.27 (P = .005) at week 40. Patients with CRSwNP typically endure sleep disruptions, nasal congestion, loss of smell, and rhinorrhea, which lower physical and mental health-related quality of life. Current pharmacologic therapies, including intranasal and systemic corticosteroids, are often inadequate for managing symptoms, and symptoms frequently recur after surgery, he said. In the OSTRO trial, enhanced treatment effects were seen in some groups, including patients with comorbid asthma and/or higher baseline blood eosinophil counts.

Short-Acting Beta Agonist Overuse 'a Global Public Health Issue'

Jul 30 2021

About one third of asthma patients have high use of short-acting beta agonists (SABAs) in Europe across all severity levels, said Santiago Quirce, MD, PhD, with Hospital Universitario in Madrid, Spain. High use — defined as three or more canisters dispensed per year — "is a global public health issue," and is associated with increased risk of asthma exacerbations and death, he said, along with increased healthcare costs. Asthma patients tend to rely too heavily on SABAs and too little on inhaled corticosteroids (ICS), he said Saturday at the European Academy of Allergy and Clinical Immunology (EAACI) Hybrid Congress 2021, adding that SABA use continues to increase globally. Quirce is a co-author on the SABINA study, the largest real-world study on SABA use. It included 1 million people with asthma across five European countries. Among the findings were that overuse varied greatly by country. Overuse was 9% in Italy; 16% in Germany; 29% in Spain; 30% in Sweden; and 38% in the United Kingdom. In the UK, SABA overuse was greater for people with moderate-to-severe asthma compared with those who had mild asthma (58% vs 27%, respectively.) Quirce also pointed to a 2012 study in the Annals of Allergy, Asthma & Immunology of more than 33,000 patients that identified values of SABA that predicted exacerbations in children in adults. For adults, "use of 2 or more SABA canisters was found as the critical value with shorter optimal assessment periods of 3 and 6 months," the 2012 study found. "Each additional SABA canister resulted in an 8% to 14%" increase in the risk for asthma-related exacerbation in children and "a 14% to 18%" increase in that risk in adults. Patients become overreliant on the SABA inhalers, which have been in use for more than 50 years, for many reasons, Quirce said, despite the increased risk of exacerbations.

How Intranasal COVID Vaccines Could Be 'Holy Grail' of Vaccination

Jul 30 2021

Beyond the obvious advantage for the needle-phobic, the seven intranasal COVID-19 vaccines in development could offer two additional layers of protection against SARS-CoV-2 infection, experts say. First, intranasal vaccines could produce antibodies and attract other components of the immune system to the nose and upper respiratory tract, forming a first line of defense against infection. Second, if infection does occur, a local response in the nose can be faster than a systemic one, giving SARS-CoV-2 less of a chance to replicate, shed, and be transmitted to others. At least that's the idea. "We'll see how they fare in clinical trials, but research suggests that these types of vaccines should trigger a specialized immune response in the nasal passages that can help stop SARS-CoV-2 at the site of infection and reduce transmission," Troy D. Randall, PhD, said. Randall and co-author Frances Lund, PhD, analyzed the promise of intranasal COVID-19 vaccines in a perspective article published online July 22 in Science. Applying the vaccine directly to the inside or mucosa of the nose could be an advantage, agreed Deborah H. Fuller, PhD. "Mucosal immunity, especially for respiratory diseases, is a relatively untapped gold mine for vaccines," she said when asked to comment. Recent research from Fuller and colleagues, as well as others, suggests that immune responses on the mucosa can limit viral replication better than immune responses localized in the blood. "And this makes sense. If you have immune cells localized at the initial site where the virus infects, it could shut down the virus before it gets a chance to replicate," added Fuller, professor of microbiology at the University of Washington School of Medicine and chief of the Division of Infectious Diseases and Translational Medicine at the Washington National Primate Research Center, Seattle, Washington.

COPD worsens COVID-19 by altering epithelial cell genes

Jul 30 2021

New findings shed light on why chronic obstructive pulmonary diseases increase patients’ risks for severe COVID-19. The diseases cause genetic changes in the epithelial cells that line the airways, making the cells more vulnerable to attack from the coronavirus, researchers reported in Nature Communications. Laboratory studies of these cells found changes in their molecular makeup that likely make it easier for the virus to enter the body, make copies of itself, and trigger out-of-control immune responses that fill the lungs with fluid and cause severe organ damage. The researchers, led by Nicholas Banovich at Translational Genomics Research Institute in Phoenix, were only able to examine cells from lung-disease patients without COVID-19 but said their “study highlights crucial areas for future research.”

An active lifestyle may reduce the risk of sleep apnea

Jul 30 2021

Getting off the couch and into activities that get your body moving is linked to a decreased risk of obstructive sleep apnea (OSA), according to a wide-scale study that highlights the hazards of leading a sedentary life. The study, published in the European Respiratory Journal, tracked around 130,000 men and women in the U.S. over a period of 10 to 18 years and found that more movement and less sedentary behaviour were associated with a lower likelihood of OSA. “In our study, higher levels of physical activity and fewer hours of TV watching and sitting either at work or away from home were associated with lower OSA incidence after accounting for potential confounders,” said Tianyi Huang, an associate epidemiologist at Brigham and Women’s Hospital, a teaching hospital affiliated with Harvard University. “Our results suggest that promoting an active lifestyle may have substantial benefits for both prevention and treatment of OSA.” A 2014 study estimated that around 5.4 million Canadians have either been diagnosed with sleep apnea or are at high risk of the disorder. OSA, the most common type of sleep apnea, occurs when the upper airways become blocked, often because the soft tissue at the back of the throat collapses and obstructs the flow of oxygen to the lungs. This passage can also become comprised in people with large tongues, relaxed throat muscles or narrow airways. Family members are usually aware of the issue before those with the actual disorder, largely because obstructed airways can result in loud snoring followed by choking or gasping for breath during sleep. Many of the symptoms of OSA are felt the next day, including a morning headache, fatigue, irritability or mood changes, poor concentration, memory loss or a lowered sex drive. Serious cases of OSA can increase the risk of heart issues, including heart failure. Researchers used statistical modelling to compare physical activity and sedentary hours to OSA diagnoses. Moderate and vigorous physical activity were looked at separately and both were found to be strongly tied a lower risk of OSA, with no real difference detected between the intensity of the activity. The correlation was strongest for women, adults over the age of 65 and those with a BMI greater or equal to 25 kg/m2.

Virtual Space Created for Clinicians

Jul 19 2021

Dale Medical Products, Inc. has created a virtual space to allow clinicians, patients and purchasing/value analysis professionals the opportunity to learn about Dale products in a simulated setting. When visiting the Virtual Dale Medical Center, users can enter rooms by specialty to see products that are available for clinicians and their patients. Users can move around the room to view product videos and other information relevant to each care setting, select product(s) on the patient which enables contextual information, view 3-D product renderings and video presentations. There are other options to bring viewers to the Dale website, links to request samples, contact Customer Service or find local Sales Representatives. “Dale is proud to be among the leaders in the medical device manufacturing industry to deploy this technology. The Virtual Dale Medical Center will enable users to view and handle our products in simulated care settings,” states John Brezack, President of Dale. “The Virtual Dale Medical Center will empower our customers to see how our products can help care for patients and contribute to improved clinical outcomes. They can also view 3-D models of the products and request additional training and information.” The Virtual Dale Medical Center will continue to expand capabilities in the future, including a training center, “C-Suite” and other features.

Dräger Celebrates Legacy of Robert Kacmarek Through Ventilator Donation

Jul 14 2021

To help advance education in the respiratory therapy (RT) profession and honor the life’s work of Robert Kacmarek, PhD, RRT, FCCM, FCCP, FAARC, Dräger is donating a Babylog VN500 ventilator to each RT school throughout the Commonwealth of Massachusetts. This marks the seventh year of Dräger’s RT school donation program, which began in 2014. Dr Robert Kacmarek, professor of Anesthesiology at Harvard Medical School and the director of Respiratory Care at Massachusetts General Hospital, dedicated his career to the growth of the respiratory profession, serving as a member of the American Association for Respiratory Care (AARC) for more than 50 years, writing 19 textbooks, authoring or co-authoring over 300 articles, and presenting more than 700 lectures at respiratory care and medical conferences nationally and worldwide. He passed away on April 1, 2021. Jason Moury, MPH, RRT, president of the Massachusetts Society for Respiratory Care (MSRC), comments on Dr Kacmarek’s work and Dräger’s donation in his honor: “Bob was a humble giant who advocated for the profession and was world-renowned for his teaching. Words cannot express the loss that this profession will feel with his passing. We cannot thank Dräger enough for its donation. We appreciate all that the company has done in support of the RT profession and schools, including this latest contribution to Massachusetts RT programs.”“Robert Kacmarek was a driving force in furthering the RT profession, championing the advancement of higher education in the field, conducting decades of research on respiratory care interventions and training hundreds of students,” said Dräger Senior Vice President of Sales, Hospital Solutions, Steve Menet. “Through our donation of Babylog VN500 ventilators, we honor his legacy and support education of the next generation of respiratory care professionals by enabling them to train on advanced ventilation technology.”

Company Launches Telehealth Solution

JUL 7 2021

CAIRE Inc., pioneers of the portable oxygen concentrator and the only global manufacturer covering the entire continuum of care for the oxygen patient, announced the US launch of its next-generation telehealth solution – myCAIRE – at its corporate headquarters and Respiratory Center of Excellence. Designed to increase the efficiency of administering delivery and improve patient care, the application connects to CAIRE’s leading concentrators via the patient’s smart device and simplifies remote data collection through a secure, cloud-based technology in real-time — easily accessible via the medical equipment provider’s desktop. “It was important to us to have a telehealth solution that connected to CAIRE’s premier oxygen concentrators in the portable, transportable and stationary categories – the full spectrum of oxygen care for patients. Because of this, CAIRE is the only oxygen manufacturer that offers its provider partners a holistic approach to serving the complex healthcare needs of oxygen users during activity or when they are at home,” said Earl Lawson, President and CEO. The myCAIRE application is available through Android, iOS and Surface platforms, and the portal provides customizable views, filtering and search options to view oxygen usage, flow rates, device notifications, equipment location, and requests sent directly from patients to the provider through the app. The timing of the launch supports the needs of providers who administer care to oxygen patients with respiratory conditions, like Chronic Obstructive Pulmonary Disease (COPD), but also the growth in the population of users who have been prescribed oxygen as a therapeutic component to their recovery from the novel coronavirus, COVID-19. The development of telehealth solutions received a giant push during the pandemic according to global consulting firm McKinsey &amp; Company who estimates the market size up to $250 billion. They predict the shift to these platforms will continue to evolve with step-change improvements that impact a variety of providers ultimately resulting in better patient care and outcomes. “We see the use of telehealth as it applies to oxygen therapy equipment to only expand as adoption increases and access opens up,” said Barry Hassett, Vice President of Global Marketing. “This remote visibility to patient data allows the provider to engage with those patients who require more frequent touchpoints in their case management through personal contact and educational resources – the end result is improved care for patients.” In developing this next-generation telehealth solution, the CAIRE team prioritized improvements in functionality and usability while listening to the voice of customers – medical equipment providers who needed something that would help them remotely review data and troubleshoot devices efficiently during a time of increased oxygen demand in the treatment of COVID-19. “Streamlining oxygen patient management can assist in easing up on an already stretched bandwidth for our providers and their teams,” Hassett added. myCAIRE can connect wirelessly to the FreeStyle Comfort portable oxygen concentrator, the Eclipse 5 transportable oxygen concentrator, and the Companion 5 stationary oxygen concentrator. Most newly-prescribed oxygen users utilize a portable or transportable oxygen device to maintain their targeted saturation rate during their daily activities, and an at-home oxygen source – a stationary oxygen concentrator for when they are inside the home – particularly for use while they are at rest. myCAIRE setup is quick, and users will find the free application easy to use with features allowing them to view settings and notifications, share access with a caregiver, request service from their provider, and access the device user manual.

Company Signs Agreement with University

JUL 6 2021

Neotech Products has entered into a mutually beneficial agreement with Wichita State University. This exciting collaboration will provide Neotech with the resources of an institution well known for advanced research, including clinical work through their partners. Wichita State, a national leader in aerospace research, will benefit from the experience of a well-established and innovative medical device company as it expands research in the area of medical products. They will work closely with Neotech’s new product development team to explore product ideas that will impact the end user. “Wichita State is committed to using our aviation expertise for expanding research in other industries,” said Rick Muma, President of Wichita State University. “As a clinician in internal medicine and infectious diseases and a public health practitioner, I understand the need to continually innovate through collaboration in the healthcare sector. Partnerships with companies like Neotech Products do just that.” With this partnership, Neotech will have access to advanced facilities and technologies, including: Labs for materials and adhesive testing and research; Electron microscopes; CT scanning (for materials); Pull and compression testing; A wide array of 3D printing and scanning; VR visual design space. The partnerships’ first collaboration is a locking mechanism for the NeoBar ET Tube Holder. The idea originated with Dr Mohammed Ansari, a neonatologist with ties to the Wichita area. Wichita State teamed up with Dr Ansari and brought the idea to Neotech to drive the project forward. We’re extremely excited to see where it leads. Overall, the purpose of the partnership between Neotech and Wichita State is to utilize the combined expertise of both institutions to bring medical products to market that will truly make a difference.

Low-Dose Nitrous Oxide Shows Benefit for Resistant Depression

JUN 30 2021

A 1-hour treatment with a low concentration of nitrous oxide, commonly known as "laughing gas," appears to relieve symptoms of treatment-resistant major depression (TRMD), with effects lasting as long as several weeks, new research suggests. In a trial with a crossover design, investigators randomly assigned 28 patients with severe TRMD to receive a single 1-hour inhalation of placebo or nitrous oxide once a month over a 3-month period. Participants received an inhalation of placebo; a 25% concentration of nitrous oxide; and a 50% concentration of nitrous oxide. Sessions were conducted 4 weeks apart. Both doses of nitrous oxide were associated with substantial improvement in depressive symptoms for roughly 85% of participants. However, the 25% concentration had a lower risk for adverse effects, which included sedation, nausea, and mild dissociation, compared to the 50% concentration. "Twenty-five percent nitrous has similar efficacy, compared to 50% nitrous oxide, and reduced side effects fourfold," lead author Peter Nagele, MD, chair and professor of anesthesia and critical care, University of Chicago, Chicago, Illinois, said. "We also observed that many patients had a 2-week improvement of depressive symptoms after a nitrous oxide treatment," said Nagele, who is also a professor of psychiatry and behavioral neuroscience.

Frequent Snoring Tied to Increased Asthma Symptoms, Healthcare Use in Kids

JUN 30 2021

Habitual snoring increases odds for maximum asthma symptom days and health care utilization in children with persistent asthma, a study of inner-city kids suggests. Researchers examined data on 339 children (mean age 7.9 years) with persistent asthma whose parents or caregivers completed quarterly surveys for 12 months on asthma symptoms, snoring, health care use, and other outcomes such as missed school for children and disrupted plans or sleep for caregivers. Habitual snoring, defined as at least six nights a week, was reported for 24.8% of the children at the initial assessment. Habitual snorers had significantly more “maximum symptom days” than non-snorers (3.8 vs 2.7 days, odds ratio 1.58), which researchers defined the number of days in the previous two-week period that the children had wheezing, chest tightness, or cough or experienced disrupted sleep or play due to these symptoms. These results aren’t surprising because many risk factors that can increase snoring – pollutants, poor air quality, and tobacco smoke exposure – disproportionately impact inner-city children and can also exacerbate asthma symptoms, said senior study author Dr Wanda Phipatanakul, a researcher at Harvard Medical School and Boston Children’s Hospital. “Awareness of early detection of these factors can help inform early intervention to reduce the morbidity and long-term complications from asthma,” Dr Phipatanakul said by email. A majority of children in the study were from low-income households (72.2%), defined as less than $45,000 a year, and a majority of kids were Black (31.5%) or Hispanic (36.3%). Overall, about half the children in the study had overweight (14%) or obesity (35%), and these conditions were even more prevalent among habitual snorers (17% and 45%, respectively). Habitual snorers were more likely to be obese than non-snorers. The study also found that habitual snoring, compared to non-snoring, was associated with health care utilization (incidence rate ratio 1.72) and worse asthma control (OR 1.49). One limitation of the study is that researchers lacked objective measurements of sleep disordered breathing, the authors note in the Journal of Allergy and Clinical Immunology: In Practice. Recall bias in caregiver reports of asthma symptoms or snoring frequency also may have influenced the results.

Dose-Dependent Effect of 'Internet Addiction' and Sleep Problems

JUN 30 2021

More evidence suggests the severity of internet addiction (IA) is directly related to the severity of sleep problems in youth. Results from a study of more than 4000 adolescent students show IA severity was linked to less sleep and to daytime sleepiness. In addition, boys aged 12-14 years who were addicted to computer games vs social media networking were the most affected. Sleep issues could be "easily detectable manifestations of pathological internet addiction," investigator Sergey Tereshchenko, PhD, Scientific Research Institute for Medical Problems of the North, Krasnoyask State Medical University, Krasnoyarsk, Russia, said. These sleep problems require attention and correction, Tereshchenko added. The findings were presented at the virtual Congress of the European Academy of Neurology 2021. IA is a relatively new psychological phenomenon and is most prevalent in "socially vulnerable groups," such as adolescents, Tereshchenko said. He cited numerous studies that have "convincingly demonstrated" IA is comorbid with a broad range of psychopathologic conditions, including depression, anxiety, and attention deficit hyperactivity disorder. There is also growing evidence, including from systematic reviews in 2014 and 2019, that IA affects a wide range of sleep parameters. However, most studies in adolescents have used only one psychometric tool to assess addiction, revealing only the "general IA pattern" and not the type of IA, Tereshchenko noted. Adolescents may not be addicted to the internet itself but to certain behaviors like gaming or social networking, he said.

Poor Sleep History Linked With More Severe COVID-19

JUN 30 2021

Poor sleep habits may be linked with higher risk for severe illness in patients with COVID-19, according to Harvard University researchers. They analyzed survey responses from more than 46,000 participants in the long-term UK Biobank study, including 8,422 who tested positive for COVID-19. Participants had answered questions from 2006 to 2010 about sleep duration, daytime sleepiness, insomnia and body clocks. For the new study, based on their responses, the researchers assigned scores ranging from 0 to 6, with higher scores indicating multiple poor sleep “traits.” In participants with COVID-19, poor scores were associated with higher odds of death. This was true even after researchers accounted for issues known to be risk factors for poor COVID-19 outcomes such as sleep apnea, obesity and smoking, they reported on Friday in the journal Clinical Infectious Diseases. Even people with two occasional or one frequent poor sleep trait appeared to experience higher risks for hospitalization and death, although the difference was not statistically significant and more study is needed to confirm the finding, the researchers said. Poor sleep affects the immune system and blood clotting, both of which are key to the body’s fight against COVID-19, and “tracking sleep behavior may have importance in identifying those at increased risk for COVID-19 mortality and hospitalization,” the authors said.

Diagnostic Product Range Updated to Spirometry Standards

JUN 29 2021

NDD Medical Technologies (NDD), a leading provider of diagnostic technology enabling healthcare professionals the early detection of COPD and other chronic lung diseases, has updated the entire EasyOne product range, including the EasyOne Air, Easy on-PC, EasyOne Pro, and EasyOne Pro LAB, to be compliant with the ATS/ERS Standardization of Spirometry 2019. Spirometry is widely used in the assessment of lung function to provide objective information used in the diagnosis of lung disease and monitoring lung health. The updated guidelines aim to improve the quality of the spirometric measurements and improve the patient experience. Committed to usability since the very first EasyOne spirometer, NDD continues this tradition during the implementation of the spirometry 2019 update. The user interface across the product line has seen a major update to help the user navigate through the changes. This is particularly noticeable in the quality assessment of the measured FEV1 and FVC parameters, and the overall quality grading of a test session. As obtaining a high-quality result is essential to the accurate interpretation of the spirometry test outcome, each quality-related criterion proposed by the ATS/ERS standard is analyzed. The user is presented with clear messages on which quality criteria have not been fulfilled, and most importantly, how to coach the patient in order to meet the criteria. The implementation of the ATS/ERS Standardization of Spirometry 2019 update across the entire EasyOne product line is indeed a milestone moment in NDD’s mission of offering reliable, innovative, and easy-to-use products for physicians and patients to combat respiratory disease. However, the journey does not end here, as NDD continues to improve and expand the capabilities of its products and services. The software update with the ATS/ERS spirometry standard 2019 content can be downloaded free-of-charge for EasyOne Air, Easy on-PC, EasyOne Pro and EasyOne Pro LAB at

Committed to Education, MGC Diagnostics Launches Book Giveaway

JUN 23 2021

MGC Diagnostics is the leader in cardiopulmonary diagnostic systems and providing educational opportunities to the respiratory community. Through the years, MGC Diagnostics has been deeply committed to supporting and providing speakers for diagnostic seminars and webinars in addition to state, national & international conferences, as well as other forums throughout the world. They truly believe that knowledge is power, and that the more information you have, the better you can serve your patients and staff. As a way to show their appreciation to those who perform diagnostics testing, MGC Diagnostics is giving away 20 copies of “Ruppel’s Manual of Pulmonary Function Testing”. But the best part is that each book has been individually autographed by both Gregg and Carl – a sure collector’s item. Deadline to enter is July 31st. Winner will be notified by email. Sign up here:

OxyGo Acquires Maker of Portable Emergency Oxygen Devices

MAY 13 2021

OxyGo LLC, a leader in lightweight portable oxygen concentrators, has acquired LIFE Corporation, a manufacturer of medical devices that specializes in portable Emergency Oxygen and CPR administration equipment. Founded in 1985, LIFE Corporation specializes in AED companions to provide supplemental oxygen to a breathing victim before the onset of fibrillation, oxygen enriched CPR to a non-breathing victim, or continued supplemental oxygen after successful defibrillation. LIFE also provides a complete line of medical oxygen regulators and cylinders for LIFE products and separately for EMTs, hospitals, and the home care market. “Acquiring LIFE Corporation is an exciting and logical next step in offering proactive gas solutions to the medical and industrial markets,” said V.E. Marquard-Schultz, Esq., “and continues our mission to help our customers and communities grow.” The acquisition of LIFE Corporation fits into OxyGo’s strategy to offer high quality and market leading service to compressed gas users and the home healthcare market. By purchasing LIFE Corporation, OxyGo can expand their oxygen expertise even further, providing the best product and service. OxyGo is noted for providing high quality home healthcare oxygen products and has been rated as the industry’s best POC—ahead of all competitors the last four years in a row and established itself as a leader of portable oxygen concentrators in North America.

Study Investigates the Ability of Masimo PVi to Predict Preload Responsiveness in Patients On Nasal High-Flow Therapy

MAY 3 2021

Masimo announced the findings of a study published in the Journal of Applied Physiology in which Dr Marina García-de-Acilu and colleagues at the Vall d’Hebron University Hospital in Barcelona evaluated the utility of Masimo PVi as a noninvasive method of predicting preload responsiveness in patients treated with nasal high-flow (NHF) therapy. They found that PVi may identify preload responders and noted that PVi may therefore be used in the “day-to-day clinical decision-making process in critically ill patients treated with NHF, helping to provide adequate resuscitation volume.” More than 100 independent studies have demonstrated the utility of PVi as an indicator of fluid responsiveness. This is the first time PVi has been evaluated in patients treated with NHF therapy. Noting the potential convenience of a noninvasive method of predicting fluid responsiveness in NHF patients, the researchers sought to evaluate whether PVi, which is noninvasive and easy to use, could play such a role. To do so, they compared PVi to reference measurements—stroke volume (SV) and cardiac output (CO)—in 20 adult ICU patients with acute respiratory failure (ARF) supported by NHF (flow ≥ 30 L/min). SV and CO were measured using transthoracic echocardiography (TTE) using a portable echocardiogram. PVi was measured using a Masimo Radical-7 Pulse CO-Oximeter with a pulse oximetry sensor attached to the finger. Within the first 24 hours of NHF support, the patients’ SV/CO and PVi were assessed. Passive leg raising (PLR) was performed and SV/CO and PVi were then reassessed. Preload responsiveness was defined as a ≥ 10% increase in SV after PLR. A fluid challenge was then conducted by administering a 250-mL saline solution to patients who were found to be preload responders (12 of the 20 patients). SV/CO and PVi were measured again after the fluid challenge in these patients. The researchers found that preload responders showed higher baseline PVi values and ΔPVi after PLR. PVi and ΔPVi after PLR showed “excellent diagnostic accuracy for predicting preload responsiveness.” At a baseline cut-off value of 16%, PVi had sensitivity of 91.7% and specificity of 87.8% for discriminating between preload responders and non-responders; a change of 2% or more in PVi allowed for discrimination between the two groups with 100% sensitivity and specificity. Additionally, the researchers found that ΔPVi after PLR and after fluid challenge were strongly correlated (r = 0.84, p < 0.001). The researchers concluded, “This physiological study suggests that PVi might predict preload responsiveness in hypoxemic ARF patients treated with NHF. Further research should focus on validating these results and analyze whether PVi-guided fluid administration can improve outcomes in NHF patients.” The researchers also noted that PVi may not be sufficient to identify preload responders in all patients using NHF, hypothesizing that the intrathoracic pressures delivered by NHF are lower than those generated during invasive mechanical ventilation and that therefore a certain degree of hypoperfusion might potentially be required to effect changes in baseline PVi. The accuracy of PVi in predicting fluid responsiveness is variable and influenced by numerous patient, procedure, and device-related factors. PVi measures the variation in the plethysmography amplitude but does not provide measurements of stroke volume or cardiac output. Fluid management decisions should be based on a complete assessment of the patient’s condition and should not be based solely on PVi. In the US, PVi is cleared as a noninvasive, dynamic indicator of fluid responsiveness in select populations of mechanically ventilated adult patients.

Company Unveils New Website

APR 27 2021

Vitalograph (USA) Inc. is inviting visitors to explore their new website – The new website allows customers to see the full range of Vitalograph products and services, through a more user-friendly experience with improved navigation and functionality. Created with the customer in mind, the site includes many new features and information on respiratory diagnostic devices, medical equipment, clinical trial services and medical research papers for the respiratory community. New features include: Website split into Healthcare and Clinical Trials to suit the customer journey. Rapid response functionality allowing compatibility with various browsers and mobile devices. Reference Paper Resource area. Clinical Practise Guidelines area. Reimbursement codes information. Product filters to easily narrow down the product portfolio. Online shopping with new cart functionality to streamline the purchasing process. Full information on Vitalograph’s Clinical Trial product solutions and services. Look ahead navigation which reduces the number of clicks to navigate the site. 5 Year-Product Registration and Spirotutor Online Training. In addition, the new product filters allow Vitalograph to place their complete portfolio on the site while still allowing the user to easily navigate through the line. The new Resources section allows visitors to stay informed with the latest industry news, guidelines, and references. The user is always just one click away from useful and pertinent respiratory research, clinical practice guidelines and other spirometry information. Vitalograph is a world-leading provider of the highest quality respiratory diagnostic devices, clinical trial services and medical equipment servicing. With a pioneering heritage of excellence spanning over half a century, Vitalograph continues to make valuable contributions to effective medical care and enhanced quality of life.

Company Launches New Software into the US

APR 27 2021

Vitalograph is excited to launch the next generation Spirotrac 6 software into US Healthcare and Occupational Health. Spirotrac 6 PC software provides a powerful respiratory diagnostic platform. This redesigned software is compliant with 2019 ATS/ERS spirometry guidelines, meeting international guidelines on accuracy and reporting. The software includes a 12-lead electrocardiogram (ECG) option with detailed results based on the University of Glasgow interpretation algorithm. A brand-new user interface provides advanced quality control feedback for rapid and easy testing. Filing and storing results could not be simpler with fast connection to your electronic medical record (EMR) system, streamlining your clinical workflow. Five Key Benefits: supports full-feature spirometry testing and bronchodilator responsiveness testing with over 50 available parameters; rovides instant quality feedback using the latest 2019 ATS/ERS spirometry grading, test/session acceptability, usability, and repeatability criteria; uses latest global lung function initiative (GLI) predicted equations with lower limit of normal (LLN), Pred and Z-scores for accurate assessment of abnormality; saves time and ensures consistency with Standardised Operator Comments to quickly add comments to the subject record; ombines spirometry and ECG into one comprehensive patient record. The integrated Glasgow Algorithm provides a computer-generated analysis of potential cardiac abnormalities, a full range of parameters, interpretation, and rhythm analysis.

