Alere

Getinge

COVID-19 NEWS

Zenith Award Handed Out

09/17/2020

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 www.aerogen.com.

Free Spirometry Training Offered

09/17/2020

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 https://nddmed.com/pulmonary-resources/training/live-training. 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 www.nddmed.com.

Patients Survive Ventilator, But Linger in a Coma

08/31/2020

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

08/31/2020

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

08/31/2020

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

08/31/2020

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

08/31/2020

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 capsuletech.com, or contact Capsule Technologies at 1-800-260-9531 orsupport@capsuletech.com.

Lung Simulators Produced to Fill Shortage.

08/19/2020

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

08/17/2020

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

08/10/2020

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

08/04/2020

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 https://www.siemens-healthineers.com/laboratory-diagnostics/assays-by-diseases-conditions/infectious-disease-assays/cov2g-assay.

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

07/30/2020

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

07/30/2020

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

07/27/2020

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?

07/15/2020

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

07/15/2020

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

07/15/2020

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

07/15/2020

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

07/15/2020

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

07/08/2020

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.
[Read more (PDF)...]

Independent Testing Confirms Human Coronavirus Efficacy

05/28/2020

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

05/28/2020

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

05/28/2020

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

05/28/2020

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

05/28/2020

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'

05/16/2020

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

05/16/2020

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

05/16/2020

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

05/13/2020

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

05/05/2020

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

04/28/2020

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

04/16/2020

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

04/13/2020

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

04/08/2020

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

04/07/2020

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., https://westmedinc.com, 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. https://westmedinc.com/circulaire-ii/

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

04/06/2020

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 https://www.siemens-healthineers.com/rapidpoint500e.

Company Ramps Up Production

04/06/2020

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 www.getinge.com.

Should CPAP Therapy be used with COVID-19 Patients?

04/03/2020

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

04/02/2020

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

04/02/2020

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

04/01/2020

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 clinicaltrials.gov.

Cuff Pressure Management While Keeping a Safe Distance

03/31/2020

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 https://www.tracoe.com/en/products/technic/article/article/ref-730-5-tracoe-technic-smart-cuff-manager/

Fighting COVID-19 is Our Mission

03/30/2020

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 https://www.ingmarmed.com/covid19/ for more details.

Protecting Healthcare Workers from Patients with COVID-19

03/30/2020

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

03/30/2020

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

03/30/2020

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 Medtronic.com/openventilator. 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

03/27/2020

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

03/27/2020

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

03/27/2020

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

03/27/2020

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 www.coventors.com.

Tube Holder Ready to Use

03/26/2020

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

03/26/2020

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

03/26/2020

GM and Ventec Life Systems, in cooperation with StopTheSpread.org, 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, StopTheSpread.org 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

03/26/2020

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

03/26/2020

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

03/26/2020

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

03/26/2020

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 Hillrom.com 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.

 

 

RT NEWS

Company Earns Another Ventilation Industry Award

10/21/2020

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

10/19/2020

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

10/12/2020

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 AerosoLessMedical.com 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

10/06/2020

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

10/05/2020

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

10/01/2020

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

09/30/2020

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

09/30/2020

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

09/15/2020

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

09/15/2020

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

09/15/2020

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

09/11/2020

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

09/01/2020

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 ResMed.com/AirTouchN20.

High-Frequency Oscillatory Ventilation in Infancy Shows No Lasting Benefit

08/17/2020

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

08/17/2020

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

08/05/2020

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

08/04/2020

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

07/30/2020

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

07/30/2020

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

07/30/2020

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

07/30/2020

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

07/30/2020

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

07/20/2020

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

07/15/2020

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

07/15/2020

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

07/14/2020

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

07/07/2020

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

07/07/2020

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

07/05/2020

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

06/30/2020

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

06/30/2020

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

06/30/2020

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

06/30/2020

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

06/30/2020

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

06/29/2020

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

06/25/2020

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

06/24/2020

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

06/20/2020

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 www.masimo.com. 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

06/16/2020

The SecureET Neonatal Endotracheal Tube Securement Device from Westmed (westmedinc.com) 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

06/15/2020

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

06/15/2020

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

06/15/2020

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

06/15/2020

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

06/15/2020

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

06/15/2020

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

06/15/2020

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

06/15/2020

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

06/03/2020

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

05/28/2020

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

05/23/2020

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

05/21/2020

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

05/16/2020

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

05/16/2020

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

05/05/2020

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

04/29/2020

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

04/17/2020

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

04/13/2020

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

04/13/2020

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 info@monitoredrx.com 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

03/25/2020

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

03/20/2020

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

03/19/2020

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

03/18/2020

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 www.getinge.com.

 

 

COVID-19 SPECIAL NEWS