08/26/2021 Chicago Boston doctor encourages innovations like helmet-based ventilation The global COVID pandemic allowed for medical innovations to grow, including the use of helmet interfaces to deliver non-invasive ventilation. That’s thanks, in part, to doctors like Dr. Zaid Altawil, adjunct assistant professor of Emergency Medicine at (Boston University School of Medicine) and an emergency physician at Boston Medical Center, co-founder of hack/ED, a medical hackathon that focuses on innovation in emergency medicine, and founder of an innovation group leading efforts to find technological solutions to COVID pandemic challenges. “It was the perfect opportunity for us to introduce a new technology that is not really commonplace in the United States and have patients benefit from it,” Altawil said. “It was the right-place right-time kind of situation.” Helmets for non-invasive positive pressure ventilation He’s talking about using helmets for non-invasive ventilation to treat COVID patients as the number of infected individuals increased dramatically in spring 2020. “We had already at that point started to do solutions at the hospital. We gave ourselves some good credibility as a group of doctors, nurses that were sort of thinking outside of the box, able to circumvent some of the challenges that were present at the time in order to get out solutions to the patients that needed them,” Altawil said. He received his MD degree from the American University of Beirut and completed his residency in Emergency Medicine at Boston Medical Center in Boston. Prior to residency, he completed a research fellowship in Global Health at Massachusetts General Hospital. He is a strong believer in integrating equitable technological solutions in health care and incorporating design thinking into medical education. “Similar to how other providers faced a similar challenge at the beginning of COVID, there was a feared shortage of ventilators. In some places in the country there was an actual shortage, in others there was more of a feared shortage and a need to sort of plan for that eventual shortage,” he said. “There was a concern, of course, with non-invasive ventilation being a way of aerosolizing infectious particles. And what we saw was that the rates of non-invasive ventilation plummeted drastically. So, we had a double sort of problem. … We had more patients who needed non-invasive ventilation and positive pressure, but at the same time, we had less use because of the worry of the infection risk. It almost quadrupled, in a sense, the issue at hand.” That led to the innovation group looking for ways to solve the problem. Colleagues in Italy were using helmet ventilation, Altawil said. Of course, the urgency of the situation played a part as the pandemic turned a drastic corner where doctors needed to act fast, he added. “For us, we had an intervention that we needed to apply. We had a patient population we knew could benefit from this intervention. We were able to do the background research to see that this is in fact effective elsewhere,” Altawil said. Motivating stakeholders The next step was adding the human factor. “What I mean, you need to be able to motivate a larger group of people to think along the lines you do and understand what motivates them,” he said. He recognized he and his team needed to develop a plan to make everybody’s job easier. Altawil and his innovation team identified primary stakeholders at Boston Medical Center and their needs, then set to work finding solutions. Physicians needed evidence, so Altawil reached out to colleagues at the University of Chicago Medicine who studied helmets in a patient population in 2016. Study author Dr. Bhakti Patel was able to provide the clinical indications and physicians’ protocols, which were put into a packet to tell the Boston doctors how helmet ventilation could help. Respiratory therapists faced a lack of supplies and needed to know how to divide up existing resources. Helmet ventilation decreases the use of critical care ventilators, which helps stretch resources. Nurses provided the most hands-on care to patients and needed to think about how to deliver patient care easily. They also care about their patients and don’t want to see them intubated. Helmets can reduce intubation while still making it easy for nurses to clean, feed, and care for patients. Central processing or sanitation teams are responsible for sanitizing and disinfecting units, so Altawil’s team got in touch with helmet manufacturers to set up protocols to reuse or dispose of helmet equipment. Leadership was very helpful, he said, recognizing the drastic situation and working with providers to explore alternative interventions. Altawil said it helped to have the infection control team on their side. They also had a COVID-specific budget that helped them get supplies quickly, bearing in mind general supply chain issues outside of the hospital. “Without leadership, we wouldn’t have been able to implement it as quickly,” he said. “We had champions in each area, and they’d come together,” Altawil said. They would choose patients where regular non-invasive ventilation with a face mask would have been difficult. Then, they would implement helmet-based NIV and hope others would catch on. It was the hardest part and depended on “word of mouth and having other providers witness you doing it easily,” he said. But it worked, despite the learning curve of a new interface during a global pandemic. “You never know what you don’t know. And I think in that particular instance in our implementation, that learning curve, we did not know as much about that as we needed to be able to tackle it or prepare for it at least,” Altawil said. Future of helmet-based ventilation As COVID sees a renewed resurgence with the delta variant, Altawil envisions broader use of helmet ventilation across the US. Implementation, however, would not be without its challenges. “I think people are very resistant to change anywhere, so there is the mantra of if ‘it’s not broke, don’t fix it.’ And now that face masks can be used again, people might be a bit more resistant to go to something else. I’m talking about hospitals that have not ever implemented helmet ventilation,” he said. “But on the other hand, if all of the data we have on helmets now comes to light and shows a much better intervention, then there is a chance for helmet ventilation to have much broader use.” The University of Chicago study in 2016 showed improved outcomes, he noted. “Now we have a lot more patients of anecdotal, observational data we can borrow from.” While helmets may not be a blanket intervention, they will be a helpful tool to have in the facility for patients for whom a face mask may not work, he said. Seeking solutions to medical challenges Altawil plans to continue seeking solutions for emergency medicine. He helped launch hack/ED in 2019 to address real-world emergency medicine challenges. “How do you find a problem, bring it down to its root, and then bring a solution quickly?” he asked. Nonmedical engineers and design students from 50 universities competed to solve medical challenges. Early in COVID, Altawil helped test and promote adapted snorkel masks for medical providers who didn’t have access to hospital PPE. They were available at no cost through maskson.org. He also worked on setting up IVs outside of rooms to limit how often staff had to change PPE, and they brought monitors to ventilators that didn’t have them. “All of the work that we’re doing now was inspired by that early work in global health,” Altawil said. “You have this idea that the United States is the peak of technology, and everything is greatly available, but sometimes, that’s not the case. We noticed that with our work in the global health field that sometimes the simplest things can have the greatest impact. So we need to combine both of these worlds. “I think people are catching on to the idea that things in medicine do not have to be very slow, and we can do things fast but also safely,” he said. Aurika Savickaite, MSN, RN, founder of HelmetBasedVentilation.com agreed, noting this was evident during the pandemic. “I believe the main lesson is if it’s simple technology, and if it can make your job simpler, it’s sold,” she said. Helmets fit squarely into that category of providing a simple technology that benefits patients and is cost-effective, she said. Video

08/10/2021 Vilnius, Lithuania The synergy between data science and medical knowledge changes the traditional approach towards patients who need mechanical ventilation. Information technology (IT) specialists using the latest data processing technologies provide medical personnel with new possibilities for decisions making and patients’ monitoring. A Lithuanian based company Acrux Cyber Service with the help of critical care specialists from the Republic Vilnius University Hospital has developed a novel system where all the data from sensors of the ventilator are collected and analyzed using various algorithms in order to adapt ventilation to individual needs as much as possible and ensure maximum safety and quality of mechanical lung ventilation. The new generation ventilators provide and display an enormous amount of real-time data for each breathing cycle. For a long time, all this information was used to a limited extent because the data collection, storage, and analysis was a complex and resource-intensive process. Devices for centralized management are quite expensive and have their own shortcomings in the data processing. Luckily, rapidly evolving data science using artificial intelligence technologies has found a way to process information and create an innovative system, where medical personnel are able to monitor the settings and parameters of each ventilated patient. This system uses machine learning algorithms to automatically detect errors, patient-ventilator asynchronies, and other discrepancies between the patient and the device and warns the hospital staff. Moreover, the system employs various predictive analytics methods to offer the most suitable lung ventilation technique for each patient. We talked about this novel system with one of the innovators Dr. Saulius Vosylius, a professor of medicine at Vilnius University and Head of the Center of Anesthesiology and Critical Care Medicine in the Republic of Vilnius University Hospital. Dr. Saulius Vosylius has over 30 years of experience in intensive care with his special interests in mechanical ventilation. “At the very beginning, the medical team decided which type and method