Company Launches New Device

APR 27 2021

Vitalograph are excited to launch the next generation Pneumotrac spirometer into the US market. The next-generation Vitalograph Pneumotrac Spirometer, combined with Spirotrac PC software, is a powerful tool for respiratory diagnosis of both adults and pediatrics. Capture reliable test results immediately with Pneumotrac’s precise and durable measuring technology which is extremely accurate and stable over time. Connects instantly to your PC by USB, delivering results through the new, improved Spirotrac 6 software. Compliance with the 2019 ATS/ERS spirometry update ensures your service meets international guidelines on accuracy and reporting. The Vitalograph Pneumotrac Spirometer easily connects to your Electronic Medical Records (EMR) system to streamline your clinical workflow. Features include: Highly accurate, robust, and stable Fleisch flow measuring technology with no moving parts; supports full-feature spirometry testing and bronchodilator responsiveness testing with over 50 available parameters; instant quality feedback using the latest 2019 ATS/ERS grading, test/session acceptability, usability, and repeatability criteria; low running costs and environmentally friendly: no need for costly disposable sensors, turbines, adaptors, or flow tubes. Plus free online training and a five-year warranty.

Masimo Announces FDA Clearance of Radius PCG

APR 12 2021

Masimo announced that Radius PCG, a portable real-time capnograph with wireless Bluetooth connectivity, has received FDA 510(k) clearance. Radius PCG connects with the Root Patient Monitoring and Connectivity Platform to provide seamless, tetherless mainstream capnography for patients of all ages. Radius PCG joins the growing family of tetherless Masimo technologies that includes Radius PPG, which offers Masimo SET Measure-through Motion and Low Perfusion pulse oximetry, and Radius T, which provides continuous temperature measurements. Radius PCG requires no routine calibration, with accurate end-tidal carbon dioxide (EtCO2) and respiration rate measurements and continuous EtCO2 waveforms displayed within 15 seconds—all in a small, portable package that can fit in the palm of a hand. “Radius PCG has been a game changer for our clinical team,” commented Joseph DiMartino, MSN RN, NE-BC, CCRN-K, Associate Vice President of Nursing at Temple University Hospital in Philadelphia. “It provides us with a portable and rapid measure of capnography for confirming airway placement in accordance with AHA guidelines.” Wirelessly connected to Root, Radius PCG presents a compelling mainstream capnography solution, offering: Cable-free Capnography: High-quality capnography without a tethered connection to Root reduces the possibility of an interruption in capnography monitoring by minimizing tugging on the breathing circuit. In busy operating rooms, where space is already at a premium, and where capnography cables can easily be pulled and dropped on the floor—potentially damaging the fragile and expensive capnography sensor head—the reduction in clutter may be especially welcome. Automated Documentation: Root, in conjunction with the Masimo Hospital Automation Platform, automates electronic charting of patient data, including the data collected by Radius PCG, in hospital electronic medical record (EMR) systems, to simplify and speed workflows, as well as reduce the likelihood of transcription errors. Maximized Data Visibility and Manipulation: Root’s large, multi-touch, high-resolution screen provides an easily interpretable secondary display of large, crisp EtCO2 waveforms, improving visibility and assisting clinicians in identifying wave patterns suggestive of airway obstruction or tube dislodgement. Clearly displayed trend data for up to 96 hours helps clinicians review patient progress over time, helping guide ventilation efforts. And the intuitive touch-screen interface allows clinicians to quickly adjust the trend display range and configure alarm settings to meet the needs of each patient. Hassle-free Connectivity: Radius PCG quickly and effortlessly pairs with Root via Bluetooth, supporting seamless integration into clinical workflows while providing the benefits of reliable capnography. Tom Friedland, MD, Emergency Medicine Physician, described Radius PCG as “the easiest and most affordable solution to switch your hospital from the unreliable color change CO2 detector to waveform capnography. #NoTraceWrongPlace.” “Radius PCG is indispensable for emergencies, as well as for monitoring the COVID patients in our house,” added Kai Schurig, Head of the Biomedical Department at Marien Hospital in Hamburg, Germany. “These handheld devices are very reliable and fail very rarely. The users are very satisfied and treat the device accordingly.” Root is a powerful, expandable hub that integrates an array of technologies, devices, and systems to provide multimodal monitoring and connectivity solutions. Root’s plug-and-play expansion capabilities allow clinicians to simultaneously monitor with Radius PCG and many other measurements, such as Masimo SET, advanced rainbow Pulse CO-Oximetry measurements, O3 regional oximetry, and SedLine brain function monitoring, for expanded visibility of patient status. Using Root in combination with the Hospital Automation Platform, monitoring data from all connected devices can be automatically charted in EMRs. Joe Kiani, Founder and CEO of Masimo, said, “With its wireless connectivity, Radius PCG is a powerful and useful tool for assessing end-tidal CO2 in a multitude of clinical scenarios. Masimo continues to make clinically relevant, accurate patient data available, helping clinicians gain the insights they need to make the best decisions and improve patient outcomes.”

FDA Approves Xolair (omalizumab) Prefilled Syringe for Self-Injection Across All Indications

APR 12 2021

Genentech, a member of the Roche Group announced that the US Food and Drug Administration (FDA) has approved the company’s supplemental Biologics License Application for Xolair (omalizumab) prefilled syringe for self-injection across all approved U.S. indications. Xolair is the only FDA-approved biologic designed to target and block immunoglobulin E (IgE) for the treatment of moderate to severe persistent allergic asthma, chronic idiopathic urticaria (CIU) and nasal polyps. “Today's approval reflects our commitment to continued innovation with Xolair to address the critical needs of people living with allergic and inflammatory conditions,” said Levi Garraway, M.D., Ph.D., chief medical officer and head of Global Product Development. “Appropriate patients will now have the flexibility to administer Xolair from home, which is particularly important for those who are considered high-risk during the COVID-19 pandemic.” Before starting self-injection with Xolair prefilled syringe, the patient must have no prior history of anaphylaxis and be closely observed by a healthcare provider for at least three injections with no hypersensitivity (allergic reactions). After Xolair therapy has been initiated and safely established in a healthcare setting, a healthcare provider may determine whether self-injection with Xolair prefilled syringe by the patient or a caregiver is appropriate. The healthcare provider must train the patient or caregiver on the correct subcutaneous injection technique, how to recognize the signs and symptoms of anaphylaxis and how to treat anaphylaxis appropriately, before the first self-injection outside a healthcare setting. “Expanding treatment options for personalized care and self-management is always welcome news for the patient community,” said Kenneth Mendez, CEO and President, Asthma and Allergy Foundation of America. “The possibility of administering FDA-approved treatment outside of the healthcare provider’s office, but still guided by that healthcare provider, may reduce barriers to care for patients and their caregivers.” Approximately 460,000 patients have been treated in the US with Xolair since its initial approval in 2003. The use of Xolair across allergic asthma, CIU and nasal polyps is based on its well-established efficacy and safety profile and supported by a robust clinical development program, including 10 Phase III studies. In the US, Genentech and Novartis Pharmaceuticals Corporation work together to develop and co-promote Xolair.

Confront Today’s Challenges with Cardiorespiratory Diagnostic Software

MAR 29 2021

The respiratory industry is ever growing and changing. With new studies and trials being conducted, new treatment methods and disease challenges are often discovered. This means that reliable and efficient methods for diagnosing pulmonary disorders are needed. As COVID-19 continues, mild to severe lung damage has been found in some patients post-Covid, which often requires Pulmonary Function Tests to determine the extent of damage, monitor the progress and to create a treatment plan. Add to that the number of patients with Chronic Obstructive Pulmonary Disease (COPD), a progressive and chronic disease. According to the American Lung Association, COPD is the third leading cause of death in the world. It is estimated that over 300 million people worldwide have COPD. As we can see, the need for Pulmonary Function Testing is only going to increase. In the respiratory industry, manufacturers introduce new diagnostic software about once every 15 years. With these thoughts in mind, MGC Diagnostics has a solution to help solve today’s challenges. MGC Diagnostics’ new Ascent cardiorespiratory diagnostic software for pulmonary function testing has been designed from the ground up to be the most advanced testing software platform available. Their easy-to-use, powerful, and versatile software allows you to obtain the very best data possible so that a diagnosis can be made confidently. It’s simple. Improving the diagnosis of patients starts with diagnostic tests done correctly and according to ATS/ERS standards. The ease in which data is collected, accessed, and reviewed helps to ensure an effective patient outcome. The dynamic on-screen instructions within the software walk the technologist through the entire testing process. Ascent software’s unique Insight quality control gauge shows if an effort has passed ATS/ERS quality standards in Real-Time while the patient is performing the effort. With enhanced graphics, know at-a-glance if a test effort meets your labs’ standards and are acceptable for diagnostic purposes. After the test is complete, data can be reviewed quickly and efficiently. Completely customizable comments can be generated to summarize the quality of each effort more quickly and accurately than ever before. And the computerized interpretation can be tailored to the individual physician.

Study Investigates the Impact of Automating Respiration Rate Measurement Using this Device

MAR 29 2021

Masimo announced the results of a prospective, observational study published in Acta Paediatrica in which researchers from the Hospital for Sick Children in Toronto evaluated the accuracy of plethysmographic respiration rate measurement (RRp) using Masimo Rad-G, a rugged, handheld device, on malnourished, hospitalized children in Nigeria. Noting that in resource-limited environments, respiration rate (RR) measurement is often used to directly inform medical decisions for children with respiratory problems, but that manual RR counting “remains a challenge,” Dr Nancy Dale and colleagues investigated whether a technological solution might provide a useful alternative to manual counting. To make the evaluation, the researchers compared simultaneous device measurements and nurse-measured manual RR counts on malnourished children. The device chosen was the Masimo Rad-G, which uses a pulse oximetry sensor to measure both oxygen saturation and RRp, and which has been shown to provide good agreement between RRp and pediatrician-measured RR. They enrolled 514 children, aged 6 to 59 months, who were hospitalized between July 2019 and May 2020, in Borno State, Nigeria. Study nurses were trained to operate Rad-G and also perform manual RR counts as part of twice-daily patient assessment. RR was manually counted for 60 seconds while Rad-G simultaneously measured RRp via a sensor attached to the patient’s toe, and both measurements were recorded. Analyzing the 6,889 paired RR measurements, the researchers found that the mean Rad-G RRp reading was 1.3 bpm (95% confidence interval 1.2 – 1.4 bpm) higher than the mean manual RR value. The mean absolute difference between the two methods was 4.4 bpm (95% CI 4.3 – 4.5 bpm). When RR was classified as either “normal” or “fast” breathing (using WHO pneumonia thresholds), the two methods resulted in the same classification 84% of the time. When RR was classified according to BedsidePEWS RR sub-scoring (a 4-point scale), 80% of the scores were the same, and 99.3% were within 1 point. The researchers concluded that their findings “highlight the potential clinical impact of changing practice from manual to automated RR count. Clinical implementation of the device should be carefully monitored to measure impact on patient outcomes.” Study co-author Dr Stanley Zlotkin commented, “Technical solutions to improve clinical care are laudable. We look forward to continuing this research.” RRp is one of multiple RR monitoring modalities offered by Masimo, which also include acoustic respiration rate (RRa) and NomoLine capnography (RRc), helping clinicians ensure they have the most suitable tool for each patient scenario. First developed in partnership with The Bill & Melinda Gates Foundation, Rad-G is a rugged, handheld device that provides clinically proven Masimo SET pulse oximetry, respiration rate (RRp), and other important parameters. With its long-lasting rechargeable battery, robust rubber casing, and light weight, Rad-G makes it easier for clinicians to quickly assess patients and make informed care decisions anywhere pulse oximetry or vital signs checking is needed in a compact, portable form factor. Coupled with the universal Mini-Clip pulse oximeter sensor to provide the ultimate in handheld versatility, Rad-G can be used in a variety of settings, including limited-resource environments, both indoors and in the field.

FDA Clears Use of Oscillating Positive Expiratory Pressure Products

MAR 19 2021

D•R Burton Healthcare Products LLC is a leading manufacturer of Oscillating Positive Expiratory Pressure (OPEP) products that treat the symptoms of COVID-19. D•R Burton OPEP products provide supporting treatment of some COVID-19 symptoms, particularly symptoms of respiratory airway infections that can precede pneumonia and further progress to more serious complications. The FDA has cleared the use of Oscillating Positive Expiratory Pressure (OPEP) products which are known to decrease the burden of respiratory pathogens by promoting airway secretion clearance. OPEPs are widely accepted by the medical community for helping to reduce the likelihood that respiratory infections progress to pneumonia and even more serious complications including death. Despite the familiarity in the medical community with these products, OPEPs are largely unknown to the U.S. general public except for patients living with chronic lung diseases such as Cystic Fibrosis, COPD, and Bronchiectasis to name a few. D•R Burton manufactures small hand-held OPEPs that can be easily self-administered in hospitals, nursing homes, and the home setting by most patients. These devices can also be filtered with a common bacteria/viral filter to alleviate concern of droplet transmission. While researchers race for a cure, our country and the world face a public health challenge of treating infected people. OPEP therapy is not a direct treatment for the COVID-19 virus, but it is our hope that increased awareness of OPEP therapy could help in the current health challenge by offering proven and available therapy for symptoms of respiratory tract infections associated with the COVID-19 virus.

Survey Shows Stress Over the Past Year Is Negatively Impacting Quality of Sleep

MAR 15 2021

ResMed, a world-leading digital health company, announced today the results of a nationwide survey of 1,000 adults, which revealed that for half of Americans, stress over the past year is negatively impacting the quality of their sleep—and many are ignoring sleep challenges that could point to a larger underlying health concern. ResMed published the survey in conjunction with National Sleep Awareness Week (March 14-20) and World Sleep Day (March 19), and as part of Sleep for a Better Tomorrow, an education and outreach initiative to build awareness of the critical role good sleep plays in physical and mental health—and how to get our best sleep. “COVID-19 has impacted all aspects of our lives, including our sleep health, leading many people to struggle to get the recommended seven to nine hours of sleep at night,” said Carlos M. Nunez, M.D., chief medical officer for ResMed. Beyond the pervasive effects of stress, the survey found the impacts on sleep vary across gender and working arrangements: 35% of women reported worse sleep quality in the past year compared to just 26% of men. Women selected stress and anxiety as the most significant impacts on their sleep; more individuals working from home reported improved sleep quality since the pandemic began vs. those who haven’t worked from home (39% vs. 21%). Across all respondents, more than one-third say they are having a harder time falling asleep, and nearly one-third say they are sleeping less over the last year, and one-quarter started taking naps more often. While COVID-related stresses are often noticeable, one of the biggest stealers of our sleep might be something we can’t easily detect: sleep apnea. The survey revealed that more than one in two Americans say they snore, or a bed partner has told them they snore, yet 78% of those who snore aren’t concerned it could be related to an underlying health condition, despite snoring being a top symptom of sleep apnea. Additionally, nearly half of survey respondents said their doctor had not asked them about their sleep quality, reinforcing the importance of consumers being aware of the potential health impacts of poor sleep and acting on key sleep apnea symptoms such as snoring. “While data show that stress and worry are key factors impacting many people’s sleep, now is an opportunity for everyone to take measure of all of the factors that could be impacting the quality of their sleep, which could include sleep disorders that can have negative long-term impacts to overall health,” said Nunez. Everyone experiences a lousy night of sleep once in a while; however, those who experience ongoing sleep issues could be dealing with a more significant underlying health condition. Most survey respondents who snore overwhelmingly discount the potential health impacts, yet snoring is the most prevalent symptom of sleep apnea – one of the most common sleep disorders. Over 54 million adults in the U.S. have sleep apnea, but more than 80% don’t know they have it. Undiagnosed and untreated sleep apnea may increase your risk for developing other chronic and life-threatening conditions, including high blood pressure, heart disease, and Type 2 diabetes. “Sleep apnea can impact all types of people from all walks of life, and while some people are more prone to have sleep apnea, it does not discriminate,” said Nunez. “If you snore, have been told you stop breathing in your sleep, or feel tired each day despite getting enough hours of sleep, ask your doctor if sleep apnea – which is 100% treatable at home – could be the cause.” To learn more about ResMed’s sleep surveyor to take a free quiz about your risk for sleep apnea, visit

New Study Evaluates the Ability of Masimo EMMA Capnography to Assess the Respiratory Status of Children with Tracheostomy

MAR 15 2021

Masimo announced the findings of an observational, retrospective study published in Pediatrics International. In the study, researchers at the Osaka Women’s and Children’s Hospital in Japan found the Masimo EMMA Portable Capnograph “useful for assessment of the respiratory condition in children with tracheostomy.” EMMA provides seamless mainstream capnography for patients of all ages in a compact, easily portable device. The device requires no routine calibration and minimal warm-up time, with accurate end-tidal carbon dioxide (EtCO2) and respiration rate measurements and continuous EtCO2 waveforms displayed within 15 seconds. Noting the potential value of a compact and portable way to monitor changes in respiratory status for patients in scenarios where typical inpatient hospital monitoring equipment is less likely to be available, Dr Masashi Hotta and colleagues sought to evaluate the utility of the EMMA capnograph on children with tracheostomy by comparing EtCO2 values from the EMMA device (which was connected to the distal side of the tracheostomy cannula) to invasively measured partial pressure of venous carbon dioxide (PvCO2). Although partial pressure of arterial carbon dioxide (PaCO2) is considered a gold standard for assessing respiratory condition, the researchers chose PvCO2 because “collection of arterial samples is more invasive than collection of venous samples” and noted that studies have shown a correlation between PaCO2 and PvCO2. They enrolled 9 infants (median age 8 months) and compared 43 paired EtCO2-PvCO2 readings in total. The researchers found a correlation coefficient of 0.87 (95% confidence interval of 0.7 – 0.93; p < 0.001) between EtCO2 and PvCO2 readings. Analysis of the data revealed that EtCO2 readings were, on average, 10.0 mmHg lower than the corresponding paired PvCO2 value (95% limits of agreement of 1.0 – 19.1 mmHg). The researchers speculated that the tendency for EtCO2 to be lower than PvCO2 may be explained by “gas mixing proximal to the tracheostomy cannula due to the presence of anatomic and physiologic dead space. Because almost all patients used a cannula without a cuff, some air leakage may have occurred. In addition, about two-thirds of the patients had [chronic lung disease or bronchopulmonary dysplasia],” which they noted have been shown to cause lower CO2 concentrations during exhalation, relative to the partial pressure of CO2 in the blood. They also found that the median difference in values was significantly greater for readings collected while patients were on mechanical ventilation (28 of the 43 data pairs). With a ventilator, there was a median 11.2 mmHg (6.8 – 14.3) difference; without a ventilator, there was a median 6.6 mmHg (4.1 – 9.0) difference (p = 0.043). The researchers noted that use of a ventilator was significantly related to the difference in paired readings because patients on ventilators had respiratory or circulatory disease. Noting that, “We demonstrated a strong positive relationship between PvCO2 and EtCO2 and revealed the availability and usefulness of this capnometer for children with tracheostomy,” the researchers concluded, “EMMA is useful for assessment of the respiratory condition in children with tracheostomy. EMMA can be used especially in home-care settings and outpatient departments for such children.” They also noted, “The main strength of this study is that we used a portable capnometer to evaluate EtCO2.”

Asthma-COPD Overlap Linked to Occupational Pollutants

MAR 15 2021

The development and worsening of overlapping asthma and chronic obstructive pulmonary disease (COPD) can be affected by pollutants found in rural and urban environments, according to a recent presentation at the annual meeting of the American Academy of Allergy, Asthma, and Immunology, held virtually this year. a“Urban-rural-occupational air pollutants or respiratory sensitizers impact asthma and the asthma-COPD overlap features,” Jill A. Poole, MD, division chief of allergy and immunology at the University of Nebraska Medical Center, Omaha, said in her presentation. The Global Initiative for Asthma (GINA) first outlined a syndrome in 2015 described as “persistent airflow limitation with several features usually associated with asthma and several features usually associated with COPD” and called asthma-COPD overlap syndrome. In 2017, a joint American Thoracic Society/National Heart, Lung, and Blood Institute workshop outlined knowledge gaps about asthma-COPD overlap, noting it “does not represent a single discrete disease entity.” “This is not a single disease and should be thought of as being heterogeneous and used as a descriptive label for patients commonly seen in clinical practice,” Dr Poole said. “Both asthma and COPD definitions are not mutually exclusive because each disease includes several phenotypes with different underlining mechanisms.” An example of how asthma-COPD overlap might present is through a patient with allergic asthma who has a history of smoking who develops airflow obstruction that isn’t fully reversible, or a patient with COPD “with high reversible airflow, obstruction, type 2 inflammation, and perhaps the presence of peripheral blood eosinophils or sputum eosinophils.” A patient’s interaction with urban, rural, and occupational environments may additionally impact their disease, Dr Poole explained. “The environmental factors of an urban versus rural environment may not be necessarily mutually exclusive,” she said. “It’s also important to recognize occupational exposures that can be both seen in an urban or rural environment [can] contribute to asthma-COPD overlap.” In a study of 6,040 men and women with asthma living in Canada, 630 (10.4%) had asthma-COPD overlap, with increased air pollution raising the likelihood of developing asthma-COPD overlap (odds ratio, 2.78; 95% confidence interval, 1.62-4.78). These people experienced later onset asthma, increased emergency department visits before a diagnosis of COPD, and increased mortality. Another study in Canada of women from Ontario in the Breast Cancer Screening Study found 1,705 of 4,051 women with asthma also had COPD. While air pollution did not increase the risk of developing asthma-COPD overlap, there was an association between body mass index, low level of education, living in a rural area, and smoking status. Among farmers in rural areas, “it has been recognized that there is something called the asthma-like syndrome that’s been reported in adult farming communities,” Dr Poole said, which includes “some degree of airflow obstruction and reversibility” that can be worsened by smoking and could be an overlap of asthma and COPD. Farmers can also experience asthma exacerbations while working, and “livestock farmers appear more at risk of developing [chronic bronchitis and/or COPD] than do the crop farmers,” she noted. Occupational environments outside of agriculture exposure can cause incident asthma, with high-molecular-weight antigens such as flour cereal, animal dander, latex, psyllium, crab processing products, and enzymes as well as low-molecular-weight antigens such as isocyanates, woods, antibiotics, glues, epoxies colophony products, and dyes presenting a risk. In food processing, main allergen sources can include raw and processed animal and plant products, additives and preservatives, contaminants from microbes or insects, inhaled dust particles or aerosols, which can be “IgE mediated, mixed IgE-mediated and non-lgE mediated.” While some studies have been conducted on the prevalence of work-related asthma and asthma-COPD overlap, “in general, the prevalence and clinical features have been scarcely investigated,” Dr Poole said. One survey of 23,137 patients found 52.9% of adults with work-related asthma also had COPD, compared with 25.6% of participants whose asthma was not work related. To prevent asthma-COPD overlap, Dr Poole recommended tobacco cessation, reducing indoor biomass fuel use, medical surveillance programs such as preplacement questionnaires, and considering “reducing exposure to the respiratory sensitizers with ideally monitoring the levels to keep the levels below the permissible limits.” Dr Poole noted there is currently no unique treatment for asthma-COPD overlap, but it is “important to fully characterize and phenotype your individual patients, looking for eosinophilia or seeing if they have more neutrophil features and whether or not the allergy features are prevalent and can be treated,” she said. “[A]wareness is really required such that counseling is encouraged for prevention and or interventional strategies as we move forward.” For patients with features of both asthma and COPD where there is a high likelihood of asthma, treat the disease as if it were asthma, Dr Poole said, but clinicians should follow GINA GOLD COPD treatment recommendations, adding on long-acting beta-agonists (LABAs) and long-acting muscarinic antagonists (LAMAs) when needed, but avoiding LABAs and/or LAMAs without use of inhaled corticosteroids, and avoiding oral corticosteroids entirely. Clinicians should be reviewing the treatments of patients with asthma and COPD features “every 2-3 months to see how their response is to it, and what additional therapies could be used,” she said. Dr Poole reports receiving grant support from National Institute of Environmental Health Sciences, National Institute for Occupational Safety and Health, and the Central States Center for Agricultural Safety and Health at the University of Nebraska Medical Center.

Vivo 45 LS Ventilator Introduced to the US

FEB 12 2021

Breas Medical USA announced the market introduction of the Vivo 45 LS, one of the smallest, full-featured Life Support devices on the market. The Vivo 45 LS is cleared by the US FDA to provide both invasive and non-invasive continuous or intermittent ventilatory support across the continuum of care in the home, post-acute, hospital and portable applications for pediatric through adult patients weighing more than 5 kg (11 lbs). “The ultra-portable Vivo 45 LS life support ventilator is designed to maximize independence and mobility to the patient thanks to its ultra-small footprint, utilizing the comfortable eSync trigger technology used in the Vivo 65 with added ultra-quiet operation,” said Chris Southerland, General Manager, Breas Americas. “The Vivo 45 LS has the added benefit of offering patient monitoring of etCO2, SpO2, FiO2 and PtCO2 and can be connected to EveryWare, Breas’ securely hosted, remote cloud-based application, which can help deliver an insightful approach to the care of respiratory patients in the home.” Engineered in our founding Swedish and USA offices, Breas delivers leading edge innovations that can provide patient comfort and mobility needed to improve their quality of life. To learn more about the exclusive eSync™ technology, ultra-quiet operation, long battery life and integrated ventilation monitoring value for patients and caregivers alike visit Breas Medical was founded in Gothenburg, Sweden in 1991 and has provided innovative respiratory medical device products to the global market for 30 years. Breas has long been known for its Swedish design, reliable technology and ease of use. Breas offers a comprehensive line of respiratory medical devices in Homecare Life Support Ventilation and Non-Invasive Ventilation, Airway Clearance and CPAP treatment.

New Study in Newborns Finds Nellcor Pulse Oximetry Technology Provides Fast Stable Oxygen Saturation Readings

FEB 9 2021

Medtronic announced the results of an independent, prospective observational study comparing the efficacy and reliability of two pulse oximeters — Nellcor Bedside SpO2 Patient Monitoring System and Masimo Radical-7 Pulse CO-Oximeter, both set at the highest sensitivity ("Neonatal" and "Fast" for Nellcor pulse oximetry technology and "Max" for Masimo) — with electrocardiography (ECG) monitoring following the delivery of 60 term newborns by Caesarian section. Pulse oximetry is a simple, noninvasive bedside test that can accurately detect the percentage of blood saturated with oxygen and measure heart rate. According to the study, a stable signal was obtained from all 60 newborns with the Nellcor pulse oximeter but from only 55 newborns with the Masimo pulse oximeter. Of the 55 newborns with stable signals from both monitors, the mean time to stable signal with the Nellcor pulse oximeter was 15 seconds compared with 27 seconds with the Masimo pulse oximeter. The average difference of 12 seconds between the monitors was statistically significant (P <0.001). The results of this prospective observational comparative study were published online in the Journal of Perinatology, the official journal of the Section on Neonatal-Perinatal Medicine of the American Academy of Pediatrics and the Neonatal-Perinatal Association of the United States. The study was conducted at the Rabin Medical Center, Petach Tikvah, Israel, a university-affiliated tertiary care center with approximately 9,000 births annually. The principal investigator of the study is Professor Ruben Bromiker, MD, Department of Neonatology, Schneider Children's Medical Center of Israel, Petach Tikvah, Israel and Sackler Faculty of Medicine, Tel Aviv University, Tel Aviv, Israel. The availability of a pulse oximeter for monitoring oxygenation and heart rate of newborns contributes to decision making during resuscitation and stabilization, and can help physicians minimize the risk of either too low or too high blood oxygen levels and associated morbidity and mortality, the authors state in the discussion section. Both the Nellcor and Masimo pulse oximeters provide relatively quick measurements of oxygen saturation and heart rate in most cases well before the so-called "golden first minute" of resuscitation. The results conclude that Nellcor showed a statistically significant difference in the time needed to deliver a stable signal between devices which could potentially impact the provision of care during neonatal resuscitation. With respect to heart rate, the study observed there was a difference of 12 beats per minute (BPM) between the Masimo monitor and the reference standard ECG in 18 of 51 (35%) newborns. In all 18 newborns, the ECG showed a heart rate >100 BPM versus <100 BPM with the Masimo monitor, which may be observed as false bradycardia with the Masimo device. In 16 of the 51 (31%) newborns, the difference in heart rate with the Masimo monitor was 40 BPM compared with the rate recorded by the comparator ECG. In contrast, the heart rate detected by the Nellcor pulse oximetry monitor correlated closely with that of the ECG, with no recording of false bradycardia and no reading having >40 BPM difference compared with the ECG. "A newborn's heart rate is a key component of physician assessment for resuscitation, and helps to identify not only those in need of intervention but also their response to treatment. Those who do not achieve a heart rate of 100 beats per minute by five minutes of life are at an increased risk of death," said Frank Chan, president, Patient Monitoring, which is reported as part of the Minimally Invasive Therapies Group at Medtronic. "This study demonstrates that physicians can rely on Nellcor pulse oximetry technology to post data quickly, offer consistency, perform well with these patients, and meet the requirements of the neonatal resuscitation program guidelines, which are especially important in the delivery room." These findings are important because, per the neonatal resuscitation program (NRP) guidelines, only one minute should be allotted for completing the initial monitoring steps to inform reevaluation and initiation of ventilation.