of lung ventilation is the best for each patient. The initial parameters – volume or pressure, flow, frequency, oxygen fraction (FiO2), etc. are set by the physician. After setting up the device, a lot of data is generated by the ventilator itself. The problem is with data storage and processing because an enormous amount of data is provided during each inspiration and exhalation which is hard to process for medical staff. Of course, devices for centralized management of patient data exist but with a number of limitations.” Here, a solution was proposed by IT specialists. They came up with an idea to collect the data directly from the devices and send it to the server via a safe wireless connection. There the data is filtered and analyzed using various data science methods, including machine learning algorithms. Either real-time or summarized data could be accessed from the connected personal device – tablet, mobile phone, or laptop. It is important to note, that the data is completely depersonalized. The application does not store any personal information, yet the attending physician is able to fill in data on the dynamics of the patient’s health. Using this platform, the medical personnel can remotely monitor the parameters of ventilation of each patient in real-time or take a look at the summary report for certain period of time. The generated report shows how long the patient has been in the therapeutic range of ventilation, how often, and what type of asynchronies have occurred. Moreover, the system itself is able to detect discrepancies and trends in certain parameters which could be related to changing patient’s conditions. These features not only facilitate the work of medical specialists but also ensures maximum safety for patients. As Dr. Saulius Vosylius said, the biggest challenge during the ventilation process is ventilation-induced lung injury (VILI) so the risk for the development of VILI should be minimized. „If the airflow pressure is too high, the air is blown too quickly or there are discrepancies between patient respiratory forces and ventilator (so-called patient-ventilator asynchrony), the risk for VILI increases. The main goal of our project was to create a data analysis system which could detect early changes in ventilation parameters related to lung injury, find out the causes and suggest solutions to prevent VILI“, said the professor. The created system uses machine learning algorithms to recognize all irregular or incorrect respiratory cycles (e.g., the patient tries to inhale and the machine does not respond). In addition, these are not only recognized but the probable causes are provided when known (e.g. leak or excessive activity of the patient). During volume and pressure control ventilation it is also possible to calculate mechanical power, related to the risk of VILI. „An innovative artificial intelligence-based system, which is capable to process and analyze hundreds and thousands of different parameters of ventilated patients and provide the medical staff with the warnings and recommendations, is indispensable in intensive care units. Our system can warn staff about the changes in the ventilation process and make suggestions for ventilation methodology trying to adapt settings for individual needs. The early detection of deteriorating respiratory function enables us to make changes of ventilation settings for the best quality and the optimal treatment results“, said Dr. Saulius Vosylius. The professor believes that the current system could also be used to reduce human errors when irregular or incorrect respiratory cycles remain unnoticed. This would also be very useful for the less experienced medical workers or junior staff because ventilation parameters can be monitored remotely by the expert and useful recommendations are provided by the system itself. The software does not take on the decision-making function, but it provides the data which helps to make the best decision. „Mechanical lung ventilation is often seen as a method, but we should keep in mind that lung ventilation is a process that requires not only medical knowledge but also continuous monitoring and analysis of the ventilation parameters. We must assess the quality of the ventilation process in order to reduce hospital’s financial burden and save our human resources“, the professor noted. To date, the current system is being tested with invasive mechanical lung ventilation, but it is expected to also adapt algorithms for non-invasive lung ventilation methods to optimize non-invasive lung ventilation capabilities in the very near future. Dr. Jokūbas Drazdas, co-founder of Acrux Cyber Service is glad that the cooperation of data specialists and physicians has managed to create a unique and innovative system to facilitate the work of medical staff as well as maximize patients‘ safety. The new system is being tested in the Republic Vilnius University Hospital, where data from lung ventilation devices are analyzed and processed continuously. The developers emphasize the importance to involve more medical centers for wider recognition of the software. Acrux Cyber Service has started the process of certification of an innovative system in the EU, which is expected to expand the possibilities of using the system in Europe.