Device Gets Clearance

FEB 01 2021

3B Medical, Inc. announced receiving FDA 510(k) clearance on its new third generation bi-level device, the Luna G3 Auto-BPAP. The Luna G3 Auto BPAP is a modern and technologically advanced Bi-Level PAP therapy device for the treatment of obstructive sleep apnea. This device is available with integrated heated tubing, cellular connectivity and 3B's advanced algorithm which automatically senses and adjusts pressure settings to ensure airway patency for a comfortable night's sleep. The Luna G3 Auto-BPAP provides a backup rate that reduces the work of breathing with pressure settings up to 25 cmH20. "We are excited by FDA's recent action approving use of the Lumin G3 Auto-BPAP. The Luna G3 is 3B Medical's third generation platform and incorporates a new design, a smaller footprint, and more advanced functionality", said Justin Smith, 3B Medical's Chief Operating Officer. The Luna G3 Auto-BPAP delivers non-invasive ventilator support with all of the bells and whistles that DME's have come to expect from 3B Medical", said Smith. 3B Medical is a leader in the development, marketing and distribution of medical products for the treatment of sleep therapy, oxygen therapy and disinfection

Maternal COVID Antibodies Cross Placenta, Detected in Newborns

JAN 29 2021

Antibodies against SARS-CoV-2 cross the placenta during pregnancy and are detectable in most newborns born to mothers who had COVID-19 during pregnancy, according to findings from a study presented at the virtual Society for Maternal-Fetal Medicine (SMFM) 2021 Annual Pregnancy Meeting. "I think the most striking finding is that we noticed a high degree of neutralizing response to natural infection even among asymptomatic infection, but of course a higher degree was seen in those with symptomatic infection," Naima Joseph, MD, MPH, of the Emory University School of Medicine, Atlanta, Georgia, said. "Our data demonstrate maternal capacity to mount an appropriate and robust immune response," and maternal protective immunity lasted at least 28 days after infection, Joseph said. "Also, we noted higher neonatal cord blood titers in moms with higher titers, which suggests a relationship, but we need to better understand how transplacental transfer occurs as well as establish neonatal correlates of protection in order to see if and how maternal immunity may also benefit neonates." The researchers analyzed the amount of immunoglobulin G (IgG) and immunoglobulin M (IgM) antibodies in maternal and cord blood samples prospectively collected at delivery from women who tested positive for COVID-19 at any time while pregnant. They used enzyme-linked immunosorbent assay to assess for antibodies for the receptor binding domain of the SARS-CoV-2 spike protein. The 32 pairs of mothers and infants in the study were predominantly non-Hispanic Black (72%) and Hispanic (25%), and 84% used Medicaid as their payer. Most of the mothers (72%) had at least one comorbidity, most commonly obesity, hypertension, and asthma or pulmonary disease. Just over half the women (53%) were symptomatic while they were infected, and 88% were ill with COVID-19 during the third trimester. The average time from infection to delivery was 28 days. All the mothers had IgG antibodies, 94% had IgM antibodies, and 94% had neutralizing antibodies against SARS-CoV-2. Among the cord blood samples, 91% had IgG antibodies, 9% had IgM antibodies, and 25% had neutralizing antibodies. "It's reassuring that so far, the physiological response is exactly what we expected it to be," Judette Louis, MD, MPH, an associate professor of ob/gyn and the ob/gyn department chair at the University of South Florida, Tampa, Florida, said. "It's what we would expect, but it's always helpful to have more data to support that. Otherwise, you're extrapolating from what you know from other conditions," said Louis, who moderated the oral abstracts session. Symptomatic infection was associated with significantly higher IgG titers than asymptomatic infection (P = .03), but no correlation was seen for IgM or neutralizing antibodies. In addition, although mothers who delivered more than 28 days after their infection had higher IgG titers (P = .05), no differences existed in IgM or neutralizing response.

Benralizumab Improves Health-Related Quality of Life in Severe Eosinophilic Asthma

JAN 29 2021

Severe eosinophilic asthma can cause airway hyperresponsiveness, worsening symptoms, and decreased lung function for patients, often leading to recurrent or maintenance corticosteroid use and deeply conditioning patients’ quality of life. A team, led by Carla Maria Irene Quarato, University of Foggia, determined if and how an add-on treatment with benralizumab could improve the quality of life of patients with severe eosinophilic asthma in data at the European Respiratory Society International Congress 2020 (ERS 2020). The study included 10 outpatients with severe eosinophilic asthma, 7 of which were female. Each patient received treatment added-on with benralizumab and was followed-up with in an accredited outpatient clinic for severe asthma at 12 and 24 weeks. The investigators assessed quality of life during each visit using the Asthma Quality of Life Questionnaire (AQLQ), EuroQol-visual analogue scales (EQ-VAS), and EuroQol-5Dimensions-3Levels (EQ-3D-5L). The researchers found both a significant reduction in eosinophilic inflammation, exacerbations, and gaining in pre-bronchodilator FEV1 and symptoms control, with all the enrolled subjects experiencing an improvement in AQLQ [from 3.65±0.56 (baseline) to 4.61±0.67 (12 weeks) (P = 0.003) and to 5.17±0.87 (24 weeks) (P = 0.0002)]. This covered all 4 health domains—symptoms perception, activity limitation, emotional function, and environmental stimuli—investigated (P <0.05). The patients also saw an improvement in EQ-VAS (from 44.5±7.7% (baseline) to 60.5±6.6% (12 weeks) (P = 0.002) and to 86.7±7.2% (24 weeks) (P <0.001), with a statistically significant reduction in severe limitation in all dimensions—mobility, self-care, daily activities, pain/discomfort and anxiety/depression (P <0.001). “Our real life experience confirms the effectiveness of benralizumab as an add-on treatment in restoring patients with severe eosinophilic asthma to a better [quality of life] perception already after 12 weeks of treatment,” the authors wrote. Recent study findings from the ANDHI trial further back the efficacy and safety of benralizumab for patients with severe asthma. The study extended knowledge and understanding of the efficacy and safety of benralizumab for severe eosinophilic asthma patients, including the onset of effect and additional health-related quality of life measures. They included adult patients with severe eosinophilic asthma with at least 2 prior-year exacerbations despite high-dosage inhaled corticosteroid plus additional controllers and screening blood eosinophil counts of at least 150 cells/µL. Patients were randomized 2:1 to either 24 weeks of benralizumab 30 mg every 8 weeks or placebo. Nasal polyposis was present for 34.2% of those in the benralizumab group and 35.8% of placebo patients, with a mean SNOT-22 of 51.5 for benralizumab versus 48.2 for placebo. The team found benralizumab significantly improved asthma exacerbation rate, with a 49% reduction versus placebo (.94 vs 1.86; P <.0001). There was also a clinically meaningful and statistically significant improvement in least-squares mean change in SGRQ total score at week 24 versus placebo (delta-8.11; P <.0001), with similar differences at earlier times throughout the study period. Benralizumab improved lung function, ACQ-6, and SNOT-22 at week 24 versus placebo.

Asthma-COPD Overlap: Patients Have High Disease Burden

JAN 29 2021

Patients with asthma–chronic obstructive pulmonary disease overlap (ACO) experienced a higher burden of disease than patients with either asthma or COPD alone, a recent study has found. Approximately 20% of chronic obstructive airway disease cases are ACO, but data on these patients are limited, as they are often excluded from clinical trials, wrote Sarah A. Hiles, MD, of the University of Newcastle (Australia) and colleagues. “Comparing the burden of eosinophilic ACO, eosinophilic severe asthma, and eosinophilic COPD may also help contextualize findings from phenotype-targeted treatments in different diagnostic groups, such as the limited success of anti-IL [interleukin]–5 monoclonal antibodies as therapy in eosinophilic COPD,” they said. In a cross-sectional, observational study published in Respirology the researchers recruited patients aged 18 years and older with a confirmed diagnosis of COPD only (153) severe asthma only (64), or ACO (106). Patients were assessed for demographic and clinical factors including health-related quality of life, past-year exacerbation, and other indicators of disease burden. In addition, patients were identified as having eosinophilic airway disease based on a blood eosinophil count of at least 0.3x109/L. Overall, eosinophilic airway disease was present in 41% of the patients; 55%, 44%, and 29% for those with ACO, severe asthma, and COPD, respectively. Reports of poor health-related quality of life and past-year exacerbations were similar for eosinophilic patients across all three conditions. However, patients with eosinophilic ACO experienced significantly more past-year exacerbations, notably those requiring oral corticosteroids, compared with patients with asthma alone. In addition, the cumulative number of past-year exacerbations in patient with eosinophilic disease was 164 in those with ACO, compared with severe asthma alone (44) and COPD alone (59). Patients with ACO also had significantly higher disease burden based on the St. George’s Respiratory Questionnaire (SGRQ), which assessed functional limitation. “For 100 patients, the cumulative SGRQ score attributable to eosinophilic airways disease in ACO was 2,872.8, which was higher than in severe asthma (1,942.5) or COPD (1,638.1),” the researchers said. The study was limited by several factors including the cross-sectional design and use of a single measurement to classify eosinophilia, the researchers noted. “The non-eosinophilic group likely included a mix of patients with treated eosinophilia and patients without eosinophilia, regardless of treatment, which is a limitation to consider when interpreting the disease burden estimates in this group,” they added. However, the results add to the understanding of blood eosinophils in airway disease and the study “supports eosinophilia as a phenotype that spans across disease labels of severe asthma and COPD, and their overlap,” they concluded. The study was supported by AstraZeneca; lead author Dr. Hiles received a salary through a grant from AstraZeneca to the University of Newcastle while conducting the study. Other coauthors disclosed relationships with companies including AstraZeneca, GlaxoSmithKline, Menarini, and Novartis.

Asthma-COPD Overlap: Patients Have High Disease Burden

JAN 16 2021

Patients with asthma–chronic obstructive pulmonary disease overlap (ACO) experienced a higher burden of disease than patients with either asthma or COPD alone, a recent study has found. Approximately 20% of chronic obstructive airway disease cases are ACO, but data on these patients are limited, as they are often excluded from clinical trials, wrote Sarah A. Hiles, MD, of the University of Newcastle (Australia) and colleagues. “Comparing the burden of eosinophilic ACO, eosinophilic severe asthma, and eosinophilic COPD may also help contextualize findings from phenotype-targeted treatments in different diagnostic groups, such as the limited success of anti-IL [interleukin]–5 monoclonal antibodies as therapy in eosinophilic COPD,” they said. In a cross-sectional, observational study published in Respirology the researchers recruited patients aged 18 years and older with a confirmed diagnosis of COPD only (153) severe asthma only (64), or ACO (106). Patients were assessed for demographic and clinical factors including health-related quality of life, past-year exacerbation, and other indicators of disease burden. In addition, patients were identified as having eosinophilic airway disease based on a blood eosinophil count of at least 0.3x109/L. Overall, eosinophilic airway disease was present in 41% of the patients; 55%, 44%, and 29% for those with ACO, severe asthma, and COPD, respectively. Reports of poor health-related quality of life and past-year exacerbations were similar for eosinophilic patients across all three conditions. However, patients with eosinophilic ACO experienced significantly more past-year exacerbations, notably those requiring oral corticosteroids, compared with patients with asthma alone. In addition, the cumulative number of past-year exacerbations in patient with eosinophilic disease was 164 in those with ACO, compared with severe asthma alone (44) and COPD alone (59). Patients with ACO also had significantly higher disease burden based on the St. George’s Respiratory Questionnaire (SGRQ), which assessed functional limitation. “For 100 patients, the cumulative SGRQ score attributable to eosinophilic airways disease in ACO was 2,872.8, which was higher than in severe asthma (1,942.5) or COPD (1,638.1),” the researchers said. The study was limited by several factors including the cross-sectional design and use of a single measurement to classify eosinophilia, the researchers noted. “The non-eosinophilic group likely included a mix of patients with treated eosinophilia and patients without eosinophilia, regardless of treatment, which is a limitation to consider when interpreting the disease burden estimates in this group,” they added. However, the results add to the understanding of blood eosinophils in airway disease and the study “supports eosinophilia as a phenotype that spans across disease labels of severe asthma and COPD, and their overlap,” they concluded.

Asthma Inhaler Sensors Improve Pediatric Asthma Control

JAN 16 2021

Sensor-based inhaler monitoring with clinical feedback may improve asthma symptom control in children, as well as caregiver quality of life, according to a randomized trial evaluating a sensor-based electronic monitoring system. Such a system would work well in racially and economically diverse pediatric populations, researchers found. However, this intervention was also associated with higher health care usage, suggesting that further “platform refinement” is warranted. The study, from Ruchi S. Gupta, MD, MPH, Feinberg School of Medicine, Northwestern University, Chicago, Illinois, and colleagues, was published in Pediatrics. One of the issues associated with managing asthma in school aged children is adherence to preventive therapies such as daily inhaled corticosteroids (ICS) — And poor adherence leads to complications. For example, research shows that about 1 out of every 4 asthma exacerbations and more than half of asthma-related hospitalizations are due to nonadherence to ICS. The need to improve ICS adherence among children has resulted in interventions involving sensor-based inhaler monitoring, giving clinicians the chance to assess and intervene on the basis of real-time adherence and usage data. Furthermore, Gupta and colleagues pointed out, “the integration of sensor-based inhaler monitoring with mobile applications may reduce asthma-related health care use by assisting asthma patients between health care provider visits.” The Improving Technology-Assisted Recording of Asthma Control in Children (iTRACC) trial was designed to determine the effectiveness of clinically-integrated, sensor-based inhaler monitoring on symptom control and outcomes in racially and socioeconomically diverse children with moderate-to-severe asthma. Children were eligible for inclusion in the study if they were 4 to 17 years of age, had moderate-to-severe persistent asthma, had a prescription for daily ICS for 1 or more years before enrollment, and at least 1 exacerbation requiring oral corticosteroids the year before trial enrollment. In this study, 125 caregiver and child pairs were randomly assigned to inhaler sensors that allowed for caregiver and clinician electronic monitoring of medications, while 127 pairs served as controls. One primary end point of the study was the change in asthma symptom control as measured by the Asthma Control Test (ACT), a five-item questionnaire, with scores ranging from a low of 5 for poorly controlled asthma, to 25 for well-controlled asthma, and the Childhood Asthma Control Test (c-ACT), a 7-item validated questionnaire for children aged 4 to 11 years, with scores ranging from 0 for poor asthma control to 27 for well-controlled asthma. Any score under 19 on either test indicated uncontrolled asthma. The other primary end point was health care usage, which included emergency department visits, hospitalizations, and oral corticosteroid prescriptions during the course of the 12-month trial. Daily ICS use and caregiver quality of life (QoL) were also assessed. Gupta and colleague found that by the end of the trial the mean adjusted ACT scores increased from 19.1 to 21.8 in the intervention group (a 2.7-point increase), and from 19.4 to 19.9 in the control group (a .5 point increase). They also found the change in adjusted mean ACT scores from baseline was significantly greater in the intervention group than in controls at all time points of the trial, with the greatest difference at 12 months.

Grant Issued to Develop Vaccine

JAN 11 2021

GeoVax Labs, Inc., a biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, announced that the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), has awarded the company a Small Business Innovative Research (SBIR) grant in support of its development of a vaccine against SARS-CoV-2, the virus that causes COVID-19. The Phase 1 grant, titled, “Preclinical Development of GV-MVA-VLP Vaccines Against COVID-19,” will support the ongoing design, construction and preclinical testing of GeoVax’s vaccine candidates in preparation for human clinical trials. The efficacy testing will be performed in collaboration with the University of Texas Medical Branch (UTMB). GeoVax is leveraging its GV-MVA-VLP platform to address the global need for an effective and safe SARS-CoV-2 vaccine. Unique among other vaccines under development, the experimental GeoVax candidates are specifically designed to provide a broader and more long-lived level of protective immunity against SARS-CoV-2 while avoiding the potential side effects that can limit vaccine utility and acceptance. GeoVax’s vaccine candidates will be tested for antigen expression and genetic stability under conditions designed to simulate those in manufacturing, which will demonstrate the likely suitability of each vaccine construct as a candidate for full-scale production and clinical testing. Mark Newman, Ph.D., GeoVax’s Chief Scientific Officer, commented, “The first generation of SARS-CoV-2 vaccines are based on the ‘Spike (S)’ protein and are designed to induce antibodies that block infection of human cells, an effect referred to as virus neutralization. The GV-MVA-VLP platform provides the opportunity to design and test vaccine candidates that differ significantly through the inclusion of multiple SARS-CoV-2 proteins that are presented to the immune system as virus-like particles (VLPs). Our goal is to safely increase vaccine potency and efficacy by inducing both neutralizing antibody and cellular immune responses to optimize the level of protection against existing and potential new variants of COVID as well as establish immunological memory to provide multi-year protection. Vaccines using the GV-MVA-VLP platform developed for other pathogens have proven to be efficacious with a single dose, having strong durability which would be a significant advantage for SARS-CoV-2 global vaccination campaigns.” David Dodd, GeoVax’s Chairman and CEO, added, “We are pleased to receive this Phase 1 SBIR funding award, which will supplement the internal resources allocated to our COVID-19 vaccine program and accelerate our progress toward human clinical trials. We appreciate and welcome this support from NIH/NIAID, which follows our signing of a Patent and Biological Materials License Agreement providing GeoVax with access to key NIAID patent rights, and which provides GeoVax with nonexclusive rights to develop, manufacture and commercialize our COVID-19 vaccine. While we continue to advance our COVID-19 vaccine program, we remain in discussions and negotiations related to additional funding support that will further accelerate our progress into clinical testing and supply chain preparation. We anticipate that additional vaccines, such as ours will be necessary against COVID-19, as well as potentially new strains and variants, requiring broader immune response, strong durability, exquisite safety within various cohort populations and minimal refrigeration for distribution and supply throughout the world. These attributes represent the focus of our overall ‘COVID-X’ vaccine program (think ‘COVID-20, -21’, etc.).”

Mercury Medical Announces New Director of Sales

JAN 11 2021

Mercury Medical, Inc., has announced the appointment of David L. McLaughlin as Director of Sales - Western Region. McLaughlin will be responsible for increasing the sales growth of Mercury's products in the Western United States and galvanizing the sales infrastructure to better serve this essential customer base. "We are delighted to have David join the company at this juncture. Our product pipeline in the critical care markets has never been stronger. David is an 18-year veteran in our industry and previously worked at Mercury Medical as a Territory Sales Manager before joining Edwards Lifesciences in 2010. David brings significant commercial experience to Mercury Medical, which will be of great benefit for our customers," said Executive Vice President - Sales and Marketing, Ray Mundy. While at Edwards Lifesciences, McLaughlin held various leadership positions and was instrumental in developing strategic methodologies for sales and clinical training. "I am honored again to be joining Mercury Medical as their Director of Sales - Western Region. My focus will be on doing what is best for our customers and providing leadership and enhanced training to the sales organization," said McLaughlin. Mercury Medical is a global provider of medical device systems for healthcare providers bringing a legacy of innovation through high quality, cost-efficient solutions for better patient outcomes. As both a manufacturer and distributor, the company provides its products to critical care, neonatal, anesthesia, and EMS markets in more than 58 countries.

Company Signs Distribution Agreement

JAN 10 2021

Dräger, an international leader in the fields of medical and safety technology, today announced that it has entered into an agreement with Breas Medical, a global medical device company delivering respiratory care solutions throughout the continuum of care. Together, they will provide long-term acute care (LTAC) and skilled nursing facilities (SNF) in the US access to both Dräger and Breas Medical mechanical ventilator technologies. Both Dräger and Breas Medical offer solutions specifically designed to address the challenges faced by many LTACs and SNFs, most notably the complexity and costs associated with caring for chronically ill patients after requiring mechanical ventilation following intensive care. This new agreement with Breas Medical, effective January 6, 2021, will extend the reach of high-quality ventilation, along with the company’s unparalled service and support, into these and other non-acute settings. “In an effort to reduce costs, the care of stable but chronically ill patients is increasingly being pushed from the hospital out to extended care settings with many of these patients relying on mechanical ventilation,” said Dräger Senior Vice President of Sales, Hospital Solutions, Steve Menet. “Administrators at these alternative care facilities continue to deliver quality care with limited resources. This distribution agreement with Breas Medical offers a more comprehensive solution with the combined goals of positively impacting patient and financial outcomes.” “Quality and patient comfort are Breas’ top priority; we put great focus into these core values using innovation in all of our devices. This agreement with Dräger will improve the experience for patients, operators and clinicians while creating more effective access and support for Breas ventilators in the LTAC and SNF markets,” said Chris Southerland, General Manager of Commercial Operations, Americas Region at Breas Medical. “Dräger is known throughout the healthcare industry and respiratory community for its state-of-the art mechanical ventilation technology. We are proud to partner with Dräger in their efforts to care for more clinically complex patients.”

AerosoLess Medical Has Introduced a New Nebulizer Mask

JAN 8 2021

According to a recent estimate, more than 2,900 US healthcare workers have died in the COVID-19 Pandemic since March 2020. The gravity of the pandemic has heightened awareness of the necessity of preventing patients’ pathogens from infecting front-line medical personnel. In the case of nebulizers, which are the recommended treatment protocol for medical conditions where patients present with shortness of breath, the pandemic has compromised physicians’ options in treating their patients. Nebulizers are being underused due to concerns that they facilitate the spreading of patient-generated viral particles into the environment. AerosoLess Medical is producing the SafetyNeb, an aerosol delivery device fitted with water-resistant viral filters over its vent holes. These highly effective viral filters are designed to prevent both patient exhaled pathogens and fugitive emissions from entering into the environment and thereby endangering Healthcare Workers. In addition to the viral filters, the SafetyNeb uses patent-pending technology to create a CPAP-like tight seal with the patient’s face. Unlike other devices which were designed primarily for optimizing the delivery of aerosolized medications, the AerosoLess SafetyNeb was designed from the very beginning with the utmost focus on protecting the safety of healthcare personnel without compromising medication delivery. The unique design of the SafetyNeb drastically reduces the ability of pathogens contained in patients’ exhaled breath and coughs to escape into the environment

Capsule and Retia Medical Collaborate on Argos Cardiac Monitor

JAN 05 2021

Retia Medical is the first company to utilize Capsule Technologies’ new Device Driver Interface (DDI) development strategy to integrate its Argos Cardiac Monitor, the companies announced. Capsule’s new DDI development strategy uses the Integrating the Healthcare Enterprise-Patient Care Device (IHE-PCD) framework to speed device connectivity to other systems, improve clinician workflow efficiency, and to protect patient safety through rapid and accurate identification. IHE is a consortium of healthcare and industry experts focused on improving healthcare information sharing. The IHE framework fills the gaps between device communication standards such as HL7 without site-specific interface development so hospitals can more easily connect devices to their IT networks and capture data that drives safe and effective clinical decisions. “Medical devices, such as Retia Medical’s Argos Cardiac Monitor, are indispensable for delivering safe and high-quality patient care,” said John McHutcheon, vice president of operations at Capsule Technologies. “Yet effectively capturing and protecting the data generated from these life-saving devices, while enabling them to access EHR data, can be complicated. That is why we are very pleased to collaborate with Retia Medical on this first utilization of our Device Driver Interface that helps speed the development of highly interoperable, easily connected medical devices using an industry-recognized standard.” By leveraging the new DDI development strategy, Retia Medical expedited the integration of its updated Argos Cardiac Monitor, saving engineering time and improving customer satisfaction. Using this strategy also enables the Argos Cardiac Monitor to take advantage of Capsule Technologies’ Rapid Patient Identification (RPI) capability, which empowers clinicians at the point of care to more rapidly send patient demographic information to the device for faster identification confirmation, streamlining workflows, and promoting safer care. Likewise, the agreement with Capsule also supports Retia Medical’s ability to develop its device output following Rosetta Terminology Mapping (RTM) and to receive patient demographics on its device using an IHE Patient Demographics Query (PDQ) request. Incorporating RTM and IHE profiles improves the interoperability of Retia Medical’s device across a variety of different IT systems while also enabling clinicians to identify patients accurately and easily to protect their safety. “Our vision is to help prevent cardiovascular and other major complications from surgery and critical care by providing consistently accurate hemodynamic data to guide diagnosis and therapy. A key component of this approach is to help implement physiology-based, data-driven protocols through streamlined connectivity to the electronic health record (EHR) using modern communication protocols,” said Marc Zemel, co-founder and CEO of Retia Medical. “We are pleased to collaborate with Capsule to make this vision a reality.”

Children With Exercise-Induced Respiratory Symptoms May Get Conflicting Diagnosis


Children referred to outpatient clinics for exercise-induced respiratory symptoms often get a diagnosis that differs from the one they received from their primary care provider, a Swiss study suggests. Researchers examined data on a cohort of 214 children up to 16 years old who were referred from primary care to specialists for exercise-induced respiratory symptoms. Overall, the final diagnosis after outpatient clinic consultations differed from the original diagnosis in primary care in 115 (54%) of the cases. “Exercise-induced respiratory symptoms can have different underlying causes, and the distinction is often not easy, because signs and symptoms overlap,” said senior study author Dr Claudia Kuehni of the Institute for Social and Preventive Medicine at the University of Bern in Switzerland. Several problems can co-exist in the same child, such as asthma and dysfunctional breathing, Dr Kuehni said by email. “A definite diagnosis often needs several visits to a doctor, and sometimes specialized investigations, or repeated tests, such as repeated lung function tests,” Dr Kuehni said. “A clinical history alone is often misleading.” Children in the study were 12 years old on average and ranged in age from 2 to 17 years. More than half (59%) were referred to specialists with a diagnosis of asthma in primary care. Another 12 children (6%) were referred for dysfunctional breathing, and 74 (35%) were referred to specialists without a formal diagnosis from their primary care provider. After specialist visits, the most common final diagnosis was asthma (54%). Other common final diagnoses included extrathoracic dysfunctional breathing (16%), thoracic dysfunctional breathing (10%), asthma plus dysfunctional breathing (11%), insufficient fitness level (5%), and chronic cough (3%). The final diagnosis matched the initial diagnosis in primary care most often for children with asthma plus dysfunctional breathing (70%), and least often for children with thoracic dysfunctional breathing (32%). Prior to referral to specialists, 65% of children were on inhaled corticosteroids or other asthma therapies. After specialist consultations, these medications were almost exclusively prescribed to asthma patients with or without dysfunctional breathing.