06/23/2021 Chicago Panicked by the global pandemic in early 2020, some Brazilian researchers found a way to help patients living in their state when they developed and brought to market a helmet design for non-invasive ventilation. Herbert Lima Santos da Rocha, an industrial designer since 2000, professor at University of Fortaleza (Unifor), and co-coordinator of lab research and innovation related to cities, teamed with others on a video call to talk about what they could do. News reports from Italy about COVID patients were grim. “We were expecting something bad,” Santos da Rocha said. “By what we were seeing in Italy, we were expecting something very bad.” During that initial meeting, they decided: “Let’s do something that would ease (the) impact on society.” First, they considered mechanical ventilators, but they faced an obstacle: Many of the companies and suppliers, such as those in China that they needed to rely on, were closed. By their second meeting, the team had landed on the idea of a helmet, like the ones used on old diving suits. They thought it was interesting that a patient could breathe oxygenated air, Santos da Rocha said. A team member, the pulmonologist Dr. Marcelo Alcantara, had worked with transparent helmets years before – an Italian model – to treat other lung diseases and suggested it could be used for COVID. The team agreed to pursue buying helmets, but that was impossible. The demand was so high, they never even got a call back from the manufacturers. At their next meeting, the team decided: Let’s make one. And so began the creation of Elmo, an assisted breathing helmet for patients with mild to moderate breathing issues. The team, based in the Brazilian state of Ceará, still faced the issue of not being able to get parts from other countries or even other states in their country. Instead, they decided to make the device using locally sourced supplies. “That was one of our first directives of our product. We need to find a solution to make it in our house,” Santos da Rocha said. The project was a joint effort between the University of Fortaleza (Unifor), the Federal University of Ceará (UFC), the Federation of Industries of the State of Ceará (Fiec), National Service for Industrial Training (Senai), and the Government of the State of Ceará, through the Secretariat of Health of Ceará (Sesa), the Public Health School of Ceará (ESP) and the Cearense Foundation for Scientific and Technological Development Support (Funcap). Injected, moldable plastic can be complicated and expensive. Even to make a mold would take months, Santos da Rocha said. They needed an efficient solution and came up with a simple two-ring design with a silicone neck seal. The design was easy to make into a mold and easy to produce 1,000 units, he said. Everybody was working at home at that time, Santos da Rocha said. He’d built a small home lab but didn’t have access to materials. He called a local store to buy a sheet of transparent PVC, picked it up, brought it home, and made the first version of the helmet using scissors and hot iron to weld the borders. As prototypes were tested, Esmaltec, a company in Ceará that makes refrigerators and stoves, was getting set up to produce the medical devices. The company has the machines and knowledge of the industrial process as well as “very good minds working there,” Santos da Rocha said. By 23 of June 2020, the helmets were being used on sick patients. One of the first was a woman aged 77 with oxygen saturation of about 90 percent, during the treatment with a face mask. After a few minutes of using a helmet, her saturation increased to 96 percent. During their months of production, they’d heard of other universities doing similar COVID work, even developing helmets, but they never were produced, Santos da Rocha said. “Many universities are used to research and publication,” he said, producing one unit to show the results. “But to make the product possible to be mass-produced, and finally be able to have a thousand units on the market, you don’t see that in university classes.” The other universities never reached the point of production, he said. “We had a team of people to make products for (the) market. “During research, tests, we were already contacting the government agencies with documentation to get the license to allow (us) to make the product,” he said. Esmaltec was doing its part to get ready for the production of a medical device. The prototype was simple, but “to deliver thousands of seals and thousands of hoods, all of that takes time.” Today, the company is able to produce around 500 units a day, and 9,000 helmets have already been delivered to hospitals, he said. The clinical trial results are excellent but not yet published, Santos da Rocha said. “Fifty to 60 percent of (COVID) patients that normally would be intubated, they got the helmet, and they recovered without needing to be intubated,” he said. Response from clinicians was excellent, as well, he said. The team prepared materials to train medical teams and show them the possibilities for using Elmo. Santos da Rocha listened in at a meeting a couple of months ago when physicians in Ceará related patient success stories about the helmets that nearly made him cry. “They (patients) were able to take a bath. Before that they were bedbound. They couldn’t do anything. Now they were able to take a bath,” he said. Patients who finished treatment posted videos on Instagram. “No one asked them to do this,” he added. “We heard a story a few weeks ago that was very interesting, touching,” Santos da Rocha said. A morbidly obese patient with COVID needed to be transported via ambulance from his home in the south of the state. He was very ill, Santos da Rocha said. Ceará is a large state, and the trip would take four or five hours. “They placed the helmet on him, and he made the whole trip from his small city to the capital by ambulance wearing the helmet,” he said. “We designed something thinking to use (it) inside hospitals,” but it also works in other conditions. “That’s great!” he said. Elmo is intentionally designed to have a smaller volume of 20L inflated to help with flow and reduce rebreathing CO2, Santos da Rocha said. Two tubes connect to wall air and oxygen provide 30L per minute per each tube. An antibacterial filter adds about 2 to 3 cm of water. At setup, clinicians use a manometer to test pressure inside the helmet. Manual flows, including a mixture of air and oxygen, are 40, 45, 50, 55, and 60, depending on the patient, he said. In some prototypes, they noticed that CO2 was higher. “If we placed the outflow of the helmet higher, the CO2 is heavier, the patient would breathe CO2 (more),” Santos da Rocha said, noting he’s seen many helmet designs around the world where he’s sure the patient is breathing CO2 because of this design flaw. NAZAreno Júnior [@nazarenojr_]. (2021, April 29). EMPATIA sendo exercitada na prática! O capacete Elmo é uma criação cearense! Ele ajuda muito no tratamento da Covid19, contribuindo. Instagram. https://www.instagram.com/p/COQYTmphmyC/ Some patients need a higher flow and higher oxygen supplementation. In cases where oxygen is in short supply, the nasal cannula can be used inside a helmet to provide oxygen while creating flow with just medical air. “We tried to find some solutions that would lower the oxygen consumption,” Santos da Rocha said, but they wanted to make the helmet available as soon as possible. “The project could have taken more months if we went to find solutions to small problems that we knew were there, but we needed to make this product available.” In December 2020, Brazil was at the beginning of the second wave, with the recording of 750 COVID deaths a day. During the apex of the second wave a month ago, it was surpassing 3,200 COVID deaths per day. “We’re working now at this exact moment, we have another team, working on a better version of the helmet, different materials for the membrane,” he said. The goal is to make it at a lower cost and to last longer. Helmets can be cleaned and used for four to five patients before they start to degrade. Additionally, they are considering accessories for the helmet, such as a manometer to track breathing frequency and pressures. A new accessory will replace the PEEP valve to regulate outside flux and control internal pressure in the helmet, Santos da Rocha said. It will be cheaper than a PEEP valve, costing cents of a dollar. The plan is for the design to be done in October, he said. The new design team involves students, as well. During the initial design process, Santos da Rocha shared weekly updates with his students. Coincidentally, they were learning about creating equipment for people with disabilities. He could tell them in real-time about the equipment they actually planned to produce. “Usually, you don’t have this kind of richness of information. Usually, a professor creates a problem for them to solve. In this case, it was a real problem appearing,” he said. “Some contacted me months after when it appeared in (the) media.” “That one?” they’d ask. “Yes, that one,” he’d reply. Pictures: NAZAreno Júnior [@nazarenojr_]. (2021, April 29). EMPATIA sendo exercitada na prática! O capacete Elmo é uma criação cearense! Ele ajuda muito no tratamento da Covid19, contribuindo. Instagram. https://www.instagram.com/p/COQYTmphmyC/ Herbert Lima Santos da Rocha (2020). Home photography