FDA Approves Use of Nitric Oxide Delivery System


VERO Biotech LLC, an Atlanta, Georgia-based biotechnology company focused on saving lives, alleviating suffering, and improving the health economics of care, announced that the US Food and Drug Administration (FDA) has approved use of the GENOSYL Delivery System for the administration of inhaled Nitric Oxide during interhospital patient transport and in the magnetic resonance imaging suite. The approval comprises the broadest transport label available in the mobile critical care setting. The GENOSYL DS is intended for use in the hospital 1.5 Tesla and 3.0 Tesla diagnostic imaging settings up to the 100 GAUSS line, and during ground, fixed wing, and rotary interhospital transport. Complete testing included appropriate standards per FDA and FAA requirements and  proved the GENOSYL Delivery System and transport mount could withstand the use environments of ground, fixed wing, and rotary transport;  shock and vibration testing; EMI / EMC testing; and static pull testing for crash safety. In addition, hospital transport experts were consulted, and flexibility of use was confirmed. “Providing optimal care for patients needing inhaled nitric oxide during interhospital transport has long been a challenge for physicians, nurses, respiratory therapists and ambulance transport drivers,” said Robert Newmyer, MD, Medical Director – Transport, Ann and Robert H Laurie Children’s Hospital in Chicago, Illinois. “Transport vehicles are essentially mobile intensive care units and the GENOSYL Delivery System was tested and proven effective and safe in the various environments that recreated the critical care unit.” For use in interhospital patient transport, the primary and backup GENOSYL DS console must be securely mounted within the transport vehicle per hospital/transport protocols. Prior to using the GENOSYL DS in patient transport, a cassette should be inserted into each console. Transport equipment weight should be calculated to assure transport system meets weight allowance. “VERO Biotech is committed to customer collaboration on the design and individualized transport solutions with our proprietary tankless, cassette-based GENOSYL Delivery System for inhaled Nitric Oxide,” said Brent V. Furse, CEO and President, VERO Biotech. “We are proud to have consulted and collaborated with respiratory care transport experts to best meet their patient care needs with this important advancement to support interhospital transport.” Nitric oxide is a powerful molecule proven to play a critical role in a broad array of biological functions.  In the airways, nitric oxide targets the vascular smooth muscle cells that surround the small resistance arteries in the lungs and is used in adult respiratory distress syndrome and persistent pulmonary hypertension of the neonate. Prior to the approval of the GENOSYL Delivery System, the only way to provide iNO was via large, pressurized gas cylinders and associated delivery systems.

Device Makers Chooses Company to Lead Sales Efforts


Dale Medical Products, Inc., (Dale) has been servicing customers for over 60 years with their value-based product solutions and support. Working closely with clinicians, Dale has pioneered many of the product categories within acute and post-acute/long-term patient care settings. As part of its continued growth strategy to service current and new customers, Dale has selected MedTech MedCare (MTMC) to lead Dale’s sales efforts within the USA, effective January 1, 2021. Jack Moran, Managing Partner at MTMC stated “MTMC has developed an effective, efficient team of sales professionals representing leading brands nationwide. Dale’s product portfolio is well aligned with MTMC’s core competencies and we will be able to leverage their brand recognition in generating further market expansion for Dale.” MTMC is recognized as the leader in national outsourced sales solutions, and understands the needs of today's manufacturers, supply chain and end-users. In partnership, their shared business model provides a solution that incorporates selling strategies related to clinical, financial, and operational outcomes. Their expansive team of sales executives understands the importance of delivering value-based solutions related to patient safety, readmission risks, impact of complications, patient outcomes and satisfaction. John Brezack, Dale’s President, commented “Dale has been growing steadily for the entire history of the company. We have made the decision to focus on expanding our reach, and ultimately provide our products on a larger scale in order to support clinicians and improve patient outcomes and satisfaction.” Dale Medical Products, Inc. was founded in 1961, in Sharon, Massachusetts as Baka Manufacturing Company. From a modest beginning in the home of David Kaplan, inventor of the Dale Abdominal Binder, the company has grown into an industry leader in the market niches it serves. Today, Dale resides in Franklin, Massachusetts where their corporate office and manufacturing facilities are located. Dale Medical Products, Inc. is an ISO 13485 registered company.

Ventilation Stockpile Considered Inadequate


With the COVID-19 pandemic sweeping across its shores earlier this year, the US government in April announced orders for almost $3 billion of ventilators for a national stockpile, meant to save Americans suffering from severe respiratory problems brought on by the disease. But of the 140,000 machines added since then by the government to the US Strategic National Stockpile, almost half were basic breathing devices that don’t meet what medical specialists say are the minimum requirements for ventilators needed to treat Acute Respiratory Distress Syndrome, the main cause of death among COVID-19 patients. Only about 10% are full intensive care unit (ICU) ventilators of a type that doctors and ventilator specialists say they would normally use to intubate patients suffering from Acute Respiratory Distress Syndrome or ARDS. The remainder - or about 40% - are transport ventilators normally employed for shorter periods but are considered sophisticated enough to be used long enough for ARDS patients to recover. A September study by 22 ventilator specialists published in the official journal of the American College of Chest Physicians found half the models added to the stockpile were not suitable for treating ARDS. Many of the machines don’t meet the requirements of ARDS patients and their presence in the stockpile gives “a false sense of security,” Sajid Manzoor, director of adult respiratory therapy at The Johns Hopkins Hospital in Baltimore. “The COVID patients are so sick when they have ARDS. For the patients’ benefit we really need to stick with the full ICU ventilators,” he said. A spokeswoman for the Department of Health and Human Services (HHS), which is responsible for making purchases for the national stockpile, said that an interagency task force on ventilators made recommendations on which models and quantities to procure in March, a time of “extreme projections for respiratory care needs.” With little known about COVID-19 at the time, the HHS “was preparing for the worst possible scenario,” the spokeswoman said. HHS declined to share the medical advice it relied upon in setting its minimum requirements or in selecting devices. She added that the federal government has since adjusted its response as more clinical data has become available about the treatment of COVID-19. For instance, she said, the HHS is now procuring kits to provide alternatives to intubation, such as plastic tubes that deliver oxygen into the nose. The United States is engulfed in a deadly escalation of the virus with more than 1.1 million new infections last week. The country has reported more than 268,000 coronavirus-related deaths in total since the pandemic began. There is currently no ventilator supply crisis in the United States as other treatments, including steroids, have reduced the need for intubation. HHS and manufacturers of the more basic devices said they can have a role in dealing with less acute cases of COVID.

N95 Permission Granted


3B Medical announced receiving Emergency Use Authorization from the FDA to permit use of Lumin, a UVC system, on N95 respirators during the COVID-19 pandemic. Lumin was designed to clean CPAP accessories but is also used as a multi-purpose sanitizer. The announcement by the FDA allows Lumin to be used by healthcare workers employed in nursing homes, long term acute care, ambulatory, primary care, and clinics to allow N95 re-use to stop the spread of COVID-19 and help keep frontline healthcare workers safe. UVC was first reportedly used for N95 decontamination during the COVID-19 crisis by the University of Nebraska Medical Center. Since then the CDC recognized UVC as a potential means of decontaminating N95 respirators, if the proper wavelength and UVC irradiance dose were used. While FDA has approved other systems for hospital use, the approved systems are complicated, limited to large hospitals and/or extremely expensive. Lumin is the only N95 decontamination system formally recognized by FDA for killing SARS-CoV-2 that can be purchased for under $300, and with a small enough footprint to be used safely in small offices and clinics, as well as in nursing homes. “The COVID-19 global pandemic requires novel approaches and thinking outside the box. We were starting to get inundated with calls from hospitals and nursing homes asking if Lumin was strong enough to kill SARS-CoV-2. Lumin’s total output in a single 5 minute cycle ranges up to 2,400 mJ/cm2, which studies show is sufficient to kill almost any pathogen, including SARS-CoV-2. A lot of the calls coming into our office are from Fire and Rescue departments, nursing homes and smaller community hospitals, clinics and primary care physician offices trying to keep their workers safe. Lumin is likely the only device designed for home use that is powered high enough to repurpose for this use. We are very excited to have our device authorized by FDA for this application,” said Alex Lucio, CEO of 3B Medical, Inc. N95 mask shortages have been widely reported throughout the country, and globally.

Online Training Site Launched


Vitalograph announced SpiroTutor, a new online training website launching in the US. Vitalograph says it is addressing the pervasive issue of affordable and timely training surrounding quality respiratory diagnostic testing and monitoring. SpiroTutor was developed to provide thorough and consistent training to clinicians of all skill levels online and on demand. Vitalograph says it is working to break down the barriers to effective spirometry use by including this service with their products and thereby build confidence in the clinicians using our products to make a positive impact on the patients that they serve. Through SpiroTutor, Vitalograph has the capability to provide training access to users 24/7, making training and maintaining critical skills sets easier and more convenient than ever. Furthermore, to ensure that clinicians are confident using their devices, Vitalograph is providing a free enrolment with each new device purchased. Upon the completion of the training content, a manufacturer’s certificate will be issued to the customer. Training content includes all Vitalograph diagnostic software, spirometers, respiratory monitors, and screeners. Clinicians can access their free training by registering a new Vitalograph device within 30 days of purchase at Once registered, an invitation email will be sent with log in instructions to access SpiroTutor training content. Vitalograph is committed to enhancing the customer’s clinical experience by providing this valuable resource to improve: Flexibility – Clinicians can now access courses at work or at home anytime. Courses can be started and paused if interrupted and are accessible for review for up to 90 days if needed. Accessibility – Access is easy, all that is needed is log in account and a web browser. Quality – Training improves accuracy, efficiency, and reliability. This novel tool can be used for initial training and annual competency review with a certificate to authenticate. Finances- Confident quality testing results in fewer manoeuvres and higher productivity for clinicians at the bedside. There is no additional cost for the first enrolment. Additional enrolments, group training, and live training is also available for purchase. To learn more, visit Troy Pridgeon, Executive Vice President of Sales and Operations at Vitalograph US commented: “The development of this online service will help ensure that every Vitalograph customer has timely access to product training from the start.  Vitalograph already manufactures market leading and award winning respiratory diagnostic products and this integrated service is going to make sure that all of our customers have access to resources that maximize efficient use.” “We are happy to partner with Amanda Clark, President of Carolina Diagnostic Solutions, to build this resource and believe that this initiative further solidifies Vitalograph’s position as an industry leader for respiratory diagnostics. Amanda brings more than two decades of clinical experience to make the content applicable to real life scenarios of use.” Vitalograph is a world-leading provider of top quality respiratory diagnostic devices, clinical trial services and medical equipment servicing. With a pioneering heritage of excellence spanning over half a century, Vitalograph continues to make valuable contributions to effective medical care and enhanced quality of life.

PulmOne's Complete PFT e-learning and certification program is approved for 3.0 CEU's


PulmOne announced the launch of MiniBox Academy, an innovative e-learning training and certification program approved by the AARC for 3.0 CEUs. The program is provided free of charge to all MiniBox/MiniBox+ customers. MiniBox Academy is a mobile-friendly platform accessible on computers, tablets, and smart phones. It consists of a comprehensive set of modules for independent, self-paced training of medical staff, to improve their PFT testing expertise, and ensure testing consistency, accuracy and reproducibility, as well as an outstanding patient experience. The self-paced syllabus includes 17 modules with topics such as: Respiratory System anatomy; introduction to all PFTs (FVC, lung volumes, DLCO, MVV, 6MWT, FeNO and more; optimal testing techniques for the MiniBox+ system. Most modules include how-to videos and knowledge quizzes. Upon completion of the entire set, each staff member receives a certificate of completion and 3 CEUs. For more information about the MiniBox+ visit

Come to AARC Live 2020


Dräger will have a virtual booth at AARC LIVE! 2020 which will take place November 18 and 20 and December 3 and 5, 2020. Why visit Dräger at this year's AARC? 1. Free, CRCE-accredited APRV lecture series Wednesday, November 18: Science and Clinical Research of APRV using the TCAV Method 3:45 pm - 5:15 pm CT. You can Register here or on Friday, November 20: Clinical Application and Case Studies Applying the TCAV method of APRV, 5:15 pm - 6:45 pm CT. You can Register here 2. In-depth live product demonstrations: Focused on ventilation in the neonatal, adult, and LTAC care areas along with a demonstration of Seattle PAP plus - our bubble CPAP system. Download the schedule for times and dates as well as the ZOOM links to join us. 3. Conversations with the Dräger team: Bring your ICU, NICU or LTAC questions or just stop by our virtual booth to say hello! For more information or to register for the symposia, visit this website.

Inventing Therapies that Save Lives


Swedish-Canadian researcher Christer Sinderby is the man behind Getinge’s patented Neurally Adjusted Ventilatory Assist (NAVA). Using the patient’s own respiratory drive to control ventilator assistance, NAVA has elevated mechanical ventilation to an entirely new level and helped the tiniest premature baby in the world survive. “We are talking about the ECG of breathing,” Christer says. “Using NAVA in mechanical ventilation is like adding ECG to a stethoscope when monitoring a heart. Both are based on electrical signals and more precise.” The blowing of air has powered most of Christer Sinderby’s life. In his youth, the talent for mastering the mighty sea breezes enabled him to compete with the best windsurfers in the world. As a scientist, the ability to control a few milliliters of air blown into a premature baby’s tiny lungs has earned him and his wife Jennifer Beck respect in the entire medical world. Recently, NAVA played a major role in helping a premature baby in Japan, weighing only 258 grams at birth, survive. “It goes without saying that it is hard to sync a ventilator with rapid breaths of only 2-3 milliliters of air. We have managed to use the baby’s own respiratory drive to achieve this synchronization,” Christer explains. “The beauty of NAVA is that it can help all types of patients breathe; no matter if it is a tiny premature baby weighing a few hundred grams or an overweight 90-year old.” NAVA has been used exclusively by Getinge since it was invented in the mid-1990s. Since 2003, Christer Sinderby is a scientist at the Keenan Research Centre for Biomedical Science, University of Toronto, Canada. “In principle, NAVA connects the patient’s brain to the ventilator,” Christer says. “The device uses the same electrical signal that activates the diaphragm to control the rhythm, depth and duration of our breathing. This means that the ventilator continuously is fully synchronized with the patient´s own breathing efforts.” The electrical discharge of the diaphragm is captured by a special Edi catheter; placed in the esophagus and also functions as a gastric feeding tube. “Since it is the patient’s own physiological signal that control the tidal volume and respiratory pattern, NAVA promotes lung-protective spontaneous breathing and reduces the risk of blowing to much or too little air into the lungs. NAVA simply delivers what the patient wants.” Christer adds: “With traditional mechanical ventilation it is often easier to ‘shut down’ an uncomfortable patient with sedation than to finetune the ventilator to deliver the right tidal volume and frequency. This is what we want to avoid.” Independent of air leakages, NAVA also facilitates non-invasive ventilation with nasal masks or prongs. A much more comfortable alternative than intubating the patient. Back in 1999, the innovation of NAVA was so remarkable that it was published in the prestigious Nature Medicine. “I think we are still the only researchers focusing on ventilator technology published there,” Christer says. Christer Sinderby and Jennifer Beck are still dedicated to improve the abilities of Getinge’s mechanical ventilators. “We focus on ventilation solutions that will be a reality in 5-10 years. Getinge’s patience with the long-term scope that is a necessity in medical research has paved the way for a partnership with mutual respect for the corporate and scientific perspectives,” Christer concludes.

Company Earns Another Ventilation Industry Award


Dräger, an international leader in the fields of medical and safety technology, announced that Frost & Sullivan has recognized the company as a global technology innovation leader in the ventilation industry. Frost & Sullivan selected Dräger for its 2020 Global Technology Innovation Leadership Award due to the company’s pioneering work to enhance patient safety and expedite recovery through innovative ventilator clinical protocols, continuous improvements in ventilation technology, and best-in-class services/support, training and continuing education. Furthermore, Dräger has significantly increased its ventilator production in 2020 to address the spike in demand driven by COVID-19. The COVID-19 pandemic has highlighted the essential need for ventilation in the treatment of critically ill patients, as well as the adverse events caused by the misuse of mechanical ventilators. During the pandemic, Frost & Sullivan analysts have been observing how the deployment of different types of ventilator models impact patient care. “We are honored to have been chosen by Frost & Sullivan for this prestigious award,” said President and CEO for Dräger in North America, Lothar Thielen. “We would not be where we are today without our employees’ dedication to continuous improvement in technology and services, and the support of our customers in helping us address their changing needs. Whether it is the ongoing challenges of value-based care, or the immediate needs presented by the current pandemic, we are proud to stand as a trusted partner to healthcare providers and their patients.” Frost & Sullivan acknowledged Dräger in the following areas: Ventilator technology: “Compared to other competitors’ products, Dräger’s Evita ventilator models offer superior technology benefits for both patient safety and user flexibility.” This includes invasive and non-invasive ventilation modes, advanced technologies that support lung protection and early weaning, and secured connectivity with other devices; service and support: “Dräger offers comprehensive and best-in-class services for healthcare providers with respect to ventilation along with digital solutions for connected care and data insights, which many competitors are striving to match.” This includes device maintenance, IT consulting and system integration, user training, and network-based services and analysis of device data; COVID-19: “Dräger has upheld its guiding principle ‘Technology for Life’ during the COVID-19 pandemic, helping countries around the world to maintain the functionality of critical infrastructure as well as ensuring that the demand for ventilators is met across the globe by significantly increasing its production.” Through its Intensive Care Online Network (ICON) emergency program, Dräger had made its ventilators available to hospitals in “hot spot” areas, along with online continuing education and a 24/7 real-time support. This is the third time in three consecutive evaluation cycles that Frost & Sullivan has recognized Dräger for best practices in ventilation therapy. In 2017, Dräger won the Frost & Sullivan North American Medical Ventilation Product Leadership Award, and in 2014 the Frost & Sullivan Best Practices Award in the Growth Excellence Leadership category for Mechanical Ventilation Equipment.

New Ventilator Launched for Adult and Pediatric Patients


Getinge has launched Servo-air, a high-performing ventilator intended for adult and pediatric patients in the United States. Servo-air includes both Invasive and Non-Invasive (NIV) ventilation modes, with Getinge’s unique High Flow Therapy and Servo Compass options. Designed for mobility, Servo-air does not require wall-gas and utilizes “hot-swappable” battery technology to switch power sources without restarting the unit. The included software modes allow clinicians to adapt and personalize ventilation to the patient and situation. The COVID-19 health crisis has underscored the need for personalized ventilation for critically ill patients. As the number of coronavirus cases in the US increased, the demand for and pressure on the availability of ventilation machines was highlighted. That demand, coupled with the emergence of pop-up hospitals to treat the influx of patients, has made portable, easy to operate ventilators an increasingly important requirement. “At the start of the COVID-19 pandemic, Getinge responded by increasing our ventilator production by 160% to help offset the rapidly growing need for these machines. We are proud to introduce our latest model, which will create flexibility for hospitals, easy transportation for pop-up treatment centers and personalization in patient treatment,” said Eric Honroth, President, Getinge North America. Servo-air will provide clinicians with a much-needed, mobile additional option. The high-performing ventilator is turbine-driven, which can be transferred intra-hospital with the patient, allowing the continuation of life-saving ventilatory support without having to switch devices. Servo-air also operates with intuitive start-up and personalization of settings. Additionally, the Servo Compass interface provides continuous monitoring and tools for supporting critical lung-protective strategies. As the patient’s condition improves, Servo-air’s Automode switches between controlled and supported ventilation depending on patient effort, providing a smoother patient transition to spontaneous breathing with less staff intervention, which is safe for the patient and is less burden on the medical center. For more than 50 years, Getinge has produced high-acuity ventilators such as the Servo-u and Servo-n, and technologies that help neonates and adults breathe including NAVA and NIV. Servo-air is a high acuity, versatile, intuitive and powerful ventilator that supports the needs of critically-ill patients. To read more about our latest innovations and our full line of mechanical ventilatory support offerings, visit our website.

Aerosolized Medications Are Back


For the past six months, since the pandemic began, nebulizers have been removed from the arsenals of Emergency Medicine Physicians and Respiratory Therapists. The reason is that nebulized medications have been implicated in the spreading of viral particles into the environment. As specialties that often has to resort to improvisation in a pinch, we have come up with many inventive solutions. However, these are generally temporary and often expensive. For example, a CPAP mask with an attached viral filter costs about $35 per treatment. Surprisingly, an MDI (metered-dose inhaler) with a spacer, (currently in short supply) costs $100-$150. AerosoLess Medical of South Florida has developed and recently released a new aerosol delivery device which allows us to again provide nebulized treatments. AerosoLess Medical is producing the SafetyNeb which is fitted with viral filters over the vent holes. These viral filters are designed to prevent exhaled pathogens from endangering Healthcare Workers. Additionally, the SafetyNeb uses an engineered Faceplate to create a tight seal with the patient’s face, which also provides a CPAP-like effect. With the SafetyNeb, practitioners can finally give aerosolized medications again. Look up for more information or call 800-205-5913.

Born too early with a 50/50 chance of survival — now she helps save other premature babies


When Sabina Checketts holds her hand a certain way, the tiny scar on the back of it looks like a rocket ship. Checketts got the scar during the first few days of her life, during a tenuous struggle for survival, after she was born at 28 weeks—12 weeks prematurely. Her rocket ship scar, and a few other small ones, are marks left by lines inserted into her tiny, frail body to keep her alive.  "I don't point these out to parents," Checketts says, "but to me they're badges of honor, because I survived." The parents she's referring to are the parents of her patients. Thirty-three years after her early birth, Checketts now works as a neonatal doctor in London. Checketts decided to become a doctor at early age, when her mother routinely pointed out a man walking down the street on his way to the hospital and said, “That’s the doctor who saved your life”. That experience motivates her to be a source of positivity for the families of the babies she treats. "When I talk to parents about the fact that I was premature, there always is a sense of surprise, I think a little bit even shock, you know. Oh, oh, and you're a doctor," Checketts says. "I think it's a nice way to say to them that prematurity shouldn't be a limit on what a child can do.” "I mean, the advances we've made in even just the last 10, 15, 20 years mean the outcomes are much better than they used to be. And seeing me, who developed before that, as a newborn doctor, I give them a sense of hope and possibility, I think." Today, she uses vastly improved technologies and techniques to create better outcomes for other premature babies—and more hope for their parents. As vulnerable premature babies fight to stay alive one of the most critical issues is something most people never think twice about—breathing. A pivotal advance in neonatal medicine—and one that has a major impact in adult critical care—has been the development of better ventilators. "One of the main challenges for premature babies is with ventilation," says Checketts. "Their lungs are quite stiff when they're first born because they're so immature. They're very fragile." The ventilator that helped Checketts survive was a far cry from what she sees today when she treats premature babies. "We've gone from a mode of ventilation where you were breathing for the baby to one now where we can breathe with the baby as well," she says. One ventilation technique that breathes with the patient is called Neurally Adjusted Ventilatory Assist, or NAVA, developed by Getinge, a global leader in intensive care technology for both infants and adults. Before NAVA, ventilation technology had advanced to the point that a sensor in the breathing tube alerted when a baby was trying to breathe in, and the machine supplied a breath. But there was lag time, resulting in the machine sometimes not supplying air when the lungs called for it, or forcing air into frail lungs that were not ready for it—a problem amplified by premature babies' tendency to take short, rapid and uneven breaths.  Sherry Courtney, a director of clinical research in neonatology, who has worked with premature babies since the 1980's explains, "The diaphragm is a muscle. When it contracts, we're going to breathe. When it relaxes, we're going to exhale. So, NAVA senses the breathing using a catheter that goes down into the stomach and rests close to the diaphragm." Courtney says she's observed many babies who switch to a NAVA-enabled ventilator almost immediately become more comfortable and less irritable. Their oxygen needs decrease, as do pressure and volume requirements. Babies can be more restful and concentrate energy on the single most important thing they can do during their premature stage-grow. "We have been switching in our unit more and more to NAVA because the babies seem to love it," Courtney says.  NAVA is also approved for adults, and the features that make the technique successful for neonates translate well to adult patients. Adults on ventilators generally start with a functioning diaphragm, but it becomes weaker quickly. Getinge’s Medical Director Miray Kärnekull says that advanced ventilator technologies like NAVA are used regularly in adult patients in Europe to keep patients' diaphragm muscles active. “It’s really a groundbreaking technology”, says Kärnekull. “NAVA gives the clinician a way to personalize not only the ventilation, but also the weaning process for adult patients”. And in a very recent multicenter randomized controlled trial, results showed that patients with acute respiratory failure on NAVA spent significantly less time on the ventilator and experienced less extubation failure compared to conventional lung-protective mechanical ventilation.

Wearable, Wireless Thermometer Launched


Masimo announced the launch of the Radius T° Continuous Thermometer for consumers. Unlike spot-check, episodic thermometers, the wearable, wireless Radius T° measures body temperature continuously, seamlessly transmitting data and customizable temperature notifications to the user's smartphone – helping caregivers, such as parents, monitor loved ones' temperatures even while they sleep. Radius T° represents a paradigm shift in thermometry by making it continuous, wearable, and hassle-free. Traditional periodic and invasive methods depend on the user repeatedly conducting a series of steps that can interrupt daily activities, including sleep, and can miss body temperature trends and patterns. With a traditional thermometer, a person may only notice a spike in temperature hours after a spike has occurred, or may not even become aware of it if it is during sleep. By contrast, Radius T° continuously and seamlessly measures temperatures using a small, inconspicuous, wearable sensor that can be easily applied to anyone from children to elderly adults – with no action needed after initial application to the skin. Radius T° eliminates manual measurements while providing continuous insight into changes in the user's temperature and helps users understand which way their temperature is trending. In addition, Radius T° uses proprietary algorithms to provide body temperature measurements for users five years or older that approximate oral temperature, not just external skin temperature. Radius T° provides temperature measurements with laboratory accuracy within ±0.1°C, whereas other oral thermometry solutions typically have laboratory accuracy within ±0.2°C. Earlier this year, Masimo launched Radius T° as part of the Masimo SafetyNet™ remote patient management solution, for use both in hospitals and by patients at home. Dr. Neal Fleming, M.D., Ph.D., Vice Chair for Education in the Department of Anesthesiology and Pain Medicine at UC Davis Health, commenting on his experience using Radius T°, said, "Radius T° is noninvasive and convenient for patients. I do not have to interrupt their daily activities or their sleep and it provides me continuous trend data that is a powerful guide to patient care. It makes it easier for me to recognize possible changes in their symptoms." Flexible and slim, each disposable Radius T° sensor can be worn comfortably for up to eight days, and is water resistant during shower and exercise. Users are free to carry on with their daily activities and sleep, without interruption or hassle – all while Radius T° continuously collects temperature data. Using built-in Bluetooth®, the sensor easily pairs with the Masimo Radius T° App on the user’s smartphone, providing real-time temperature values with user-definable automatic notifications (for example, when temperature exceeds a certain user-selected threshold or if it spikes), as well as detailed historical trending data, revealing the baseline and fluctuation patterns unique to each person that can help users determine whether a rise in temperature warrants action. In addition, the user-friendly Masimo Radius T° App can support multiple family member profiles and can be easily set to schedule medication reminders. Joe Kiani, Founder and CEO of Masimo, said, "We're excited to expand our growing line of consumer solutions, which includes MightySat® and Masimo Sleep™, with the Radius T° Continuous Thermometer. For years, clinicians have trusted Masimo technology to monitor patients in the hospital. With Radius T° and our other consumer solutions, we're bringing our expertise and experience in accurately and reliably measuring physiological data from the hospital to the home." Radius T° is not FDA 510(k) cleared. The device is marketed under the FDA's Enforcement Policy for Clinical Electronic Thermometers During COVID-19. Radius T° is CE marked.

Extracorporeal Life Support Refined Even More


Getinge is a world leading supplier of components to support Extracorporeal Life Support (ECLS)—a therapy that supports the function of lungs and/or a heart that have ceased working. Invented in the 1960's to facilitate heart bypass surgery, ECLS techniques and technologies have been refined to the point that they are used increasingly in Japan, Europe and, more recently, in the US. "For example, for pulmonary (lung) support, we take blood out of one of the big veins in the body," says David A. Kaufman, MD, Pulmonary & Critical Care Medicine at NYU School of Medicine in New York, US. “We then run it through a chamber where we are able to extract the carbon dioxide and put in a high concentration of oxygen. Then, that blood is injected back into another vein." ECLS is primarily a way to buy time and keep the blood oxygenated limiting the damage to the lungs in the most critical situations—like multi-organ failure—while doctors can figure out how to save the patient. The technique has potential in the case of trauma, while a patient awaits organ donations, or in the treatment of acute infectious disease, when long term utilization of a ventilator could cause damage. "There are times when a patient’s lungs are in such bad shape that the force that a mechanical ventilator needs to apply to get any gas into the lungs is very high," Dr. Kaufman says. "ECLS allows us to make sure that we're not adding to the damage that's already occurring from the patient's underlying disease." Getinge has a broad, high-end product portfolio for short-term or prolonged ECLS that includes a choice of devices and consumables to provide individual and sufficient extracorporeal heart and lung support, such as centrifugal pumps, oxygenators, heater units, tubing sets, and catheters and cannulae. During the COVID-19 outbreak, the ECLS therapy has provided support to acute care patients around the world in need of further life support than a ventilator can provide. “Globally, we have seen a rising demand for ECLS therapy related products and will continue to increase our production to help our customers save more lives”, says Lena Hagman, EVP Quality & Regulatory Compliance & Managing Director Cardiopulmonary at Getinge. “Getinge has increased production output of Heart Lung Support (HLS) Advanced Sets and Permanent Life Support (PLS) Sets this year by more than 30% at our production facility in Hechingen and 110% in Rastatt and we have ambitious plans for continued growth.” The significant investments at these manufacturing facilities in Germany, are primarily related to increased production capacity. This includes various production tools, assembly machinery, coating equipment but also significant headcount increase of production employees. “In the current health care environment, the US has also seen an increase in demand for ECLS therapy products for the acute care setting. Getinge investments in life-saving options have allowed us to meet the increased demands, such as the COVID-19 pandemic,” said Eric Honroth, Getinge President, North America. Honroth further states, “Vital equipment, such as ECLS therapy products allows the US to be prepared for future challenges.”

Device Maker Adds to its Team


Mercury Medical, a medical device manufacturer focused on airway and respiratory healthcare markets, announces the appointment of Raymond L. Mundy to the newly created position, Executive Vice President – Sales and Marketing. Mundy will be responsible for the continued sales growth of Mercury’s products throughout the United States and the global marketplace. “We are excited to have Ray join the company at a time when, more than ever, the treatment of respiratory disease demands innovative new products and solutions. Ray is a 17-year veteran in our industry, with a diverse clinical and commercial background bringing a wealth of sales and operations expertise to our Company,” said CEO, John Gargaro, MD. Mundy joins Mercury from Medtronic plc including companies that were subsequently acquired by the firm, such as Covidien during his tenure. “I am very pleased to be joining Mercury Medical as their new Executive Vice President of Sales and Marketing. The opportunities that exist both at the company and the markets they serve are tremendous. There has never been a more critical time to ensure access to Mercury’s respiratory and airway management technologies,” said Mundy. Mercury Medical is a global provider of airway and respiratory medical device systems for healthcare providers bringing a legacy of innovation, high quality lower cost solutions, and better patient outcomes. The company distributes its products into 58 countries, into critical care, neonatal, anesthesia and EMS markets.

Ventilation Technology Breaks Ground for Adults and Premature Babies


Born 12 weeks too early with a 50/50 chance at survival, Sabina Checketts has grown up to become a neonatal doctor herself, using new therapies and sophisticated technology to improve outcomes for premature babies. One such technique called NAVA, invented by Getinge, utilizes sensors to help babies on ventilators breathe more easily and naturally—and it’s increasingly being used on adults. And a new randomized study shows that NAVA can significantly shorten the time on the ventilator. Thirty-three years after her early birth, Checketts now works as a neonatal doctor in London. The ventilator that helped Checketts survive was a far cry from what she sees today when she treats premature babies. “We’ve gone from a mode of ventilation where you were breathing for the baby to one now where we can breathe with the baby as well,” she says. As vulnerable premature babies fight to stay alive one of the most critical issues is something most people never think twice about—breathing. A pivotal advance in neonatal medicine—and one that has a major impact in adult critical care—has been the development of better ventilators. One ventilation technique that breathes with the patient is called Neurally Adjusted Ventilatory Assist, or NAVA, developed by Getinge, a global leader in intensive care technology for both infants and adults. In most intensive care units 20% of patients consume 80% of ventilation resources, which may lead to increased complications and unwanted outcomes.  NAVA, is also approved for adults, and the features that make the technique successful for neonates, translates well to adult patients. “NAVA is a way to do a little better job,” says Sherry Courtney, a director of clinical research in neonatology, who has worked with premature babies since the 1980’s. “The diaphragm is a muscle. When it contracts, we’re going to breathe. When it relaxes, we’re going to exhale. So, NAVA senses the breathing using a catheter that goes down into the stomach and rests close to the diaphragm.” Electrodes on the catheter sense contractions in the diaphragm, resulting in an almost instantaneous signal that the patient wants to breathe. Synchronously, the ventilator supplies air. And when the electrodes sense the end of diaphragmatic contractions, the ventilator allows exhalation. “NAVA just provides a little support, depending on the breath the patient can be breathing as the patient wishes,” says Courtney. Adults on ventilators generally start with a functioning diaphragm, but it will quickly become weaker if a machine breathes for them for too long. Getinge Medical Director Miray Kärnekull says that advanced ventilator technologies, like NAVA, are used regularly in adult patients in Europe to keep patients’ diaphragm muscles active. And in a very recent multicenter randomized controlled trial, results showed that patients with acute respiratory failure on NAVA spent significantly less time on the ventilator and experienced less extubation failure compared to conventional lung-protective mechanical ventilation. “In addition to helping maintain the diaphragm’s tone, the synchrony of a NAVA ventilator means patients don’t fight against the ventilator,” Miray Kärnekull continues. “To prevent that, adults usually need to be sedated. With NAVA, doctors can reduce sedatives, allowing for earlier weaning with fewer complications … It’s really a groundbreaking technology”, says Kärnekull. “NAVA gives the clinician a way to personalize not only the ventilation, but also the weaning process for adult patients.” These exciting advances have allowed physicians like Checketts to celebrate even more success stories. Checketts decided to become a doctor at early age, when her mother routinely pointed out a man walking down the street on his way to the hospital and said, “That’s the doctor who saved your life.” That experience motivates her to be a positive force in the families of the babies she treats. “When I talk to parents about the fact that I was premature, there’s always a sense of surprise, I think a little bit even shock, you know. Oh, oh, and you’re a doctor,” Checketts says. “I think it’s a nice way to say to them that prematurity shouldn’t be a limit on what a child can do. I mean, the advances we’ve made in even just the last 10, 15, 20 years mean the outcomes are much better than they used to be. And seeing me, who developed before that, as a newborn doctor, I give them a sense of hope and possibility, I think.”


Bronchitis in Childhood Tied to Worse Lung Health in Adulthood


Children who suffer a bout of bronchitis at least once before their seventh birthday are at increased risk for developing lung problems such as asthma and pneumonia later in life, a study suggests. "Our findings strengthen the evidence that adult lung disease can originate in early childhood and that childhood bronchitis may adversely affect lung health in middle age," Dr Jennifer Perret of the University of Melbourne, Australia, said in a statement from the European Respiratory Society Virtual International Congress, where she presented her research September 9. Perret and her team analyzed the association between childhood bronchitis and lung problems in middle-aged adults participating in the Tasmanian Longitudinal Health Study, which has been following more than 8,500 people born in Tasmania in 1961. When they joined the study as children, their lung function was assessed and their parents provided information on whether the children had suffered asthma or bronchitis by age seven. The participants have been followed for an average of 46 years.

The researchers categorized 3,085 study participants into four groups based on parent-reported childhood bronchitis at age seven years: no bronchitis (n=1,616, 53%), non-recurrent bronchitis, with one to five episodes lasting less than a month (n=873, 28%), recurrent bronchitis, with at least six episodes lasting less than a month (n=555, 18%), protracted recurrent bronchitis, with six or more episodes lasting a month or more (n=41, 1.3%). Compared with the "no bronchitis before age seven" reference group, people who had non-recurrent, recurrent or protracted recurrent episodes of bronchitis as children had a 1.4-fold, 2-fold and 3.2-fold increased risk of pneumonia, respectively, by the time they reached the average age of 53. They also had a 1.3-fold, 2.7-fold and 6.4-fold increased risk of ever having asthma, respectively.

Disproportionate Rate of Coronavirus Deaths Found in Polluted Areas


The industrial plants in the riverside Louisiana city of Port Allen have worried Diana LeBlanc since her children were young. In 1978, an explosion at the nearby Placid oil refinery forced her family to evacuate. "We had to leave in the middle of the night with two babies," said LeBlanc, now 70. "I always had to be on the alert." LeBlanc worried an industrial accident would endanger her family. But she now thinks the threat was more insidious. LeBlanc, who has asthma, believes the symptoms she experienced while sick with the coronavirus were made worse by decades of breathing in toxic air pollution. "That is the one time in my life I thought, I'm not going to survive this," she said. "I'm going to become a statistic. I was that sick." New research shows she could well be right. COVID-19 can be made more serious — and, in some cases, more deadly — by a specific type of industrial emission called hazardous air pollutants, or HAPs, according to new peer-reviewed research by ProPublica and researchers at the State University of New York College of Environmental Science and Forestry. The study found this association in both rural counties in Louisiana and highly populated communities in New York. The analysis examined air pollution and coronavirus deaths in the roughly 3,100 U.S. counties and found a close correlation between levels of hazardous pollutants and the per-capita death rate from COVID-19. The US Environmental Protection Agency defines HAPs as chemicals known or suspected to cause cancer and other serious health problems. Under the Clean Air Act, industrial facilities emitting these pollutants are subject to regulations.

Hazardous air pollution may help explain the disproportionate number of COVID-19 deaths in communities like West Baton Rouge Parish, home to Port Allen. With 39 deaths as of Sept. 7, the parish's per-capita death rate from COVID-19 ranked it among the top 3% of all U.S. counties with at least 30 deaths. Several of its neighbors in Louisiana's industrial corridor also rank near the top of the list. Because the virus affects the respiratory system, researchers have rushed to study the potential association between mortality rates and air pollution. Early studies, including one looking at particulate matter — distinct from HAPs, but often found with them — have suggested a link.

Oral Masitinib Phase 3 Results Promising for Severe Asthma


The rate of severe asthma exacerbation was significantly reduced after 36 weeks of treatment with oral masitinib in a phase 3 randomized, placebo-controlled trial. At a dose of 6 mg/kg daily, masitinib, a tyrosine kinase inhibitor, was effective in patients with severe, persistent asthma not controlled with high-dose inhaled corticosteroids, long-acting beta agonists (LABAs), or oral corticosteroids, regardless of baseline eosinophil levels. The 240 patients in the masitinib group experienced a significant 35% reduction in the rate of severe exacerbations, compared with the 115 patients in the placebo group (rate ratio [RR), 0.64; 95% CI, 0.47 - 0.90; P = .0103). Patients with the highest dependency on oral corticosteroids — a cumulative dose of more than 1500 mg — benefited most, with a 72% reduction in exacerbations. In the subgroup of patients with a baseline eosinophil count of at least 150 cells/µL, the 181 patients in the masitinib group showed a significant 38% reduction in severe exacerbations, compared with the 87 patients in the placebo group (RR, 0.62; 95% CI, 0.42 - 0.91; P = .0156). "Overall, the safety was equivalent between the two arms — placebo and masitinib — and there was no difference in serious adverse events," said Pascal Chanez, MD, PhD, from the University of Aix-Marseille in France, who presented the study results at the virtual European Respiratory Society International Congress 2020 (ERS2020). No new safety concerns were evident during the 36-week trial, Chanez reported, adding that the team might conduct a blinded extension study out to week 96. Masitinib is different from current treatments in that those generally are targeted toward patients with higher levels of blood eosinophils, said Michael Blaiss, MD, executive medical director of the American College of Allergy, Asthma and Immunology. Blaiss was not involved in the study. The new drug has the advantage of being effective for people with high and low eosinophil counts, and is taken orally, not injected, he explained. The field welcomes an effective treatment for this population, which has high rates of emergency department use and hospitalizations, he noted. And because flare-ups can't be controlled with inhaled corticosteroids or LABAs, quality of life is diminished for these patients. Only 3% to 10% of adults living with asthma have severe disease. However, an estimated 60% of all asthma-care costs go to treating this small subset of patients, a 2017 review reports, primarily because of medication costs. "We don't have the agents out there that are efficacious for what we would call type 1 severe asthma," Blaiss said.

Study Finds Opioid-Induced Respiratory Depression in the Hospital More Common and Costly


Medtronic announced the publication of primary data from PRODIGY (PRediction of Opioid-induced respiratory Depression In patients monitored by capnoGraphY), a Medtronic-sponsored, prospective observational, multi-center study to quantify the incidence and identify patients at high risk of opioid-induced respiratory depression (OIRD), a potentially life-threatening form of respiratory compromise that may impede breathing. Importantly, conclusions from the study data enabled the development of the PRODIGY Risk Score, an easy-to-use risk prediction tool to identify patients at high risk of respiratory depression who would benefit from continuous monitoring with capnography and pulse oximetry. The study, which analyzed 1,335 patients across 16 sites in the United States, Europe and Asia, found that respiratory depression, as defined by changes in pulse oximetry and capnography monitoring parameters, occurred in 46% of medical and surgical patients evaluated who were receiving IV opioids for pain. This incidence rate is significantly higher than previously reported in clinical literature. The complete study results are published online in Anesthesia and Analgesia, the official journal of the International Anesthesia Research Society (IARS). "PRODIGY data confirms that respiratory depression in patients receiving parenteral opioids occur frequently and are potentially unknown to hospital healthcare providers," said Ashish K Khanna, MD, primary study investigator and an associate professor of Anesthesiology, section head for Research and intensivist at the Wake Forest School of Medicine. "Together with risk assessment using the PRODIGY Risk Score, the use of capnography and oximetry for continuous monitoring of patients identified as high risk for respiratory depression may increase safety when parenteral opioid analgesia cannot be avoided." Currently, there are no universally accepted guidelines to direct effective and safe assessment and monitoring practices for patients receiving in-hospital opioid analgesia. In addition to providing insight into the rate of respiratory depression, a key objective of PRODIGY was to develop and validate an accurate and easy-to-use risk assessment scoring tool. The PRODIGY Risk Score uses risk factors including: age > 60 years, male gender, opioid naïvety, sleep disorders and chronic heart disease for respiratory depression events risk prediction. "The PRODIGY Risk Score has acceptable accuracy for risk stratification using several robust methods of internal validation, addressing significant gaps in preventing this common and potentially deadly condition," said Frank Chan, vice president and general manager of the Patient Monitoring business, which is part of the Minimally Invasive Therapies Group at Medtronic. "Patients with respiratory depression were more likely to experience an adverse event that prolonged hospitalization and more likely to require rescue action, including rapid response team activation." The PRODIGY study is the largest known study using continuous capnography and pulse oximetry data on surgical and medical patients collected by Medtronic Microstream and Nellcor monitoring technology. The study design used an innovative mechanism of data collection whereby bedside providers were blinded to continuous monitoring systems and all alarms were also silenced. All patients experiencing respiratory depression were reviewed and confirmed by an independent clinical event committee of physicians with expertise in perioperative respiratory medicine.

CPAP Maker Debuts Its Softest Nasal Mask Ever


ResMed announced the launch of its AirTouch N20 nasal mask, the company’s first CPAP nasal mask with a memory foam cushion and softest nasal mask ever. AirTouch N20 uses the same patented UltraSoft memory foam cushion as the full face AirTouch F20 mask introduced in 2017. Both adapt to the curves and contours of each face, creating a soft, personalized fit designed to increase comfort and CPAP adherence. In a clinical study, 90 percent of CPAP users gave the UltraSoft foam cushion a high rating for comfort – a 4 or 5 out of 5. This unique comfort also comes with added convenience: The foam cushion doesn’t require cleaning when replaced on an appropriate schedule. Most important, AirTouch N20’s comfort and convenience can help increase patient satisfaction, adherence, and benefit from long-term therapy. Additional features include:

  • Quick-release elbow allows patients to easily disconnect from tubing without removing their mask, and magnetic clips guide the headgear to the frame quickly and easily
  • AirFit N20’s mask frame fits both AirFit N20 silicone and AirTouch N20 memory foam cushions, allowing clinicians to conveniently switch between the two during fittings or send patients home with both to see which cushion type they prefer
  • A seal designed for therapy pressures up to 30 cm H2O

“CPAP therapy should be simple, comfortable, and easy to use – and AirTouch N20 delivers on all three,” said Jim Hollingshead, ResMed president of Sleep and Respiratory Care. “The foam cushion is uniquely comfortable, adapts to give everyone a personalized fit, and doesn’t need cleaning. It’s ideal for nasal CPAP users and their providers.” AirTouch N20 is the latest in ResMed’s family of innovative CPAP masks, connected devices, and digital health technologies for helping millions with sleep apnea, COPD, and other chronic diseases sleep, breathe, and live better. AirTouch N20 is now available in the U.S., Canada, and most of Europe, with Asia-Pacific launches planned for later this year. For more information, visit

High-Frequency Oscillatory Ventilation in Infancy Shows No Lasting Benefit


Children born before 29 weeks of gestation who were given high-frequency oscillatory ventilation (HFOV) within an hour of birth have a higher risk of asthma by age 16 to 19, according to a report in The New England Journal of Medicine. The team, led in part by Dr Anne Greenough, a professor of neonatology and clinical respiratory physiology at King's College London, also found that, as young adults, the children born very prematurely tended to have substandard lung function. HFOV is designed to keep fragile lungs inflated by letting air pressure fluctuate slightly at 3 to 15 times per second. It was originally developed in Canada for neonatal intensive care units and for children. It is widely used in both populations as part of an attempt to avoid the lung damage from conventional mechanical ventilation. In 2014, a team led by Greenough found that children age 11 to 14 who had received HFOV as extremely premature infants had better lung function than babies who received conventional therapy. But when Greenough and her colleagues tested the children at age 16 to 19, "the use of HFOV in the neonatal period was not associated with superior respiratory or functional outcome." In fact, 15% of the children who had received HFOV had received a diagnosis of asthma compared with only 3% who had received conventional ventilation therapy. "We were surprised that there were five times more young people diagnosed with asthma in the HFOV group as we saw no significant differences in asthma at 11-14 years," said Greenough said. "During puberty, however, many children, particularly boys 'grow out' of asthma and this may have resulted in the changed findings." However, both groups had similar scores on the primary outcome — forced expiratory flow at 75% of the expired vital capacity. The FEF-75 z score was -1.07 with conventional ventilation and -0.94 with HFOV. "The most important message is that despite the positive effect of puberty on lung function, the majority of these very prematurely born young adults had lung function below the lower limit of normal and they require long term follow-up to determine whether they will suffer premature onset of chronic pulmonary disease," said Greenough. Asked whether the results should give doctors second thoughts about prescribing HFOV for preemies, Greenough noted, "We demonstrated no significant differences at 16-19 years in lung function, but did show significant advantages at 11-14 years of HFOV, I therefore I do not think they will have second thoughts about using HFOV for preemies — this would be likely if we had shown HFOV was associated with deleterious effects."

Screen COPD Patients With Sleep Problems for Mood Disorders


A study has shown a strong link between sleeping disturbances and depression in patients with chronic obstructive pulmonary disease. Adults with clinically stable COPD who reported sleep problems were significantly more likely to report depression or anxiety, poor self-efficacy, and poor health-related quality of life, compared with those not reporting sleep problems, according to the findings from a study of 245 patients. Sleep problems are common in patients with COPD and have been associated with poor COPD-related outcomes, wrote Sang Hee Lee, MD, of Wonkwang University Sanbon Hospital, Gunpo-si, South Korea, and colleagues. "However, there is a lack of research on factors associated with sleep disturbance in patients with COPD," they wrote. In a prospective, multicenter, cross-sectional study published in the Clinical Respiratory Journal, the researchers enrolled 245 adults with COPD who completed the COPD and Asthma Impact Scale (CASIS) to determine sleep impairment. The CASIS was developed to measure sleep-related problems associated with respiratory disease, and scored on a scale of 1-100, with higher scores indicating greater sleep impairment. The average CASIS score was 40.9. The average age of the patients was 67 years, and 92% were men. Patients' health-related quality of life, anxiety/depression, and self-efficacy were assessed using the St. George's Respiratory Questionnaire (SGRQ), the 36-item Short-Form Health Survey (SF-36), Hospital Anxiety and Depression Scale (HADS), and the COPD Self-Efficacy Scale (CSES). The average scores on these measures were 36.0 for the SGRQ; 48.1 and 50.6, respectively, for the physical and mental components of the SF-36; 3.8 and 6.4, respectively, for the HADS-A and HADS-D measures of anxiety and depression; and 3.3 on the CSES. Worse sleep in these patients was associated with worse scores on measures of mood. In a multivariate analysis, higher scores on all four measures of health-related quality of life were significantly associated with higher CASIS scores (P = .006 for SGRQ; P = .037 for SF-36, P < .001 for HADS, and P = .010 for CSES). Although the CASIS did not allow for measurement of symptom severity and did not include many items related to breathing problems, the test "shows good internal consistency, test-retest reproducibility, and construct validity according to previous studies," the researchers wrote. "The CASIS may be a good tool for evaluating sleep disturbances in COPD patients, and further study is needed," they added. The study findings were limited by several factors including the cross-sectional study design, lack of data on obstructive sleep apnea, and lack of information on specific treatments such as at-home oxygen use or high-dose steroid use, the researchers noted. However, the results were strengthened by the use of a disease-specific sleep measure, and the study is the first known to include self-efficacy in relation to sleep quality in COPD patients, they reported. The results highlight the association between depression, poor quality of life, and self-efficacy in relation to poor sleep, and suggest that "Sleep quality could be improved by enhancing HRQL and self-efficacy," the researchers said. "Screening for mood disorder in patients with COPD is also needed," they concluded.

Device Available for Clinical Trials


Vitalograph announced that their most powerful ever In2itive e-Diary is now available for clinical trials in the USA. This next generation In2itive e-Diary combines in-clinic spirometry, home monitoring of respiratory endpoints, and eCOA data gathering functions in a robust, handheld medical device. New features include: large, high resolution touch screen with clear text, animated training module and live spirometry feedback making the device easy to use and promoting high quality and reliable data; alerts, reminders and workflows are fully customizable to fit study protocols; automatic end to end secure data transmission. Fully integrated GSM module allows automatic, secure, transmission of data to the study web portal for instant access enabling real-time insight into site and subject performance. The In2itive e-Diary is a fully validated class II medical device that meets or exceeds all technical requirements for cyber-security and data protection. Vitalograph is a world leading provider of outstanding quality cardio-respiratory diagnostic devices, clinical trial services and medical equipment servicing. With a pioneering heritage of excellence spanning half a century Vitalograph continues to make valuable contributions to effective medical care and enhanced quality of life.

Device Aims to Ease Nose Irritation


3B Medical is has announced the Freedom X oxygen cannula. The Freedom X is intended to address the single most common complaint from oxygen patients, nose irritation. Constructed out of ultra-soft silicone, the patent-pending Freedom X cannula positions under the nostrils for contact free delivery of oxygen. The Freedom X is compatible with all continuous flow stationary concentrators, and is also compatible with 3B Medical’s portable oxygen concentrator, the Aer X. “Developing an algorithm for timing pulse delivery with an external cannula can get complicated. But we felt strongly that solving patient nose irritation was worth the effort. The Freedom X is a major advancement in improving the comfort of POC use for oxygen patients,” said Ted Jagger, VP of Product Development for 3B Medical. The Aer X is now available and in-stock now for ordering. The Freedom X will be available in 4 weeks.

Sleepless in the Pandemic


Sleep difficulties during the COVID-19 crisis may be exacerbated by media overexposure and other factors causing fear and stress, according to findings from a large survey of French individuals. "Physicians usually recommend coping with sleep disorders by exercising, going outside, avoiding screen time, and having a regular schedule — all recommendations difficult to apply during lockdown. Being forced to stay home and the ensuing boredom and loneliness may have led to increased [media exposure], especially among disadvantaged people and overexposure to media COVID-19 content may have contributed to fright and emotional distress," Damien Leger of the Centre du Sommeil et de la Vigilance, Hôtel Dieu APHP, Université de Paris, and his colleagues wrote in the journal Sleep. The investigators analyzed data from survey respondents about their sleep problems since the COVID-19 lockdown and other topics such as employment, daily activities, and sleep medications. The survey was part of a large research project, COCONEL, that has been developed to study the French population on a variety of behaviors and comprises 750,000 permanent panelists who respond to surveys. The survey was sent to random sample of panelists with no topic label to avoid selection bias. Of the 25,800 surveys sent, 1,005 responses were recorded. Respondents were classified as having severe sleep problems if they reported that their daytime activities were affected or if their sleeping medications had increased since the lockdown. While 73% of respondents reported poor sleep in the 8 previous days, 25% reported severe sleep problems, and 54% reported that their sleep problems had worsened during the COVID-19 lockdown. A media exposure score was created with a Likert scale (strongly agree, agree, disagree, strongly disagree) about media exposures of different types. The investigators also queried respondents about the degree to which they found media coverage of the pandemic provoked a fear response. Overall, 68% of respondents agreed that media images and stories about COVID-19 were frightening. The researchers found a strong association between severe sleeping problems and a high media exposure score (risk ratio [RR], 1.49; 95% CI, 1.10 - 2.01; P < .05). In addition, trepidation and fear from media exposure to COVID-19 news were also associated with severe sleep problems (RR, 1.27; 95% CI, 0.92 - 1.75; P < .05). "Suffering from sleep problems may have increased media use at night, and thus increased stress and/or psychological distress and reinforced sleeping problems," the investigators wrote. Not surprisingly, respondents with financial difficulties due to the pandemic also reported severe sleeping difficulties (RR, 1.99; 95% CI, 1.49 - 2.65; P < .05).

Too Many Children Receive Opioids/Steroids for Pneumonia and Sinusitis


A significant percentage of children receive opioids and systemic corticosteroids for pneumonia and sinusitis despite guidelines, according to an analysis of 2016 Medicaid data from South Carolina. Prescriptions for these drugs were more likely after visits to EDs than after ambulatory visits, researchers reported in Pediatrics. "Each of the 828 opioid and 2,737 systemic steroid prescriptions in the data set represent a potentially inappropriate prescription," wrote Karina G. Phang, MD, MPH, of Geisinger Medical Center in Danville, Pa., and colleagues. "These rates appear excessive given that the use of these medications is not supported by available research or recommended in national guidelines." To compare the frequency of opioid and corticosteroid prescriptions for children with pneumonia or sinusitis in ED and ambulatory care settings, the investigators studied 2016 South Carolina Medicaid claims, examining data for patients aged 5-18 years with pneumonia or sinusitis. They excluded children with chronic conditions and acute secondary diagnoses with potentially appropriate indications for steroids, such as asthma. They also excluded children seen at more than one type of clinical location or hospitalized within a week of the visit. Only the primary diagnosis of pneumonia or sinusitis during the first visit of the year for each patient was included. The researchers included data from 31,838 children in the study, including 2,140 children with pneumonia and 29,698 with sinusitis. Pneumonia was linked to an opioid prescription in 6% of ED visits (34 of 542) and 1.5% of ambulatory visits (24 of 1,590) (P ≤ .0001). Pneumonia was linked to a steroid prescription in 20% of ED visits (106 of 542) and 12% of ambulatory visits (196 of 1,590) (P ≤ .0001). Sinusitis was linked to an opioid prescription in 7.5% of ED visits (202 of 2,705) and 2% of ambulatory visits (568 of 26,866) (P ≤ .0001). Sinusitis was linked to a steroid prescription in 19% of ED visits (510 of 2,705) and 7% of ambulatory visits (1,922 of 26,866) (P ≤ .0001). In logistic regression analyses, ED visits for pneumonia or sinusitis were more than four times more likely to result in children receiving opioids, relative to ambulatory visits (adjusted odds ratio, 4.69 and 4.02, respectively). ED visits also were more likely to result in steroid prescriptions, with aORs of 1.67 for pneumonia and 3.05 for sinusitis. "I was disappointed to read of these results, although not necessarily surprised," Michael E. Pichichero, MD, a specialist in pediatric infectious diseases and director of the Research Institute at Rochester (N.Y.) General Hospital, said. The data suggest that improved prescribing practices may be needed, "especially in the ED," wrote Dr. Phang and colleagues. "Although more children who are acutely ill may be seen in the ED, national practice guidelines and research remain relevant for these patients." Repeated or prolonged courses of systemic corticosteroids put children at risk for adrenal suppression and hypothalamic-pituitary-adrenal axis dysfunction. "Providers for children must also be aware of the trends in opioid abuse and diversion and must mitigate those risks while still providing adequate analgesia and symptom control," they wrote.