05/24/2021 Chicago Four Italian physicians who have been using helmets for non-invasive ventilation for years share their expertise in a 2.5-hour webinar, recorded May 20, 2021. The experts present their data and share up-to-date, valuable information with viewers. A recording will be available for a limited time. Presenters describe the proper clinical treatment of Acute Respiratory Failure with non-invasive interfaces for adult and pediatric patients in acute and sub-acute departments. According to organizers, the main purpose of the webinar is to develop knowledge and skills related to the timing and ventilation modes of non-invasive interfaces. Topics include: · CPAP: the neverending story · NIV in COVID and non-COVID patients · Helmet NPPV: Tips & Tricks · Role of helmets & masks in pediatric patients · A discussion among participants The webinar shares information about the indications and contraindications for the use of the helmet, the benefits of the new Total Face Mask with ZERO CO2 rebreathing, the best setup of free flow CPAP system, and bedside analysis and optimization of the patient-ventilator interaction during pressure support ventilation with helmet, both for adult and pediatric patients. Helmet use is thoroughly evaluated and compared to other common interfaces for non-invasive ventilation, including clinical effectiveness and patient comfort. Faculty participants are: · Giorgio Conti, A. Gemelli Policlinico, Rome · Claudia Brusasco, Galliera Hospital, Genoa · Roberta Costa, A. Gemelli Policlinico Foundation IRCCS Catholic University of Rome · Giuseppe Foti, San Gerardo Hospital ASST, Monza Link to the Video: https://www.fadstartpromotion.it/nivinterfaces/home/ NOTE: To access the webinar recording you have to register here: https://www.fadstartpromotion.it/nivinterfaces/registrati/ Link to the FAQ page: https://www.fadstartpromotion.it/nivinterfaces/faq/

05/03/2021 Chicago A new device that monitors pressure and airflow during helmet ventilation has been approved for use with COVID-19 patients. The PEEP-Alert Pressure and Flow Monitor received Emergency Use Authorization, or EUA, from the US Food and Drug Administration on April 28, 2021. The new device measures actual airflow and pressure inside a helmet during non-invasive ventilation or NIV. It sounds a loud alarm if the airflow or pressure is too high or too low during patient use. Additionally, if anything is disconnected or occluded, the device will alert clinicians that something is wrong with the helmet setup. The PEEP-Alert monitor was created by PEEP-Alert Technologies, Inc., a team of researchers, engineers, and inventors who work at Oregon State University and the University of British Columbia. They wanted to find a way to ensure proper airflow and pressure levels were maintained in helmets during patient use. PEEP stands for positive end-expiratory pressure. If pressure is too high, it can cause lung injury, but the pressure that’s too low may not be effective. The continuous positive airway pressure, or CPAP, delivered via helmet also needs to provide fresh air to wash out the exhaled carbon dioxide. The new device provides visual and audible alarms if pressure or flow are outside of the parameters set by clinicians. It connects to the helmet outlet and can provide up to four days of continuous monitoring before it needs to be recharged. It is compatible with existing helmets and can be easily disinfected and reused. “This is great news. We have this new accessory for the helmet CPAP setup with alarms. It’s going to be easier for clinicians to monitor patients during the helmet-based ventilation therapy,” said Aurika Savickaite, co-founder of HelmetBasedVentilation.com The PEEP-Alert has been approved for use in Canada as well, and the emergency authorization allows it to be used in other countries. The FDA previously granted EUA for two helmet designs for NIV use. However, because many clinicians aren’t familiar with helmet-based ventilation, they haven’t been used as often. Questions arise about how to set up helmets and use them successfully. Dr. John P. Kress, a professor of medicine and director of the Medical Intensive Care Unit at the University of Chicago Medicine, a not-for-profit academic medical health system, recently shared some tips and best practices for helmet use, including the benefits of PEEP. Kress was part of a study at the University of Chicago, published in 2016, that found patients with acute respiratory distress syndrome, or ARDS, who received helmet-based ventilation had lower mortality rates and fewer days in the hospital than patients who received invasive ventilation with an endotracheal tube.