Triple-Therapy Combo Decreases COPD Exacerbations


Phase 3 trial findings compared outcomes for COPD patients who had triple fixed-dose inhaled corticosteroid, long-acting muscarinic antagonist, and long-acting beta₂ agonist with patients who received one of two dual-therapy combinations. The results were presented at the American Thoracic Society's virtual clinical trial session. A total of 8,509 patients were randomized on a 1:1:1:1 basis to receive twice daily: Single-inhaler combinations of the inhaled corticosteroid (ICS) budesonide at one of two doses, the long-acting muscarinic antagonist (LAMA) glycopyrrolate, and the long-acting beta₂ agonist (LABA) formoterol; dual-therapy combination glycopyrrolate and formoterol; dual-therapy combination budesonide and formoterol. The annual rate of moderate or severe COPD exacerbations was 1.08 and 1.07 for the triple combinations with 320 mcg and 180 mcg doses of budesonide, respectively, compared with 1.42 for glycopyrrolate-formoterol, and 1.24 for budesonide-formoterol. Both triple combinations were significantly superior to the dual therapies for controlling exacerbations, reported Klaus F. Rabe, MD, PhD, from LungenClinic Grosshansdorf and Christian-Albrechts University Kiel (Germany), and colleagues in the ETHOS (Efficacy and Safety of Triple Therapy in Obstructive Lung Disease) trial (NCT02465567). "Our findings show the benefits of triple therapy with a budesonide-glycopyrrolate-formoterol combination over dual therapy with a LAMA-LABA or an inhaled glucocorticoid-LABA combination with respect to the annual rate of moderate or severe COPD exacerbations, symptoms, and health-related quality of life in patients with moderate to very-severe COPD who are at risk of exacerbations," they wrote in a study published online in the New England Journal of Medicine. The trial showed for the first time that "triple therapy that has half the dose of steroid compared to a standard ICS/LABA combination has had greater efficacy for the exacerbation endpoint," Rabe said during his presentation. Triple-therapy combinations with an ICS, LAMA, and LABA are recommended for patients with COPD who remain symptomatic or experience further exacerbations on dual–ICS/LABA or –LAMA/LABA combinations. The triple combinations have been shown in several studies to lower risk of exacerbations and are associated with both better lung function and health-related quality of life, compared with dual therapies, the investigators noted. However, concerns about adverse events associated with long-term ICS use — including pneumonia, cataracts, and increased fracture risk, possibly related to treatment duration, dose level, or type of corticosteroid used — spurred the ETHOS investigators to compare triple and dual fixed-dose combinations for efficacy and safety over 1 year. They enrolled 8,509 adults aged 40-80 years with symptomatic COPD (defined as score of 10 or higher on the 40-point COPD Assessment Test). All patients were receiving at least two inhaled maintenance therapies at the time of screening, and had a postbronchodilator ratio of forced expiratory volume in 1 second (FEV₁) to forced vital capacity of less than 0.7, with a postbronchodilator FEV₁ of 25%-65% of the predicted normal value. The patients all had a smoking history of at least 10 pack-years and a documented history of at least one moderate or severe COPD exacerbation in the year before screening.

Nocturnal Oxygen Therapy Reduces Hypoxemia, Apnea in COPD Patients at Altitude


COPD patients who traveled to high altitudes from low-altitude homes experienced reduced hypoxemia and sleep apnea when they were treated with nocturnal oxygen therapy, a randomized, placebo-controlled crossover trial found. The trial included 32 patients with COPD living below 800 meters with forced expiratory volume (FEV) between 30% and 80% and pulse oximetry of at least 92% who were not on oxygen therapy and had no history of sleep apnea. Researchers evaluated patients at baseline when they were at 490 meters (1,608 feet) altitude, and then during two separate stays of two days and two nights at a hotel at 2,048 meters (6,719 feet) while participants received either nocturnal oxygen therapy or a placebo treatment. Between stays in the hotel, patients spent at least two weeks back below 800 meters. Over the two nights in the hotel, patients received either nocturnal oxygen therapy or room air (placebo) administered at 3 L/min by nasal canula. At 490 meters, mean nocturnal oxygen saturation (SpO2) as measured by pulse oximetry was 92% and mean apnea-hypopnea index (AHI) measured by polysomnography was 21.6 events per hour. When patients went to 2,048 meters and received placebo treatment, mean SpO2 was 86% and mean AHI was 34.9/h. Nocturnal oxygen therapy increased SpO2 by a mean of 9 percentage points and decreased AHI by 19.7/h. "These findings are novel and clinically important as they may alter clinical practice of counselling and treating patients with COPD travelling to high altitude," said senior study author Michael Furian of the Sleep Disorders Center and the Department of Respiratory Medicine at University Hospital Zurich in Switzerland. "Nocturnal administration of supplemental oxygen may improve oxygenation, sleep-related breathing disturbances and prevent other adverse health effects," Furian said. When patients were at high altitude in the study, they got a mean of 400 minutes of sleep with nocturnal oxygen therapy, compared to 349 minutes with placebo. Compared to sleep at low altitude, placebo at high altitude was associated a decrease of rapid-eye movement sleep (mean 15.4% v 11.9%); sleep efficiency (mean 81% of time in bed v 72%); and arousal index (mean 13.7/h v 18.7/h). With nocturnal oxygen therapy at high altitude, mean rapid-eye movement sleep was 15.1%; mean sleep efficiency was 78% of time in bed; and mean arousal index was 13.8/h. Beyond its small size, another limitation of the study is that the participants all had moderate to severe COPD, and the results might not be generalizable to patients with mild or very severe COPD or to individuals who spent longer than two nights at high altitude, the study team notes in JAMA Network Open.

Socioeconomic Status Key Factor in CPAP Adherence in Older Adults


The benefits of continuous positive airway pressure therapy for patients with obstructive sleep apnea are well documented, but it only works if patients can adhere to the therapy. A large national study of older Medicare patients with obstructive sleep apnea (OSA) has identified lower socioeconomic status and comorbidities as independent risk factors for nonadherence to continuous positive airway pressure (CPAP) therapy. "[The] present results represent the largest study to date of rates and predictors of CPAP adherence among older adults in the United States. In our national sample of Medicare beneficiaries, adherence rates were generally lower than previously reported in smaller, clinic-based studies," Emerson M. Wickwire, PhD, of the Sleep Disorders Center and division of pulmonary and critical care medicine at the University of Maryland, Baltimore, and colleagues wrote in Sleep. Wickwire and colleagues estimated CPAP machine adherence using a 5% sample of Medicare claims data, identifying 3,229 Medicare beneficiaries with OSA who began CPAP therapy between 2009 and 2011. Individuals in the sample were aged at least 65 years with a new diagnosis of OSA, 88.1% of beneficiaries were white, and 52.3% were male. The researchers applied objective adherence criteria set by the Centers for Medicare & Medicaid Services, which defines CPAP adherence as a patient using CPAP for at least 4 hours on 70% of nights, or CPAP use for 21 of 30 consecutive days within 90 days after beginning therapy. Using CPAP machine charges as a measure of who adhered to therapy, they found 1,420 of 3,229 individuals (44%) achieved adherence under these criteria, which included making 13 monthly payments during their CPAP machine's "rent-to-own" period. Partial adherence was found in 997 individuals (30.9%) who made between 4-12 payments on their CPAP machine, while 812 individuals (25.2%) made 4 payments or fewer on their CPAP machines, which the researchers classified as nonadherence. Nonadherers tended to be slightly younger (mean, 72.5 years vs. 79.2 years; P < .001) and had a higher number of comorbidities (35.2% vs. 30.4%; P = .002), compared with individuals with high adherence. Anxiety (odds ratio, 1.34; 95% confidence interval, 1.12-1.61), anemia (OR, 1.16; 95% CI, 1.02-1.32), fibromyalgia (OR, 1.19; 95% CI, 1.03-1.38), traumatic brain injury (OR, 1.58; 95% CI, 1.21-2.07), and Medicaid eligibility (OR, 1.48; 95% CI, 1.24-1.75) were all independently associated with lower CPAP adherence. Medicaid eligibility was considered an indicator of lower socioeconomic status.

Study Results Released on Screening for Newborns


Masimo announced the results of a prospective study published in the International Journal of Neonatal Screening in which researchers in Marrakesh, Morocco, conducted the first Moroccan study on critical congenital heart disease (CCHD) screening for newborns using Masimo SET pulse oximetry. The authors concluded that “Our results encourage us to strengthen screening for CCHD by adding pulse oximetry to the routine newborn screening panel.” Slitine and colleagues sought to improve early detection of CCHD in Morocco by studying the feasibility of implementing CCHD screening using pulse oximetry. From March 2019 to January 2020, 8,013 asymptomatic newborns at Mother and Child Hospital (part of the Mohammed VI University Hospital of Marrakesh), who were “normal” according to neonatal examination using the current standard, were screened for CCHD in accordance with American Academy of Pediatrics (AAP) guidelines, including pre- and post-ductal oxygen saturation measurement, using Masimo Rad-97 and Radical-7 Pulse CO-Oximeters with Masimo SET pulse oximetry sensors. The researchers found that, of the 8,013 infants screened, 7,998 newborns had a negative screen (99.82%) and 15 newborns were screen positive (0.18%). Of those 15, five were later diagnosed with CCHD and five with non-critical CHD; five were false positives (three of which had other underlying conditions). Of the 7,998 infants who passed, there was one false negative, an infant who was later diagnosed, at 2 months of age, with coarctation of the aorta. The researchers noted that the screening test was “easy, simple, reliable, reproducible, acceptable, discriminating, well-accepted by parents and caregivers, and did not involve parental anxiety.” They also noted that “Pulse oximetry has a good specificity and sensitivity and thereby fulfills the criteria for screening. Additionally, most of the data in the literature suggest a favorable cost-effectiveness of this technique.” The authors concluded, “Screening for CCHD is a reliable method for the early detection of critical congenital heart disease and even non-cardiac conditions. We think that it will have positive repercussions on infant mortality and morbidity in Morocco. It is an optimal test and it adapts perfectly to our context. We hope to implement it locally and nationally, as consistent with international best practice for newborn screening, to allow for timely detection of the infants born with CCHD in Morocco.”Although the researchers at times use the term pulse oximetry generally, the specific pulse oximetry technology used in this study, as noted, was Masimo SET. To date, six other large published CCHD screening studies, as well as additional, smaller studies, have used Masimo SET. Cumulatively, the large studies represent 284,800 infants, which includes the largest CCHD study to date, of 122,738 newborns. All of these CCHD studies with Masimo SET pulse oximetry showed improved screening sensitivity with the use of Masimo SET alongside clinical assessment when compared to routine physical exam alone. With its ability to accurately measure through motion and low perfusion, alongside its performance in outcome studies, Masimo SET stands out as the established choice of pulse oximetry technology for clinicians and policy makers hoping to implement CCHD screening processes.

Asthma Leads Spending on Avoidable Pediatric Inpatient Stays


Hospital charges for the treatment of children with asthma made up nearly half of all potentially avoidable pediatric inpatient costs in 2017, according to the Agency for Healthcare Research and Quality. The cost of potentially avoidable visits for asthma that year was $278 million, versus $284 million combined for the other three conditions "that evidence suggests may be avoidable, in part, through timely and quality primary and preventive care," Kimberly W. McDermott, PhD, and H. Joanna Jiang, PhD, said in an AHRQ statistical brief. Those three other conditions are diabetes short-term complications, gastroenteritis, and urinary tract infections (UTIs). Neonatal stays were excluded from the analysis. The state inpatient databases of the AHRQ's Healthcare Cost and Utilization Project included 1.4 million inpatient stays among children aged 3 months to 17 years in 2017, of which 8% (108,300) were deemed potentially preventable. Hospital charges for the preventable stays came to $561.6 million, or 3% of the $20 billion in total costs for all nonneonatal stays, they said. Rates of potentially avoidable stays for asthma (159 per 100,000 population), gastroenteritis (90 per 100,000), and UTIs (41 per 100,000) were highest for children aged 0-4 years and generally decreased with age, but diabetes stays increased with age, rising from 12 per 100,000 in children aged 5-9 years to 38 per 100,000 for those 15-17 years old, the researchers said. Black children had a much higher rate of potentially avoidable stays for asthma (218 per 100,000) than did Hispanic children (74), Asian/Pacific Islander children (46), or white children (43), but children classified as other race/ethnicity were higher still: 380 per 100,000. Rates for children classified as other race/ethnicity were highest for the other three conditions as well, they reported. Comparisons by sex for the four conditions ended up in a 2-2 tie: Girls had higher rates for diabetes (28 vs. 23) and UTIs (35 vs. 8), and boys had higher rates for asthma (96 vs. 67) and gastroenteritis (38 vs. 35).

Nocturnal Oxygen Therapy Reduces Hypoxemia, Apnea in COPD Patients at Altitude


COPD patients who traveled to high altitudes from low-altitude homes experienced reduced hypoxemia and sleep apnea when they were treated with nocturnal oxygen therapy, a randomized, placebo-controlled crossover trial found. The trial included 32 patients with COPD living below 800 meters with forced expiratory volume (FEV) between 30% and 80% and pulse oximetry of at least 92% who were not on oxygen therapy and had no history of sleep apnea. Researchers evaluated patients at baseline when they were at 490 meters (1,608 feet) altitude, and then during two separate stays of two days and two nights at a hotel at 2,048 meters (6,719 feet) while participants received either nocturnal oxygen therapy or a placebo treatment. Between stays in the hotel, patients spent at least two weeks back below 800 meters. Over the two nights in the hotel, patients received either nocturnal oxygen therapy or room air (placebo) administered at 3 L/min by nasal canula. At 490 meters, mean nocturnal oxygen saturation (SpO2) as measured by pulse oximetry was 92% and mean apnea-hypopnea index (AHI) measured by polysomnography was 21.6 events per hour.

When patients went to 2,048 meters and received placebo treatment, mean SpO2 was 86% and mean AHI was 34.9/h. Nocturnal oxygen therapy increased SpO2 by a mean of 9 percentage points and decreased AHI by 19.7/h. "These findings are novel and clinically important as they may alter clinical practice of counselling and treating patients with COPD travelling to high altitude," said senior study author Michael Furian of the Sleep Disorders Center and the Department of Respiratory Medicine at University Hospital Zurich in Switzerland. "Nocturnal administration of supplemental oxygen may improve oxygenation, sleep-related breathing disturbances and prevent other adverse health effects," Furian said by email. When patients were at high altitude in the study, they got a mean of 400 minutes of sleep with nocturnal oxygen therapy, compared to 349 minutes with placebo. Compared to sleep at low altitude, placebo at high altitude was associated a decrease of rapid-eye movement sleep (mean 15.4% v 11.9%); sleep efficiency (mean 81% of time in bed v 72%); and arousal index (mean 13.7/h v 18.7/h). With nocturnal oxygen therapy at high altitude, mean rapid-eye movement sleep was 15.1%; mean sleep efficiency was 78% of time in bed; and mean arousal index was 13.8/h. Beyond its small size, another limitation of the study is that the participants all had moderate to severe COPD, and the results might not be generalizable to patients with mild or very severe COPD or to individuals who spent longer than two nights at high altitude, the study team notes in JAMA Network Open. Even so, the results suggest that doctors should consider increased use of hypoxia simulation testing and the potential need to prescribe oxygen for high altitude travel to more COPD patients than they currently do, said Dr Daniel Combs, co-author of an editorial accompanying the study and an assistant professor of pediatrics and medicine at the University of Arizona in Tucson.

Versatile designs, intuitive interfaces and precision systems provide patients with therapies


Global medical technology leader Hillrom announced the launch of two new respiratory therapy devices: the Volara System, which provides hospital-grade oscillation and lung expansion (OLE) therapy, and the Synclara Cough System. "As part of our vision of Advancing Connected Care, we want to make it easy for patients to leave the hospital with the technologies they need to get better faster," said John Groetelaars, president and CEO of Hillrom. "Our new Volara System is proven to reduce hospital length of stay and time on a ventilator by delivering effective OLE therapy, and the Synclara Cough System, which delivers mechanical insufflation and exsufflation, helps keep upper airways clear. We're delighted to introduce these practical, accessible innovations to patients and their caregivers."

The Volara System delivers trusted OLE therapy, combining Continuous Positive Expiratory Pressure (CPEP), Continuous High-Frequency Oscillation (CHFO) and a nebulizer in one portable, lightweight device. Respiratory therapies delivered by the Volara System are suitable for a number of acute and chronic conditions, including post-operative pulmonary complications, that are treated both in acute care settings and at home. OLE therapy has been proven to deliver clinical and economic outcomes in acute care settings. Recently published research in the Journal of American College of Surgeons involving a 419-patient, two-phase multicenter study, showed that pulmonary treatment with OLE therapy, along with standard respiratory therapy, reduced the rate of certain post-procedural complications in high-risk surgical patients who underwent thoracic, upper abdominal or aortic open surgical procedures. The impact of OLE therapy on Postoperative Pulmonary Complications (PPC) is clinically proven, with an overall significant relative reduction in PPC by 31% and a significant relative reduction in PPC among intubated patients of 47%. The study also demonstrated a significant reduction in mean length of hospital stay to 1.6 days, a clinically relevant reduction in ICU stays to two days, and a significant reduction of 64.4 hours for time-on-ventilator. The Volara System is versatile, enabling patients to continue receiving OLE treatments with the precise settings they used in the hospital, at home. Volara can be used with a mouthpiece, face mask, tracheostomy or in-line on a ventilator. The Synclara Cough System is a non-invasive therapy that simulates a cough to remove secretions in patients with compromised peak cough flow. The Synclara Cough System uses mechanical insufflation-exsufflation technology to clear secretions from the upper airways, representing the most complete solution available to assist patients with vital secretion evacuation. Synclara has been designed with the programmability and sensing technology to deliver a more individualized treatment, the portability and ease-of-use to improve the patient experience, and specialized patient training, therapy optimization and support. "For patients with compromised lung function, cough simulation can be a lifesaving therapy," said Groetelaars. "With Synclara, we've developed a cough system that senses how a patient is breathing and automatically adjusts the cough cycle to match the patient's breathing rhythm, making it possible for caregivers to tailor therapies for specific patient needs." The Volara System and Synclara Cough System are available in the United States.

Ventilator Receives Clearance


Getinge has received 510(k) clearance from the US Food & Drug Administration (FDA) for the company’s Servo-air mechanical ventilator, which is part of the Servo family that supports intensive care ventilation ever since the first model was introduced in 1971. "We are happy to be able to help clinicians in their endeavor to save lives by adding an additional ventilator to our product offering in the US market,” says Elin Frostehav, Vice President Critical Care at Getinge. “This is also an important step for our ventilation business in other parts of the world where 510(k) approval is a prerequisite for governmental tenders.” Servo-air is a critical care ventilator. Intended for pediatric and adult patients, it includes both Invasive and Non Invasive (NIV) ventilation modes. Servo-air also features options for High Flow therapy and Servo Compass, which allows lung protective ventilation and makes it easier to follow the ARDSnet protocol. “The turbine driven Servo-air is independent from wall gas. This, in combination with its high battery capacity, makes it suitable for use in intensive care units as well as for intermediate care and intra-hospital transportation,” says Malin Graufelds, Global Product Manager Servo-air. She adds: “Servo-air has the same proven easy to use user interface with context based guidance as our high-end ventilator Servo-u, which facilitates both learning and managing a mixed fleet of Servo ventilators.” Mechanical ventilation is a key component in the ongoing fight against the new coronavirus COVID-19. Although the majority of people with COVID-19 experience an uncomplicated or mild illness, some will develop critical illness and require mechanical ventilation. “For patients with severe impairment of oxygenation, such as ARDS, it is important to use a ventilation strategy with the potential to improve patient outcomes and optimize the benefit-to-cost ratio for the lungs, heart and the respiratory muscles,” Elin Frostehav concludes.

CSL Behring Begins Trial to Evaluate Monoclonal Antibody (CSL312) for Respiratory Distress


Global biotherapeutics leader CSL Behring today announced that the first patient has been enrolled in its Phase 2 study to assess the safety and efficacy of CSL312 (garadacimab, Factor XIIa antagonist monoclonal antibody) to treat patients suffering from severe respiratory distress, a leading cause of death in patients with COVID-19 related pneumonia. In this multicenter, double-blind, placebo-controlled study, approximately 124 adult patients testing positive for the SARS CoV-2 infection will be randomized to receive either CSL312 or placebo, in addition to standard of care (SOC) treatment. The primary endpoint being the incidence of tracheal intubation or death. “The greatest clinical challenge in treating patients with severe COVID-19 and improving outcomes has been our ability to manage the serious respiratory complications associated with the disease,” said Lars Groenke, R&D Lead, Respiratory Therapeutic Area, CSL Behring. “Our hope with CSL312 is to be able to prevent the progression of COVID-19, improve patient outcomes, and provide physicians with an effective tool in the fight against this deadly virus.” Currently, CSL Behring is evaluating five approaches across its plasma fractionation and recombinant and antibody strategic scientific platforms to preventing and treating COVID-19. In addition to the study of CSL312, CSL Behring: Has entered into a partnering agreement with the Coalition for Epidemic Preparedness Innovations (CEPI), and The University of Queensland (UQ) to accelerate the development, manufacture and distribution of a COVID-19 vaccine candidate that has been pioneered by researchers at UQ; Is one of the founding members of the CoVIg-19 Plasma Alliance, an unprecedented industry partnership to develop CoVIg-19, a potential plasma-derived therapy for treating COVID-19. The CoVIg-19 Plasma Alliance will work toward developing the unbranded anti-SARS-CoV-2 polyclonal hyperimmune immunoglobulin medicine with the potential to treat individuals with serious complications from COVID-19, and to support national governments in their efforts to fight the current pandemic. The collaboration will leverage leading-edge expertise and work that the companies already have underway; Is developing an anti-SARS-CoV-2 plasma product for the Australian market with the potential to treat people with serious complications of COVID-19, particularly those whose illness is progressing towards the need for ventilation. The investigational product, to be known as COVID-19 Immunoglobulin, is under development at the company’s advanced manufacturing facility located in Broadmeadows, Victoria; Has also formed a partnership with SAB Biotherapeutics, a clinical-stage biopharmaceutical company, to advance and deliver a novel immunotherapy targeting COVID-19. The potential therapy would be produced without the need for blood plasma donations from recovered COVID-19 patients. Clinical trials could begin this summer in North America. “When it comes to COVID-19, we have gone all in on the battle and are in the fight together with many external partners,” said Bill Mezzanotte, MD, MPH, Executive Vice President, Head of Research and Development, and Chief Medical Officer for CSL Behring. “Whether it is preventative with vaccines, or preventing progression with a hyperimmune, or using our monoclonal antibodies, like CSL312, to help people who are experiencing severe respiratory complications, CSL has taken on projects we think make sense both scientifically and that fit our capabilities. In this way we are most likely to deliver on our promise to patients by helping find solutions to stop this virus and to treat the damage it inflicts on people.”

Study Confirms Accuracy


Masimo announced the results of a study published in Pneumonia in which independent researchers in New Delhi, India, investigated the accuracy of Masimo RRp on pediatric patients with the Rad-G™ Pulse Oximeter by comparing it to clinician-determined values while performing routine assessment of children admitted to outpatient and emergency departments. RRp provides respiration rate determined from the photoplethysmograph used in pulse oximetry. Noting the high incidence of childhood pneumonia in many parts of the world, the inclusion of oxygen saturation (SpO2) and respiratory rate measurement in pneumonia screening guidelines, and the scarcity of medical equipment and variability in medical training in many low-resource settings, Dr Alwadhi and colleagues sought to determine whether a “multi-modal” pulse oximeter, Masimo Rad-G, could also accurately measure respiration rate—supporting future applications for a more streamlined and reliable approach to pneumonia screening case management. Rad-G uses a single Masimo SET pulse oximetry sensor to measure both SpO2 and RRp, as well as pulse rate (PR), perfusion index (Pi), and pleth variability index (PVi). In this particular study, the researchers used Rad-G, alongside traditional pediatrician assessment, to measure the respiration rate of 97 children (aged 2 to 59 months) admitted to the outpatient and emergency departments at Kalawati Saran Hospital in New Delhi, over 2 weeks. They then analyzed the level of agreement between plethysmography-based respiration rate (RRp) and the clinicians’ assessment of respiration rate. The researchers found that RRp and the control respiration rate measurement method showed “significant strong association (97%)” (p < 0.001), and that “values obtained either from pulse oximeter or by pediatrician (gold standard) are very close to each other.” For assessing fast breathing (defined as ≥ 50 breaths per minute (bpm) for infants 2 to 12 months and ≥ 40 bpm for children older than 12 months), RRp had high sensitivity (95%) and specificity (94%), with 95% accuracy. Based on these findings, the authors explained, “The sensitivity analysis, in addition, points to the reliability of the device in correctly identifying fast breathing, a major symptom of the disease [pneumonia], in 95% of the cases.” They also noted that Rad-G “allows for significantly integrated results of RR and SpO2 with high sensitivity and accuracy in health care settings, as well as the possibility of rapid detection.” The researchers concluded, “There is a high degree of agreement between pleth-based RR using a [pulse oximetry device] and physician measured RR, indicating that the former provides reliable and accurate measurement. Current diagnosis and management of pneumonia in primary health care is based on variably trained health providers despite IMCI [Integrated Management for Childhood Illness] guidelines. The use of pulse oximeters, also recommended by the WHO, which can provide reliable measurement, would streamline pneumonia case management in these settings. The current study provides evidence of the reliability of pulse oximeter[s].”

Asthma Patients: Stay on Steroids in Face of COVID-19, Say Experts


With COVID-19 infections documented in every US state and clinicians waking up to the fact that this is everywhere, there is still lack of clarity on many basic points about the management of infection. Although most people can be expected to recover at home without complications, patients with asthma are among those at risk for serious illness, according to the Centers for Disease Control and Prevention (CDC). And people with asthma "have concerns about the steroids in their asthma inhalers weakening their immune system," notes the Asthma and Allergy Foundation of America (AAFA) website. But asthma specialists are stressing that patients must keep using their preventive inhalers during this pandemic. "People with asthma need their [preventive] steroids," said Mitchell Grayson, MD, an allergist–immunologist at Nationwide Children's Hospital and chair of the medical scientific council for the AAFA. Michael Blaiss, MD, executive medical director of the American College of Allergy, Asthma & Immunology (ACAAI), echoed that advice. "If a patient has asthma they need to stay on their preventive asthma medication, which in most cases would include inhaled corticosteroids," Blaiss, who is also clinical professor of pediatrics at the Medical College of Georgia in Augusta, said. Optimally controlled asthma is the first weapon in the fight against the infection, other experts concurred. "The last thing we want is patients stopping their asthma medicine and getting acutely ill," David Hill, MD, a pulmonary and critical care specialist in Waterbury, Connecticut, said. "We don't want people coming to the hospital because they stopped adhering to their therapy out of fear that the therapy was going to cause a problem." "If you have asthma and you are sick and you're bronchospastic and wheezing that's a reason to use steroids," stressed Hill, who is a spokesperson for the American Lung Association. Part of the confusion is arising from reports of concerns about corticosteroid treatment in patients in general with lung involvement because of COVID-19 infection. Advice for those in the general population infected with COVID-19 is that "corticosteroids are to be avoided" during treatment, according to the CDC as well as the World Health Organization. This current consensus that there is no reason "to expect that patients [in general] with COVID-19 infection will benefit from corticosteroids, and they might be more likely to be harmed with such treatment," is also detailed in a Lancet commentary published last month.

Expression of SARS-CoV-2 Receptor ACE2 Higher in Type-2-Low Asthma Patients


Type-2-low asthmatics have higher expression of the SARS-CoV-2 receptor ACE2 in bronchial epithelium, as well as characteristics associated with increased risk of severe COVID-19, according to new findings. The findings suggest that these patients may be at especially high risk of contracting COVID-19, and developing severe disease if they do become infected, Dr Sally Wenzel, director of the Asthma and Environmental Lung Health Institute at the University of Pittsburgh Medical Center (UPMC), said. "They should not be putting themselves into high-risk situations, they should be continuing to work at home as much as they can," Wenzel said. "We would certainly want them to have their asthma under the best possible control." The question of whether asthma increases the risk of severe COVID-19, or might even be protective, is controversial, she noted. "One of the reasons for that uncertainty is that asthma is a very heterogenous disease, and there are very likely to be subgroups of people with asthma that are high risk." Wenzel and her team studied two large cohorts of asthma patients with stable disease to investigate whether ACE2 expression was associated with immune polarization. Low absolute blood eosinophil count, a marker of Type 2 inflammation, was associated with increased ACE2 expression in bronchial epithelial cells (BEC), they found. ACE2 expression also correlated with expression of genes upregulated in viral infections, the team reports in the Journal of Allergy and Clinical Immunology. When patients were clustered into four groups based on BEC gene expression, the authors found that levels of blood eosinophils varied with ACE2 expression. Patient cluster 1 (PC1), which had the highest mean Type-1-gene expression score, also had the highest level of ACE2 transcripts and the lowest mean Type-2-gene expression. PC1 was all male, with higher mean resting diastolic pressure and a trend toward a greater likelihood of having been diagnosed with hypertension. Patients in this group also had a higher neutrophil-to-lymphocyte ratio and lower absolute levels of lymphocytes and eosinophils, characteristics also associated with COVID-19. They also had elevated lymphocytes in bronchoalveolar lavage (BAL). "One of the surprising things from the findings was that we were able to so clearly link what was going on with the epithelial lining in the lung with the signature in the peripheral blood," Dr Matthew J. Camiolo, a clinical instructor at UPMC and the study's lead author, said. "It may give us some insight into things we can test for in the blood." He added: "This is very much a pilot study, and there will have to be confirmatory work to give us a sense of what's going on at the protein level."

Asthma Leads Spending on Avoidable Pediatric Inpatient Stays


Hospital charges for the treatment of children with asthma made up nearly half of all potentially avoidable pediatric inpatient costs in 2017, according to the Agency for Healthcare Research and Quality. The cost of potentially avoidable visits for asthma that year was $278 million, versus $284 million combined for the other three conditions "that evidence suggests may be avoidable, in part, through timely and quality primary and preventive care," Kimberly W. McDermott, PhD, and H. Joanna Jiang, PhD, said in an AHRQ statistical brief. Those three other conditions are diabetes short-term complications, gastroenteritis, and urinary tract infections (UTIs). Neonatal stays were excluded from the analysis, McDermott of IBM Watson Health and Jiang of the AHRQ noted. The state inpatient databases of the AHRQ's Healthcare Cost and Utilization Project included 1.4 million inpatient stays among children aged 3 months to 17 years in 2017, of which 8% (108,300) were deemed potentially preventable. Hospital charges for the preventable stays came to $561.6 million, or 3% of the $20 billion in total costs for all non-neonatal stays, they said. Rates of potentially avoidable stays for asthma (159 per 100,000 population), gastroenteritis (90 per 100,000), and UTIs (41 per 100,000) were highest for children aged 0-4 years and generally decreased with age, but diabetes stays increased with age, rising from 12 per 100,000 in children aged 5-9 years to 38 per 100,000 for those 15-17 years old, the researchers said. Black children had a much higher rate of potentially avoidable stays for asthma (218 per 100,000) than did Hispanic children (74), Asian/Pacific Islander children (46), or white children (43), but children classified as other race/ethnicity were higher still: 380 per 100,000. Rates for children classified as other race/ethnicity were highest for the other three conditions as well, they reported.

Many Studies of COVID-19 Antibody Test Accuracy Fall Short: Review


Many studies assessing the accuracy of COVID-19 antibody tests had major shortcomings, a review released on Thursday concluded, offering further evidence the blood tests are of little use for people seeking to know with certainty if they have been infected. Cochrane, a British-based journal that reviews research evidence to help decision makers adopt better health policies, looked at 54 studies, mostly from Asia, that sought to measure the reliability of tests purporting to show whether somebody has developed antibodies against the new coronavirus. The studies were often small, did not use the most reliable methods, and results were often incomplete, Cochrane said in its 310-page report. Also, most of those tested had been admitted to hospital, offering no insight into how well the tests could detect antibodies in the majority of people with milder symptoms. There is intense interest in these antibody tests, which rely on either a finger prick or a venous blood draw, by people eager to know whether they have had COVID-19 or not. There has been speculation that a positive result might mean people have some protection, at least temporarily, against re-infection. Such hopes are unrealistic, said Jon Deeks, a professor of biostatistics at the University of Birmingham who leads Cochrane's test evaluation efforts. "A lot of people in the UK are very interested and keen to know, but there is no decision they should be making at the moment based on the results of that test," Deeks said. In all, the Cochrane researchers identified data from 25 commercial COVID-19 tests, a fraction of roughly 300 such tests that exist. Their review did not include tests offered by Roche or Abbott Laboratories, which were approved by regulators after the cut-off deadline of April 27. Updates of Cochrane's report plan to include data from both companies' tests, which are now being sold by the millions in the United States and Europe. While the studies reviewed by Cochrane showed the antibody tests were better at detecting COVID-19 antibodies in people two or more weeks after their symptoms started, they did not provide clues as to how well they work in patients further from infection. Such gaps undermine the value of tests as tools in so-called "seroprevalence studies", to determine what percentage of people in a population may have been exposed to the virus. "We don't know how well these tests work beyond five weeks, so that's our greatest concern," Deeks said. "In seroprevalence studies, you're looking beyond that and really we need some data which says, 'How well do they work at three months, four months, five months.'"

Nocturnal Oxygen Therapy Reduces Hypoxemia, Apnea in COPD Patients at Altitude


COPD patients who traveled to high altitudes from low-altitude homes experienced reduced hypoxemia and sleep apnea when they were treated with nocturnal oxygen therapy, a randomized, placebo-controlled crossover trial found. The trial included 32 patients with COPD living below 800 meters with forced expiratory volume (FEV) between 30% and 80% and pulse oximetry of at least 92% who were not on oxygen therapy and had no history of sleep apnea. Researchers evaluated patients at baseline when they were at 490 meters (1,608 feet) altitude, and then during two separate stays of two days and two nights at a hotel at 2,048 meters (6,719 feet) while participants received either nocturnal oxygen therapy or a placebo treatment. Between stays in the hotel, patients spent at least two weeks back below 800 meters. Over the two nights in the hotel, patients received either nocturnal oxygen therapy or room air (placebo) administered at 3 L/min by nasal canula. At 490 meters, mean nocturnal oxygen saturation (SpO2) as measured by pulse oximetry was 92% and mean apnea-hypopnea index (AHI) measured by polysomnography was 21.6 events per hour. When patients went to 2,048 meters and received placebo treatment, mean SpO2 was 86% and mean AHI was 34.9/h. Nocturnal oxygen therapy increased SpO2 by a mean of 9 percentage points and decreased AHI by 19.7/h. "These findings are novel and clinically important as they may alter clinical practice of counselling and treating patients with COPD travelling to high altitude," said senior study author Michael Furian of the Sleep Disorders Center and the Department of Respiratory Medicine at University Hospital Zurich in Switzerland. "Nocturnal administration of supplemental oxygen may improve oxygenation, sleep-related breathing disturbances and prevent other adverse health effects," Furian said by email. When patients were at high altitude in the study, they got a mean of 400 minutes of sleep with nocturnal oxygen therapy, compared to 349 minutes with placebo. Compared to sleep at low altitude, placebo at high altitude was associated a decrease of rapid-eye movement sleep (mean 15.4% v 11.9%); sleep efficiency (mean 81% of time in bed v 72%); and arousal index (mean 13.7/h v 18.7/h). With nocturnal oxygen therapy at high altitude, mean rapid-eye movement sleep was 15.1%; mean sleep efficiency was 78% of time in bed; and mean arousal index was 13.8/h. Beyond its small size, another limitation of the study is that the participants all had moderate to severe COPD, and the results might not be generalizable to patients with mild or very severe COPD or to individuals who spent longer than two nights at high altitude, the study team notes in JAMA Network Open. Even so, the results suggest that doctors should consider increased use of hypoxia simulation testing and the potential need to prescribe oxygen for high altitude travel to more COPD patients than they currently do, said Dr Daniel Combs, co-author of an editorial accompanying the study and an assistant professor of pediatrics and medicine at the University of Arizona in Tucson.

The evidence for HeRO continues to build


Two more publications about HeRO are now available. Please check the company’s publications page on its website regularly for the details and links to all the papers. If you have ideas for new research topics or if you are interested in deploying HeRO in your unit, then reach out. Following their earlier work on the use of HeRO with respect to intubation and extubation, Chakraborty et. al, have published Predicting Extubation Outcomes Using Heart Rate Characteristics Index in Preterm Infants: A Cohort Study. They present predictive models that assess readiness for extubation using physiological data and HeRO. These models are freely available, hosted by MPSC.

Masimo Announces FDA Clearance of Centroid


Masimo announced that Centroid, a wearable, wireless patient orientation, activity, and respiration rate sensor, has received FDA clearance. Centroid helps clinicians monitor patient position to avoid preventable pressure ulcers, and can alert clinicians to sudden movements such as fall-like events. In addition, Centroid detects chest movements to continuously provide respiration rate, assisting clinicians with additional data that may inform care decisions. Centroid pairs with the Root Patient Monitoring and Connectivity Platform using Bluetooth to track a patient’s posture, orientation, and activity, providing the ability to monitor patient position and detect changes in position. The data transmitted by Centroid can be displayed in various formats on Root, giving clinicians multiple ways to assess adherence to protocols regarding tissue stress and to tailor care to the specific needs of each patient. Pressure sores affect nearly 2.5 million patients per year in U.S. hospitals alone, and approximately 60,000 of those patients die as a direct result.1 Centroid is indicated for the orientation monitoring of patients who may be susceptible to pressure ulcers, by tracking patient movement and activity using an accelerometer and gyroscope. Centroid can identify a patient’s position and orientation to the nearest degree, with alerts based on the duration in a static position to help clinicians adhere to hospital patient turn protocols. Centroid also features customizable alarm zones to help avoid patient positions that could negatively impact recovery time. Unlike simple time-based rotation protocols, Centroid uses the cumulative time spent in each position, as well as existing sore data, to calculate relative risk, displayed on the Root screen using color-coded markers, helping clinicians identify the potential severity of tissue stress for each position—and ultimately, helping to guide clinical decisions about the most appropriate, least risky positions for each patient. In addition, because Centroid can identify whether a patient is lying down, standing, sitting upright, walking, or may have fallen, it can notify clinicians of a sudden change in position that might provide early warning of a potential fall, by alerting them when clinician-defined movement thresholds are crossed. Its respiration rate performance, validated against manually scored capnogram respiratory measurements, is accurate to within 3 respirations per minute (rpm) in the range of 8 to 35 rpm. The Centroid single-patient-use sensor is ergonomically designed for application on the chest using flexible, lightweight material for patient comfort, with a gentle adhesive that supports continuous use during daily activities. Each battery-operated sensor is designed to last four days, minimizing the need for frequent replacement. Joe Kiani, Founder and CEO of Masimo, said, “We are committed to using our expertise in signal processing and sensor design to develop new ways to provide the highest quality, most relevant data to clinicians in the most intuitive, useful formats, and Centroid, coupled with Root’s rich high-resolution display, is a great example of this. We hope that by helping to automate the process of tracking and making decisions about patient position, we can help clinicians reduce the frequency and severity of pressure ulcers, and ultimately improve patient outcomes.”

Trial Shows Big Results


Full results from the positive Phase III ETHOS trial showed AstraZeneca’s triple-combination therapy PT010 (budesonide/glycopyrronium/formoterol fumarate) demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations compared with two dual-combination therapies in patients with moderate to very severe chronic obstructive pulmonary disease (COPD). Compared with glycopyrronium/formoterol fumarate, PT010 achieved a 24% reduction (p<0.001) in exacerbations. PT010 achieved a 13% reduction (p=0.003) compared with PT009 (budesonide/formoterol fumarate). The dual-combination therapies used as comparators in the trial represent recommended therapeutic classes for the treatment of COPD. In a key secondary endpoint, PT010 showed a 46% reduction in the risk of all-cause mortality compared with glycopyrronium/formoterol fumarate (unadjusted p=0.01). The results were published in the New England Journal of Medicine and simultaneously presented at the American Thoracic Society virtual Scientific Symposium, Clinical Trial Results in Pulmonary Medicine. AstraZeneca will continue to review these data with health authorities. Klaus Rabe, Professor of Pulmonary Medicine at the University of Kiel, Director of the Department of Pneumology at Clinic Grosshansdorf, Germany, and Lead Investigator of the ETHOS trial, said: “The Phase III ETHOS trial results are important and demonstrate the benefit of PT010 in reducing the rate of exacerbations in this progressive disease. The findings also show that reducing risk of all-cause mortality is achievable and could transform treatment goals in chronic obstructive pulmonary disease.” Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “Chronic obstructive pulmonary disease is the third leading cause of death worldwide and exacerbations can contribute to an increase in mortality in these patients. The results of the Phase III ETHOS trial support the strong clinical profile of PT010 in reducing exacerbation rates compared with dual-combination therapies. We are excited to have the data on all-cause mortality, which is a key consideration for COPD management.” The safety and tolerability of PT010 were consistent with the known profiles of the dual comparators. In the trial, the most frequently reported adverse events were nasopharyngitis, COPD and upper respiratory tract infection. The incidence of confirmed pneumonia was 4.2% with PT010, 2.3% with glycopyrronium/formoterol fumarate and 4.5% with PT009. These results are based on PT010 at the standard dose of budesonide (budesonide/glycopyrronium/formoterol fumarate 320/14.4/9.6mcg), an inhaled corticosteroid (ICS). In the trial, PT010 at half the dose of budesonide (budesonide/glycopyrronium/formoterol fumarate 160/14.4/9.6mcg) also demonstrated a statistically significant reduction in the rate of moderate or severe exacerbations compared with glycopyrronium/formoterol fumarate (14.4/9.6mcg) and PT009 (budesonide/formoterol fumarate 320/9.6mcg). PT010 is approved in Japan and China for patients with COPD. It is also under regulatory review in the US and EU.

New Way to Monitor Sleep


Masimo announced a new health and wellness home monitoring solution, Masimo Sleep, designed to help consumers better understand the quality of their sleep. Masimo Sleep is fueled by the same expertise in signal processing and sensor development that drives the Masimo hospital products used by leading institutions to monitor over 200 million patients a year. Masimo Sleep is available for pre-order starting today at Masimo Sleep, a wearable sleep quality solution based on clinically proven vital signs technology, is unlike any other sleep management solution available to consumers. Masimo Sleep analyzes your data to provide truly personalized multi-dimensional insight into your sleep health—empowering you with actionable guidance to help you make healthier lifestyle choices that improve your sleep. The user wears a lightweight sensor (for up to ten nights per sensor), while the Sleep app collects the user’s data using clinically proven Masimo SET pulse oximetry to track changes in key vital signs during sleep. By analyzing oxygenation, heart rate, and respiratory rate overnight, Masimo Sleep can provide guidance to help users better understand, for example, why they may snore or wake up tired, and recommend ways for the user to improve the quality of their sleep. Other at home products look at proxies for healthy sleep, like how often users roll over, or listen to the sound of users' breathing and snoring, rather than their vital signs. Masimo Sleep helps people to better understand their physiological status overnight—from the comfort of their own bed. Joe Kiani, Founder and CEO of Masimo, said, “We are delighted to unveil Masimo Sleep as part of our line of direct-to-consumer solutions, which also includes the MightySat fingertip pulse oximeter. Based on our expertise in monitoring the physiological status of hundreds of millions of patients each year, Masimo Sleep significantly expands consumers’ ability to make healthier decisions, at home, by equipping them with what we believe is the best solution for this need.” Masimo Sleep is not FDA 510(k) cleared. It is available as a general wellness product.

Device Helps Neonatal Oral Intubations


The SecureET Neonatal Endotracheal Tube Securement Device from Westmed ( is the latest design available for neonatal oral intubations. The SecureET Endotracheal Tube holder features hydrocolloid material for skin contact and helps prevent accidental extubation by providing a secure method of stabilization. SecureET enables fast and easy application to secure endotracheal tubes sizes 2.5, 3.0, 3.5, and 4.0 mm. Each device is color coded for the size tube. SecureET facilitates placement options for the tube location in the oral cavity and may be moved to prevent palate grooving. SecureET allows for tube depth adjustment without disturbing the skin contacting hydrocolloid base. In addition, SecureET is the only neonatal ET Tube securement device with an optional head bonnet for superior security.

Noninvasive Ventilation May Beat Standard Oxygen for AHRF, Study Shows


Helmet or face mask noninvasive ventilation (NIV) may help patients survive acute hypoxemic respiratory failure (AHRF) or avoid endotracheal intubation, a new study shows. One expert would like to see access to these technologies expanded to include outpatients as well. "There are multiple alternatives to standard oxygen which seem to be better," lead author Bruno L. Ferreyro, MD, from the University of Toronto and Sinai Health System and University Health Network, Toronto, Canada, said. "All of these interventions could be effective, but clinicians need to know that none of these interventions should delay timely intubation. Patients who need to be intubated need to be intubated.... [Delaying intubation] has been shown to be harmful for patients," he continued.

"The current coronavirus disease 2019 (COVID-19) pandemic has further highlighted the importance of understanding the best approach to providing respiratory support for patients with respiratory failure," the authors write. The researchers conducted a systematic review and network meta-analysis of 25 randomized clinical trials involving 3804 participants. The primary outcome was all-cause mortality, which was measured at the longest time point during the first 90 days after randomization.

The secondary outcome was endotracheal intubation up to 30 days. Other secondary outcomes were "patient comfort, dyspnea scores, intensive care unit and hospital lengths of stay, and 6-month mortality," the authors explain. Treatment with helmet NIV (risk ratio [RR], 0.40; absolute risk difference, –0.19; low certainty) and face mask NIV (RR, 0.83; absolute risk difference, –0.06; moderate certainty) were linked to a lower risk for mortality compared with standard oxygen therapy (21 studies; 3370 patients). High-flow nasal oxygen (RR, 0.87; absolute risk difference, –0.04; moderate certainty), however, was not linked to a significantly lower risk for death in comparison with standard oxygen. Compared with high-flow nasal oxygen (RR, 0.46; absolute risk difference, –0.15; low certainty) and face mask NIV (RR, 0.48; absolute risk difference, –0.13; low certainty), helmet NIV was associated with significantly decreased mortality. "In the case of face mask, we saw a very small marginal benefit in mortality, and that is a little bit against most recent trials, like the Frat trial," Ferreyro said. "That association did not stand in multiple scenarios, for example, in patients with more severe respiratory states." The risk for endotracheal intubation was lower among those who received helmet NIV (RR, 0.26; absolute risk difference, –0.32; low certainty), face mask NIV (RR, 0.76; absolute risk difference, –0.12; moderate certainty), and high-flow nasal oxygen (RR, 0.76; absolute risk difference, –0.11; moderate certainty) (25 studies; 3804 patients) in comparison with standard oxygen.

Chronic PTSD Linked to Altered REM Sleep Without Atonia


Patients with chronic posttraumatic stress disorder (PTSD) are at increased risk for altered REM sleep without atonia (RSWA), new research suggests. Atonia is the normal temporary paralysis of arms and legs that occurs during REM sleep; RSWA is characterized by abnormal muscle activity during sleep. A study of more than 100 civilians showed that those with chronic PTSD, either alone or with REM sleep behavior disorder (RBD), had significantly higher levels of RSWA than a group of their healthy peers. In addition, higher levels of RSWA were found in the participants with both PTSD and RBD than in those with PTSD only. "These data provide the first evidence for abnormal RSWA control in [civilian] patients with chronic PTSD," the researchers note. "This suggests a unique biology in PTSD, which may overlap with that of RBD and could imply a future risk for neurodegenerative disease in PTSD similar to RBD patients," coinvestigator John Feemster, medical student at the Medical College of Wisconsin, Wausau, and research assistant at the Mayo Clinic Center for Sleep Medicine, Rochester, Minnesota, said.

By the Numbers: Asthma-COPD Overlap Deaths


Death rates for combined asthma and chronic obstructive pulmonary disease declined during 1999-2016, but the risk remains higher among women, compared with men, and in certain occupations, according to a recent report from the Centers for Disease Control and Prevention. There is also an association between mortality and nonworking status among adults aged 25-64 years, which "suggests that asthma-COPD overlap might be associated with substantial morbidity," Katelynn E. Dodd, MPH, and associates at the CDC's National Institute for Occupational Safety and Health said in the Morbidity and Mortality Weekly Report. "These patients have been reported to have worse health outcomes than do those with asthma or COPD alone." For females with asthma-COPD overlap, the age-adjusted death rate among adults aged 25 years and older dropped from 7.71 per million in 1999 to 4.01 in 2016, with corresponding rates of 6.70 and 3.01 per million for males, they reported. In 1999-2016, a total of 18,766 U.S. decedents aged ≥25 years had both asthma and COPD assigned as the underlying or contributing cause of death (12,028 women and 6,738 men), for an overall death rate of 5.03 per million persons (women, 5.59; men, 4.30), data from the National Vital Statistics System show. Additional analysis, based on the calculation of proportionate mortality ratios (PMRs), also showed that mortality varied by occupational status and age for both males and females, the investigators said, noting that workplace exposures, such as dusts and second0hand smoke, are known to cause both asthma and COPD. The PMR represents the observed number of deaths from asthma-COPD overlap in a specified industry or occupation, divided by the expected number of deaths, so a value over 1.0 indicates that there were more deaths associated with the condition than expected, Ms. Dodd and her associates explained. Among female decedents, the occupation with the highest PMR that was statistically significant was bartending at 3.28. For men, the highest significant PMR, 5.64, occurred in logging workers. Those rates, however, only applied to one of the two age groups: 25-64 years in women and ≥65 in men, based on data from the National Occupational Mortality Surveillance, which included information from 26 states for the years 1999, 2003, 2004, and 2007-2014. Occupationally speaking, the one area of common ground between males and females was lack of occupation. PMRs for those aged 25-64 years "were significantly elevated among men (1.98) and women (1.79) who were unemployed, never worked, or were disabled workers," they said. PMRs were elevated for nonworking older males and females but were not significant. The elevated PMRs suggest "that asthma-COPD overlap might be associated with substantial morbidity resulting in loss of employment [because] retired and unemployed persons might have left the workforce because of severe asthma or COPD," the investigators wrote.

Oral Masitinib Improves Severe Asthma


Oral masitinib (AB Science) decreases exacerbations in patients with severe asthma uncontrolled by oral corticosteroids, irrespective of eosinophil count, new research shows. "This is one of the most unmet needs in asthma patients," said principle investigator Pascal Chanez, MD, PhD, from the University of Aix-Marseille, France. "For patients without an eosinophilic marker for consistent allergic triggers, there is a huge burden of disease," he said. "Currently, the only treatment for them is systemic corticosteroids." For severe asthma, "we think this drug offers a piece of the treatment puzzle," Chanez said, explaining that severe asthma is a costly chronic disorder that causes disability and hospitalization. What's more, he said he believes masitinib will have good patient adherence because it is an oral medication, "not an injection." Chanez had been scheduled to present findings from the study on this small-molecule biologic at the American Thoracic Society (ATS) 2020 International Conference this month; instead, a virtual ATS meeting was set to be held in August. Masitinib, an oral stem-cell-factor receptor tyrosine kinase inhibitor, targets mast cells and macrophages that are affected in asthma by inhibiting three protein kinases: c-Kit, Lyn, and Fyn.

Asthma Prolongs Intubation Time in COVID-19 Patients


Asthma may prolong the time a person hospitalized with COVID-19 is on a ventilator, a new study suggests. "Although asthmatics might not be at higher risk to acquire the virus, once they do, asthmatics have a significantly more difficult time with . . . longer intubation and ICU admission," Dr Mahboobeh Mahdavinia of Rush University Medical Center in Chicago said by email. To assess the impact of preexisting asthma on COVID-19 outcomes, the researchers studied 935 patients with confirmed COVID-19, of whom 241 (25.8%) had a diagnosis of asthma. Asthmatic patients with COVID-19 required intubation for about five days more on average than non-asthmatic patients with COVID-19 (P=0.01), the researchers report in The Journal of Allergy and Clinical Immunology: In Practice. The longer intubation time with asthma was seen in people aged 18 to 64 but not in those age 65 and older. This suggests that "younger individuals with asthma may require extra attention as they could develop a sustained pulmonary failure with COVID-19 infection, leading to a prolonged mechanical ventilation," the researchers write. The analysis was adjusted for both obesity and gender, which indicates that asthma is independently linked to intubation duration, they note. There was a trend toward longer hospital stays among patients asthma in those 50 to 64 years old but not in the younger or older age groups. Asthma was not associated with higher rate of death (1.1% vs. 3% in asthmatics vs. non-asthmatics, P=0.22) nor with acute respiratory distress syndrome (8.9% vs. 9.5%; P=0.92).

Noninvasive Ventilation May Beat Standard Oxygen for AHRF, Study Shows


Helmet or face mask noninvasive ventilation (NIV) may help patients survive acute hypoxemic respiratory failure (AHRF) or avoid endotracheal intubation, a new study shows. One expert would like to see access to these technologies expanded to include outpatients as well. "There are multiple alternatives to standard oxygen which seem to be better," lead author Bruno L. Ferreyro, MD, from the University of Toronto and Sinai Health System and University Health Network, Toronto, Canada, said. "All of these interventions could be effective, but clinicians need to know that none of these interventions should delay timely intubation. Patients who need to be intubated need to be intubated.... [Delaying intubation] has been shown to be harmful for patients," he continued. "The current coronavirus disease 2019 (COVID-19) pandemic has further highlighted the importance of understanding the best approach to providing respiratory support for patients with respiratory failure," the authors write. The researchers conducted a systematic review and network meta-analysis of 25 randomized clinical trials involving 3804 participants. The primary outcome was all-cause mortality, which was measured at the longest time point during the first 90 days after randomization. The secondary outcome was endotracheal intubation up to 30 days. Other secondary outcomes were "patient comfort, dyspnea scores, intensive care unit and hospital lengths of stay, and 6-month mortality," the authors explain. Treatment with helmet NIV (risk ratio [RR], 0.40; absolute risk difference, –0.19; low certainty) and face mask NIV (RR, 0.83; absolute risk difference, –0.06; moderate certainty) were linked to a lower risk for mortality compared with standard oxygen therapy (21 studies; 3370 patients). High-flow nasal oxygen (RR, 0.87; absolute risk difference, –0.04; moderate certainty), however, was not linked to a significantly lower risk for death in comparison with standard oxygen. Compared with high-flow nasal oxygen (RR, 0.46; absolute risk difference, –0.15; low certainty) and face mask NIV (RR, 0.48; absolute risk difference, –0.13; low certainty), helmet NIV was associated with significantly decreased mortality. "In the case of face mask, we saw a very small marginal benefit in mortality, and that is a little bit against most recent trials, like the Frat trial," Ferreyro said. "That association did not stand in multiple scenarios, for example, in patients with more severe respiratory states."

Scientists Study Sleep During COVID-19 Pandemic


An international group of neuroscientists will examine how the world is sleeping, or failing to, during the COVID-19 pandemic, which has upended work, social and family life for countless people. Sleep is known to be critical to physical and mental health - essential for tissue repair, cell regeneration, immune function, memory, and for regulating mood and emotions. With many people anecdotally reporting sleep problems due to the new coronavirus - including difficulty falling asleep, trouble staying asleep and vivid dreams - the project co-led by neuroscientists at Britain's Oxford University will investigate their impact on people's health and daily rhythms. The International COVID-19 Sleep Study (ICOSS), will combine research from Austria, Canada, China, Finland, France, Germany, Hong Kong, Japan, Norway and the United States. "Sufficient good quality sleep helps us cope, so it's worrying to see trends of poor sleep during this pandemic. We are hoping to study this... in more detail," said Colin Espie, an Oxford professor of sleep medicine. The study will look at the impact of social confinement such as lockdowns or self-isolation on sleep. It will also examine how risks of exposure to the virus and how psychological symptoms such as anxiety, depression and post-traumatic stress can affect, or be affected by, sleep. Researchers say their aim is to understand how sleep problems have emerged and to investigate how sleep during COVID-19 has interacted with lifestyle, health and wellbeing. Data collected by the research teams will feed into an international database. The findings, Espie said, should help scientists "understand the challenges, but also to figure out solutions to keep the population well-slept and healthy."

Science Does Not Link Pandemic H1N1 Flu Vaccine to Sleep Disorder


British drugmaker GSK said on Thursday that its previous flu pandemic vaccine, which used some of the same ingredients as COVID-19 vaccines currently under development, was not linked to a rise in cases of the sleep disorder narcolepsy.
A spokesman for GSK said the "science has moved on" since concerns were raised about links between narcolepsy and its H1N1 vaccine, called Pandemrix, which was developed during the flu pandemic 10 years ago. He said evidence now suggests the link is to the H1N1 flu virus itself, not the vaccine. Previous studies in several countries, including Britain, Finland, Sweden and Ireland, where GSK's Pandemrix vaccine was used in the 2009/2010 flu pandemic, had suggested its use was linked to a significant rise in cases of narcolepsy in children. Pandemrix's ingredients included a booster, or adjuvant, known as AS03, which GSK said on Thursday it planned to produce in large volume for possible use in COVID-19 vaccines currently being developed to fight the disease caused by the new coronavirus. AS03 could potentially be an ingredient in at least seven experimental COVID-19 vaccines, including one being developed by Sanofi, with whom GSK signed a collaboration deal in April. The Pandemrix H1N1 vaccine mixed portions of viral proteins with the AS03 adjuvant, designed to induce a stronger immune response. The shot was never used in the United States and was withdrawn from use in Europe when links to narcolepsy emerged. In a statement, GSK said available scientific data now suggest that "the rare occurrence of narcolepsy during the 2009/10 flu pandemic was triggered by the body confusing a protein in the wild type H1N1 flu virus with a human protein relevant in regulating the sleep cycle." It said studies also showed spikes in cases of narcolepsy in unvaccinated populations during that period.

Leader in Respiratory Solutions Acquires Manufacturer and Developer


CAIRE Inc., a leader in respiratory solutions for the global health care community, announced the acquisition of Spirosure, Inc. Spirosure is a California-based developer and manufacturer of an innovative technology for measuring Fractional Exhaled Nitric Oxide (FeNO), a key indicator of allergic inflammation in asthmatic patients. It is estimated that asthma affects more than 300 million individuals worldwide and recent Global Initiative for Asthma (GINA) guidelines recommend FeNO measurement as an assessment tool in the management of asthma patients. FeNO is directly associated with infiltration of eosinophils in the airways and is elevated in individuals with allergic asthma. FeNO can be used to diagnose asthma, to detect nonadherence to inhaled corticosteroids (ICS), to be an early sign of worsening asthmatic inflammation and to manage difficult-to-control asthma because an elevated FeNO level can be predictive of a good response to ICS. Japan-based NGK SPARK PLUG CO., LTD. acquired CAIRE in December 2018 to establish a global foothold in the respiratory therapy business and had previously invested in Spirosure as the latter company’s technology was in development. Spirosure will operate as a division of CAIRE to be known as CAIRE Diagnostics Inc., further expanding CAIRE’s portfolio into the diagnostic segment of respiratory care. “We are very pleased to have found an excellent strategic buyer in CAIRE through one of our key investors,” said Solomon Ssenyange, PhD, CEO and Chairman of Spirosure. “CAIRE shares our commitment to technological leadership and, with its large international organization, is well-positioned to realize the full potential of our proprietary technology both commercially and with regard to our development pipeline. We look forward to an exciting future as part of CAIRE.” Spirosure recently launched its first product to market, the Fenom Pro, a reliable and convenient to use device that accurately measures FeNO at parts-per-billion levels using a proprietary sensor technology. The product is intended to be used in the clinic setting and is currently available in the United States, the EU and India. “We are pleased to add Spirosure’s technology to our market-leading oxygen solution portfolio. FeNO is quickly becoming recognized by the clinical community as an important diagnostic and management tool for clinicians who treat asthma patients,” said Earl Lawson, President and CEO. “The acquisition of Spirosure further diversifies our portfolio and provides access to the 5 billion dollar respiratory diagnostic sector, a market segment where we anticipate rapid growth and adoption.”

Companies Reinforce Partnership


Masimo and Royal Philips, both global leaders in patient monitoring, announced that they have reinforced their partnership, whereby Philips will integrate additional Masimo measurement technologies into select IntelliVue MX-series multi-parameter monitors, to help clinicians assess cerebral oximetry and ventilation status. Core Masimo noninvasive measurements, such as SET Measure-through Motion and Low Perfusion pulse oximetry and advanced rainbow SET Pulse CO-Oximetry parameters like noninvasive hemoglobin (SpHb), have long been available on a wide range of Philips multi-parameter monitors. In 2016, Masimo and Philips entered into a multi-year business partnership involving both companies' innovations in patient monitoring and therapy solutions. Now, in 2020, Philips becomes one of Masimo's first industry partners to launch additional advanced Masimo measurements, NomoLine and O3, in their own patient monitors, sharing Masimo's expertise in capnography and regional cerebral oximetry with caregivers and patients around the world. NomoLine capnography and O3 regional oximetry measurements are available now on Philips MX500 and MX550 monitors in select markets throughout the world, and are also available directly from Masimo on its Root Patient Monitoring and Connectivity Platform and when connected to select Philips patient monitors via Philips' IntelliBridge module: NomoLine "no-moisture" sampling lines are designed for low-flow applications and can be used in a variety of clinical scenarios and care settings, on both intubated and non-intubated patients of all ages, in both low- and high-humidity applications. O3 regional oximetry may help clinicians monitor cerebral oxygenation in situations in which pulse oximetry alone may not be fully indicative of the oxygen in the brain.

Letter of Intent Signed


Monaghan Medical Corporation announced it has signed a letter of intent to enter into a sales agreement with Adherium Limited (ASX:ADR), a provider of digital health solutions for remote monitoring and data management. The partnership will combine Monaghan’s knowledge and expertise in improving patient outcomes through innovative respiratory solutions with Adherium’s digital platform that addresses sub-optimal inhaler medication use for patients with chronic disease. The agreement will see Monaghan launch the Hailie platform in the US, complementing a recently announced collaboration between Adherium and the disease management group HGE Health, and meshing well with Adherium’s global commercial strategy. “We are excited to bring this technology to our customers and provide them with a platform to help guide treatment decisions based on real-life data. Monaghan is dedicated to improving the lives of people with respiratory conditions, and our partnership with Adherium will allow us to advance that goal”, says Bill Seitz, Monaghan’s Vice President of Sales and Marketing. “Our strong customer relationships provide Adherium with a unique opportunity to bring the Hailie platform to targeted facilities across the US. It will complement our current product offering and provide us with the opportunity to expand into the digital space, while offering clinicians new ways to manage their patients remotely.” Adherium’s Hailie platform is a system of remote sensors for inhaled medication devices, mobile apps and a data cloud that empower both patients and healthcare teams. Patients and Physicians can receive reminders and track medication use, which trials have shown improves compliance to their treatment program, reduces asthma exacerbations and improves their quality of life. These insights are more important than ever to clinicians looking to keep their patients well and out of hospital. “This is a big first step in bringing extended offerings to our current and future customers,” commented Gerald Slemko, CEO of Trudell Medical Limited and President of Monaghan Medical Corporation. “There is a real synergy between the Hailie platform and the Monaghan portfolio, including our market-leading AeroChamber brand of Valved Holding Chamber. This as a real opportunity especially for uncontrolled, paediatric and adult patients, initially focused in asthma, where there is a high burden of disease and consumption of healthcare time and costs in secondary/tertiary care.” Monaghan’s parent company Trudell Medical Limited, is also committed to the partnership, having acquired an ownership interest representing 17% of Adherium’s shares.

Endowment Announced


As part of an ongoing commitment to the advancement of respiratory care, Dräger announced that it has granted the American Respiratory Care Foundation (ARCF) a $50,000 endowment to support the Craig D Smallwood Early Investigator Fellowship. This newly established program, which will be announced at the 2020 American Association for Respiratory Care (AARC) International Congress in Orlando, honors the late Craig D Smallwood, PhD, RRT, who died unexpected at the age of 36 in April 2020. Dr Smallwood was an innovative, collaborative and productive researcher who served as a mentor to up-and-coming researchers in the field of respiratory care. Before his untimely passing, he was working on the design and deployment of respiratory assist devices for treatment of COVID-19 patients in the developing world. The ARCF fellowship is designed to provide the chosen fellow with financial, experiential and mentoring resources; thereby continuing Dr Smallwood’s tradition of promoting the role of the respiratory therapist in supporting neonatal and pediatric research. “We are very pleased to receive such generous support from Dräger, a forward-thinking company that understands the importance of mentorship in respiratory care,” said ARCF Chairman Michael Amato. “This unique program remembers the valuable contributions of Dr Smallwood, and will help prepare the next generation of researchers. By supporting the ARCF, Dräger is investing in the future of respiratory care.” Dräger is one of several companies in the respiratory industry to establish an endowment to the ARCF for the purpose of creating research fellowships. This program recognizes the ongoing need for effective clinical research specifically to support neonatal and pediatric patients. “Technology advancement, innovation and new clinical practices require research,” said President and CEO for Dräger in North America, Lothar Thielen. “Establishing an annual award to support neonatal/pediatric research fosters an environment of collaboration and continues the scholarly work necessary to advance and improve patient outcomes.”

EU Panel Backs First Triple Combo Asthma Inhaler With Digital Sensor


The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended approval of Enerzair Breezhaler, the first triple-combination asthma therapy that includes an optional digital sensor. Enerzair Breezhaler, from Novartis, consists of a fixed-dose combination of three active substances ― the long-acting beta-agonist indacaterol acetate (IND), the muscarinic anticholinergic glycopyrronium bromide (GLY), and the corticosteroid mometasone furoate (MF) ― which are administered using the "dose-confirming" Breezhaler device. Enerzair Breezhaler is indicated as maintenance asthma therapy for adults whose asthma is not adequately controlled with a maintenance combination of a long-acting beta-2 agonist and a high dose of an inhaled corticosteroid and who have experienced one or more asthma exacerbations during the previous year. It's taken once daily. An optional electronic sensor can be attached to the base of the inhaler to collect data on the use of the inhaler by the patient. The data are sent to an app on a smartphone or other suitable device. The positive CHMP opinion is "a key milestone in our journey to reimagine asthma care by bringing innovative medicines and a digital companion to patients with uncontrolled asthma," Linda Armstrong, MD, Respiratory Development Unit head, Novartis Pharmaceuticals, said in a news release. "Once-daily IND/GLY/MF has the potential to improve asthma control for patients whose lives are still impacted by their disease, despite existing inhaled therapies. Additionally, we are pleased to bring an innovative sensor and app companion supplied with IND/GLY/MF to patients to help support enhanced adherence," she said. The safety and efficacy of Enerzair Breezhaler for adults patients with persistent asthma were evaluated in a phase 3 randomized, double-blind study involving more than 3000 patients. Results showed "clinically meaningful improvements in lung function and reduction of exacerbations," the EMA said in a statement. The main side effects included asthma exacerbation, nasopharyngitis, upper respiratory tract infection, and headache. The safety and efficacy of Enerzair Breezhaler have not been established in patients younger than 18 years.The CHMP also adopted a positive opinion for Zimbus Breezhaler (indacaterol, glycopyrronium, and mometasone furoate), which is a duplicate of Enerzair Breezhaler for the treatment of asthma. The CHMP opinion will now be sent to the European Commission, which will make the final decision on marketing in the European Union.

Study Looks at Options


Masimo announced the findings of a study published in the Journal of Anesthesiology and Reanimation Specialists’ Society in which researchers compared two methods of intraoperative fluid management during orthopedic spinal surgery, including Masimo PVi. In comparison to invasive and intermittent central venous pressure (CVP) measurement, noninvasive and continuous pleth variability index (PVi) provided “better cardiac stabilization with less fluid replacement, and more accurate results in the evaluation of intravascular volume status.” Dr Eralp Çevikkalp and colleagues at Celal Bayar University in Turkey, noting the importance of intraoperative fluid management during surgery and the drawbacks of traditional invasive, static fluid assessment methods such as CVP and mean arterial pressure (MAP), investigated whether PVi might provide an effective noninvasive and dynamic alternative. In a randomized, controlled trial of 100 adult patients undergoing elective posterior lumbar stabilization surgery, they compared fluid loading-induced changes as guided by PVi and by CVP. The patients were divided into two equally sized groups. In the PVi group, patients were continuously monitored using a Masimo Radical-7 Pulse CO-Oximeter, and a PVi threshold of > 14% was used to determine whether fluid was administered. (For patients with a PVi > 14%, a 250 mL crystalloid solution was administered every 5 minutes; for patients with a PVi < 14%, a 4 mL fluid infusion was administered.) In the control group, fluid administration was determined using CVP, other traditional parameters, and the 4-2-1 rule. In both groups, lactate, hemoglobin, and hematocrit levels were also recorded. The researchers found that the mean volume of intraoperative fluid replacement was 1914 ± 542.86 mL in the PVi group and 3522 ± 1098.1 mL in the control group (p < 0.05). They found that the mean units of intraoperative red blood cells (RBC) transfused was 0.08 ± 0.27 units in the PVi group and 0.42 ± 0.57 units in the control group (p < 0.05). Differences between the groups in postoperative RBC units transfused and intraoperative hemoglobin levels were not significant. The researchers concluded, “The present study has indicated that PVi monitoring is more valuable than CVP monitoring because it is noninvasive, provides better cardiac stabilization with less fluid replacement, and [provides] more accurate results in the evaluation of intravascular volume status. Failure to follow up the duration of surgery and postoperative complications are the most important limitations in our study.”

Observational Registry Moves to Next Phase


Mallinckrodt, a global biopharmaceutical company, announced that its observational registry comparing the safety and effectiveness of INOmax (nitric oxide) gas, for inhalation, in term and near-term neonates to that in preterm neonates with pulmonary hypertension (PH) was ended early due to achievement of the pre-specified primary outcome measure, non-inferiority (95 percent confidence interval: -0.0021, 0.1158, with a pre-defined margin of -0.1452). The decision was made following the second planned interim analysis at 75 percent enrollment. The company intends to share the results of this study in an appropriate scientific forum soon. INOmax is indicated for the treatment of term and near-term neonates with hypoxic respiratory failure associated with pulmonary hypertension. The safety and efficacy of INOmax in premature neonates has not been evaluated by the US Food and Drug Administration. Persistent pulmonary hypertension of the newborn (PPHN) is a serious and sometimes fatal cardiorespiratory complication of the transition to extra-uterine life. The registry trial was conducted to examine the utility of INOmax in pre-term neonates. Due to the seriousness of the condition, a randomized controlled trial cannot be conducted in the pre-term neonate population. "Mallinckrodt is extremely pleased to be able to end this registry based on positive findings much earlier than anticipated," said Steven Romano, MD, Executive Vice President and Chief Scientific Officer at Mallinckrodt. "The real-world data provided by this registry underscores our commitment to continue to expand upon the body of scientific knowledge on treatment of vulnerable patient populations, such as premature infants with pulmonary hypertension." The observational registry study was conducted across 31 sites and was designed to evaluate the effectiveness and safety of INOmax in 168 premature neonates vs term and near-term neonates (1:1) with PH. The interim analysis assessed 54 premature and 84 term and near-term neonates and demonstrated that the trial achieved the significance level for non-inferiority. Evaluation of significant improvement for each neonate is based on at least a 25 percent decrease in oxygenation index (OI) or surrogate OI (SOI) during the INOmax treatment period. No drug-related serious adverse events were attributed to study drug. At the time of the interim analysis, there were 17 adverse events of special interest reported in 16 subjects, most of which were in the preterm group and deemed not related or unlikely related to study drug. INOmax has been on the market in the U.S. since 2000 and is indicated to improve oxygenation and reduce the need for extracorporeal membrane oxygenation in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilatory support and other appropriate agents.

Company Expands Array of Devices


CAIRE Inc.’s strong portfolio of oxygen therapy solutions in China has expanded yet again with the recent release of the award-winning FreeStyle Comfort portable oxygen concentrator. Credited with pioneering the first portable oxygen concentrator, CAIRE engineers have designed this latest product with an innovative ergonomic, curved shell, and delivery features to ensure oxygen is provided with each breath. “CAIRE oxygen therapy brands – specifically the FreeStyle series – have long been relied upon to aid individuals suffering from Chronic Obstructive Pulmonary Disease. The FreeStyle Comfort is an innovative update to a proven brand with clinical enhancements and smart O2 delivery features that will further improve the delivery of oxygen to patients, also benefitting clinicians and caregivers who support their healthcare needs,” said Earl Lawson, President and CEO of CAIRE Inc. The release of the FreeStyle Comfort in China, available and distributed through the company’s Chengdu facility, meets a critical need of providing oxygen therapy, one of several treatment options, to those individuals suffering from COPD, or other long-term respiratory conditions. In April of 2018, ScienceDaily published an article regarding Tulane University’s study of the largest group of COPD across age groups in China. Research found that almost 100 million adults have COPD in China with many not aware they have the chronic lung disease. “The release of the FreeStyle Comfort in China marks an important step in serving this population of people who want to breathe better and enjoy the latest innovation and technologies in a lightweight package,” Lawson added. This is the third major release of the new portable oxygen concentrator since its official US debut in 2018, which drew top honors from industry peers and publications, and its European release in 2019. Weighing only 5 lbs., the FreeStyle Comfort offers on-demand oxygen flow and features a uniquely-designed ergonomic shape that rests comfortably against the curves of the body. Enhanced proprietary smart oxygen delivery features including CAIRE’s UltraSense technology, which ensures that oxygen is delivered in conjunction with the patient’s breath rate, and autoDOSE, which ensures delivery of oxygen even if no breath is detected, help ensure the clinical efficacy of the product. Portable oxygen concentrators, operational via battery or electrical power, take ambient air, filter it and then deliver up to 95 percent purified oxygen to the user. This convenience of being able to plug-in and recharge anywhere has contributed to portable oxygen concentrators increasing in popularity as compared with other oxygen modalities like cylinder tanks and liquid oxygen portables which rely on being refilled by a gas supplier. The device meets FAA guidelines for use on commercial air flights and offers wireless connectivity to CAIRE’s telehealth solution, CAIREview.

Respiratory Therapy proud to add Dr Ruben Dario Restrepo to its Editorial Advisory Board


Los Angeles, CA — Health journal Respiratory Therapy today announced the addition of Dr Ruben Dario Restrepo to its respected Editorial Advisory Board. Dr Restrepo is Coordinator of Research Division of Respiratory Care with UT Health San Antonio, Department of Respiratory Care, San Antonio, Texas. “We’re proud to add someone of Dr Restrepo’s caliber to the Editorial Advisory Board of Respiratory Therapy,” said Steve Goldstein, Publisher of Respiratory Therapy. “With the spread of COVID-19, the field of Respiratory Therapy is more important now than ever and our publication is dedicated to offering cutting-edge insight into how health-care professionals are handling this crisis. Dr Restrepo will help us achieve that mission.” Dr Restrepo is a Fellow of the American Association of Respiratory Care (FAARC) and the American College of Chest Physicians (CHEST), a Distinguished Teaching Professor and Distinguished CHEST Educator, and has been inducted into the Kenneth I Shine Academy of Health Science Education, and received the Regents Outstanding Teaching Award. “I am a very passionate educator,” said Dr Restrepo. “Teaching respiratory care at a global and interprofessional level has been my motto from the time I started teaching.”

OR Management Softward Launched


Getinge globally launches Torin – a complete OR management software that helps surgical departments advance their surgery planning, execute efficiently on the schedule, and continuously improve the utilization of resources in and across collaborating departments. “Torin will make a difference for all hospitals that are looking to work more efficiently with their surgical planning and daily management of appointments. With Torin, Getinge provides one tool for both optimized long-term planning and reliable real-time execution. The goal is to minimize disruptions, reduce costs and improve patient care,” explains Charlotte Enlund, Vice President Integrated Workflow Solutions at Getinge. The user-friendly scheduling tool promotes planning, prioritization, and rescheduling of both day-to-day and long term appointments. Torin automatically checks for resource and staff conflicts to avoid double bookings as well as inconvenient and expensive waiting time. Additionally, it provides a business intelligence tool that enables management to identify trends and potential inefficiencies and act accordingly. Overall, Torin creates a calm environment for the patients, as they get to experience the reassurance of a well-organized hospital with surgeries that run on time and that always have the necessary resources and staff available in the right place.” Torin is available in three levels, that each focuses on different hospital needs. Torin Planning is the user-friendly planning tool with visual overviews for optimized surgery scheduling and increased OR utilization. Torin Progress level it up by also ensuring on-time execution of the daily schedule and complete documentation of all surgery steps. “Then we have Torin Optimization, which captures and provides access to an extensive business intelligence tool, allowing hospital management to learn from their data and further optimize the way their surgical department is run.”

MTI Enables Lab Quality Spirometry at Home


Monitored Therapeutics Inc. is focused on solutions for the management of diseases that affect respiratory function such as COPD, Asthma, Lung Transplant, ALS, and Cystic Fibrosis. We provide remote patient monitoring solutions for in-home use and to support pharmaceutical clinical trials. MTI’s GoSpiro Spirometer with Avatar-Assisted Technology delivers hospital lab quality Spirometry in the home without the need of a technician to go to the home, keeping both the patient and technician safe. “Lisa” is the world’s FIRST and ONLY Avatar based Spirometry Coach on the market, increasing measurement quality and providing patients with immediate post-test feedback. MTI’s unique solution solves the long-standing challenge of remote monitoring of respiratory patients. Lisa speaks 29 languages and all of the spirometry data is immediately available for viewing on the MTI CarePortal. The MTI CarePortal is a HIPAA and GDPR compliant cloud-based information portal designed for home and clinic site data collection and processing. “If the purpose of remotely monitoring respiratory patients is to obtain meaningful data that guides their care and prognosis...only the MTI GoSpiro has passed the more stringent test requirements for home use.” Kevin McCarthy, Member, ATS Pulmonary Function Lab Certification Program Committee and former Cleveland Clinic Pulmonary Function Lab Manager. In addition to GoSpiro with Avatar-Assisted Technology, MTI’s products also include the GoHome a telehealth communications hub for remote monitoring, communication, and care of patients at home. The GoHome provides simplified patient physiologic data collection for spirometry, blood pressure, SpO2, weight, FeNO, Glucose and other measurements. Contact MTI at to learn more about how the GoSpiro with Avatar-Assisted Technology and the full range of patient monitoring tools can solve your remote patient monitoring needs.

CAIRE expands global efforts to provide essential oxygen solutions


Bringing early experience to the fight against COVID-19, CAIRE President and CEO Earl Lawson issued this statement: “For more than 50 years, CAIRE Inc. oxygen solutions have been on the front lines of serving the global healthcare community — its top-tier health systems and medical institutions, clinicians, home care and durable medical equipment providers, the military and global aid nonprofits — all to provide the support required to care for patients who require life-sustaining or the therapeutic benefits of oxygen therapy. Today, we find ourselves playing a key role in fighting the novel coronavirus, COVID-19, on the world stage as it moves at a rapid pace touching the fabric of life in almost every country across the globe. Rest assured, the entire CAIRE team is “all-in” in meeting this challenge to provide its customers with a broad portfolio of equipment that can serve patients in need in hospitals, temporary treatment centers, in long-term care and even at home. Here is how we are bringing our experience to the task at hand. Providing access to oxygen delivery solutions for the critically ill, CAIRE offers a complete continuum of care of oxygen equipment solutions from the wearable portable oxygen concentrator designed for the individual suffering from Chronic Obstructive Pulmonary Disease to the commercial turnkey on-site oxygen generation system supporting the variable needs of a medical facility. As the COVID-19 virus has spread in recent weeks, we have seen a dramatic increase in demand for stationary oxygen concentrators, liquid oxygen vessels and commercial generators from our customers globally — particularly from those who are providing emergency aid in pandemic hot zones. Administering highly-concentrated oxygen therapy, delivered via a nasal cannula to an infected person, is one of the key supportive medical therapies identified by the World Health Organization to bring relief and healing to individuals whose respiratory function has been severely impacted by the virus. While most people with COVID-19 develop only mild or uncomplicated illness, approximately 14 percent develop severe disease that requires hospitalization and oxygen support, and 5 percent require admission to an intensive care unit. Expanding production to support our healthcare partners — The company has responded quickly to meet the rapidly increasing demand for its oxygen therapy solutions. With a heightened level of focus and intensity, CAIRE has added production shifts, extended work hours and is expanding production lines to address the increased need for oxygen equipment in its manufacturing facilities in Ball Ground, GA, Buffalo, NY, and Chengdu, China. Appropriate resources are also being allocated at its service and distribution facilities in Anjo, Japan; Langenfeld, Germany; Padova, Italy; San Diego, CA; and Wokingham, UK. CAIRE’s employees are in ongoing communication with our healthcare partners, our suppliers and local, state and government officials to ensure continuity of business and optimize access to our technologies. All of this work is being done with our ongoing commitment to provide products and service of the highest quality. Protecting our employees — When early reports began to surface regarding the highly-contagious coronavirus in Asia, CAIRE took swift action at its Chengdu location to comply with safety and quarantine recommendations made by the Chinese government. We learned valuable lessons in our China facility, that we have applied all around the globe to ensure continuity of supply of this critical equipment. Our decisive action enabled our production team in Chengdu to resume work in early February after a short down period, which is now making a difference in serving our European customers. Following the increase of virus cases in the US and Europe, CAIRE leadership made the decision to send all non-production CAIRE employees based at all of our facilities to work remotely while continuing all core business operations; and the remainder of employees in these plants continue production, but with new safeguards to protect them from potential exposure to the virus. These safeguards include regular screening before entering the facilities, heightened hygiene and sanitization schedules within the facilities, and structured social distancing on the manufacturing floor and in common areas. The situation is dynamic, and we are reacting to this new business environment in real-time. We are communicating at all levels of our business internally to rise to this unprecedented challenge, and externally to our suppliers and government leaders to ensure our essential manufacturing operations are not disrupted during this critical time. On behalf of the entire CAIRE organization, we appreciate the higher calling that this moment in time brings to us as a company and to each of us individually. We are ready and equipped to serve like never before because YOUR CAIRE MATTERS!”

Continuing Education for Students Enrolled in a Respiratory Therapy Program


Due to the restrictions placed on hospitals and schools during the COVID-19 (corona virus) quarantine, Intensive Care-on Line Network (ICON) is providing access to continuing education for all students currently enrolled in a respiratory therapy program. ICON will provide live webinars in addition to self-paced on line presentations covering basic topics to bridge the gap for respiratory therapy students while they are unable to attend clinical rotations at hospitals or classroom training. Topics to be covered include:

Vitalograph Publishes Infection Control Efficiency Rates for Respiratory Diagnostic Filters


In order to address concerns over COVID-19 exposure during respiratory function testing, Vitalograph has released a Certificate of Cross-Infection Efficiency for their Bacterial Viral Filters (BVFs) used during these procedures. The BV filters have a 99.999996% efficiency rate against bacteria such as MRSA and tuberculosis and a 99.999711% efficiency rate against viruses such as influenza and COVID-19. This extreme level of protection will help ensure that both patients and medical staff are protected from infection during testing for respiratory functioning. Every Vitalograph spirometer has such a compatible filter available and they often cost substantially less than other non-filtered mouthpiece options. As such, Vitalograph BVFs can play an important role alongside traditional safety measures like masks, gloves and good device hygiene to protect the respiratory care population from dangerous pathogens. “Our filters are specifically designed to stop the spread of COVID-19 and other infectious diseases during respiratory testing procedures,” said Troy Pridgeon, Vitalograph’s Executive Vice President of Sales and Operations in the US. “In light of the current pandemic, it is more important than ever for spirometry devices to be filtered and completely safe to use as the need for this type of testing is only likely to increase in the aftermath.” Vitalograph is one of the world’s leading providers of respiratory diagnostic devices and clinical trials. Their extensive range of respiratory testing devices include Pulmonary Function Test (PFT) equipment, spirometers, peak flow meters, COPD screeners, asthma monitors, and trainers for metered dose and dry powder inhalers. With a pioneering heritage spanning half a century, Vitalograph continues to produce innovations for safe and effective respiratory care and enhanced quality of life.

Getinge increases production capacity of ventilators by 60% to support the needs of global Intensive Care Units


Getinge has since the outbreak of the COVID-19 pandemic seen an increased global demand for ventilators, extra corporeal life support (ECLS) equipment and advanced monitoring for Intensive Care Units. To meet the global demand Getinge will temporary increase its production of ventilators by 60% in 2020 compared to 2019 at its production facility in Solna, Sweden. According to the World Health Organization, approximately 14% of COVID-19 affected people develop severe disease that requires hospitalization and oxygen support, and 5% require admission to an intensive care unit. To meet the increased global demand for various products and therapies, specifically ventilators, Getinge will temporary increase its production of ventilators at its production facility in Solna, Sweden by 60% in 2020 compared to 2019. “To meet the increased demand for ventilators we are adding a second production shift in our production facility”, says Elin Frostehav, Vice President Critical Care at Getinge. “The produced ventilators will be shipped globally based on current customer demands”. In 2019, Getinge produced more than 10,000 ventilators which translates into around 3 BSEK of its net sales (including service and spareparts). The production in 2020 has been up and running without interference, and Getinge will ramp up the production further, pending availability of supply parts from its sub-contractors. The ramp up will start immediately and be balanced in close collaboration with Getinge’s suppliers. “Our teams are doing their outmost every day to support our customers help saving lives”, Elin Frostehav continues. “I am very proud of our engaged sales teams and service technicians that on a daily basis are supporting our customers”. The expected increase in demand and production capacity of ventilators is expected to be accretive to Getinge’s result. Learn more about Getinge’s products on