04/19/2021 Chicago Helmet use to deliver non-invasive ventilation, or NIV, has become more common in the United States because of COVID-19. A University of Chicago pulmonary medical doctor shares tips and suggestions for helmet use to treat patients who have COVID as well as others in respiratory distress. Dr. John P. Kress is a professor of medicine and director of the Medical Intensive Care Unit at the University of Chicago Medicine, a not-for-profit academic medical health system. Kress participated in a University of Chicago study published in 2016 on helmet use in patients with respiratory failure. It showed the benefits of helmet NIV in lowering mortality rates and hospital stays. But the one helmet that they used at that time was not easy to operate, so there was little demand for it, and European helmet manufacturers had no big interest in marketing their product here. Since COVID, the FDA has issued Emergency Use Authorization, or EUA, approval for two helmets to deliver NIV that are easier to use and more comfortable for patients. The new generation helmet neck rings come in many different sizes and doesn’t need to be cut to size. An inflatable pillow goes around the neck to improve the seal. Helmets also have better access to patients’ faces to suction their mouths, give oral fluids, and perform oral care. Like other treatments, as technology advances, the use increases gradually. Back in the 1990s, Kress said, people were skeptical of using BiPAP, a type of ventilation delivered via face mask, because they weren’t familiar with it. There are two ways to use a helmet, Kress said: Connect the helmet to a ventilator and use pressure support mode to deliver bi-level positive airway pressure. Use the helmet to deliver continuous positive airway pressure, or CPAP, by connecting gas flow from the wall, not a ventilator. A helmet used during pressure support ventilation (PSV) can create challenges like patient-ventilator asynchrony, which is different from problems caused when tracheal tubes are used, Kress said. “The helmet has high compliance, and so when the pressure from the ventilator is given during inhalation, what it initially does, is it inflates the helmet and moves the helmet up, with the neck ring being the most compliant part of the helmet. It (air) doesn’t go into the patient’s lungs, because the patient’s lungs are typically much less compliant than the helmet,” Kress said. In a pressure support mode, the ventilator continues to give the pressure until it’s programmed to stop, he said, which for most ventilators is 25 percent of the maximum flow. “That’s a long time when the maximum flow is very high because the helmet is so compliant,” Kress said. Two things have been shown in previous work by other helmet NIV experts to improve the synchrony between the patient, the ventilator, and the helmet, Kress said. Adjust the onset time on the ventilator from the default of 200 milliseconds to 50 milliseconds, which means the breath gets pushed in quicker. Increase the offset time, which is typically a percentage of the maximum flow, from a standard 25 percent or 35 percent to 50 percent. That makes the breath end quicker, Kress said. “That more rapid delivery and short time of inhalation before the breath ends has been shown in previous work – and we did it in our study – to improve synchrony substantially,” Kress said. Additionally, you can reduce the compliance of the helmet a little bit to help with synchrony, he said, by reducing the amount of movement upward. Sometimes the helmet “looks like a bobblehead going up and down,” he said. If you put something on top to hold it in place, the helmet won’t be as compliant, and you see less dyssynchrony. Using straps under the armpits can reduce the tendency of the helmet to bob up and down, he added, and some helmets come with straps on the top of the hood. For patients with hypoxemic respiratory failure, the key to helmet CPAP use is the fresh gas flow of at least 50 liters per minute, Kress said, to make sure you wash out the exhaled carbon dioxide. “What we usually do is just hook the helmet directly up to high-flow nasal cannula apparatus, which can give whatever FIO2 you want, at 60 liters a minute, which will for certain effectively wash out carbon dioxide. Then … you put a PEEP (positive end-expiratory pressure) valve on the expiratory limb.” When it comes time to wean a patient from the positive pressure of the helmet, Kress suggests you can open the front access port of the helmet – new helmet designs have a large access port to reach the patient’s face easily – and put a high-flow nasal cannula on the patient. Disconnect the gas flow from the helmet and hook it up to the high-flow nasal cannula to see if the patient is ready to come off positive pressure. “It buys you a little bit of time when transitioning from one to the other,” Kress said, and it’s much easier than taking off the entire helmet and neck ring. Caution, don’t connect the helmet to the ventilator and set it to CPAP mode. Because if you do that, the patient will rebreathe CO2. Only ventilator high flow modes can be used with the helmet interface. Recent helmet studies of COVID patients found an improved ability to stay off the mechanical ventilation, Kress said. “I think the key thing that makes the helmet different from a high-flow nasal cannula is the need for PEEP,” he said. “One thing interesting was that there has been this description written about, since COVID became such a problem, is the different phenotypes of COVID,” Kress said. One phenotype of COVID is seen with conventional acute respiratory distress syndrome, or ARDS, which is airspace filling, very stiff lungs, and the lungs are amenable to PEEP with recruitments, he said. “But then there’s this other curious group of COVID patients that don’t seem to fall into that biological, physiological category, that is high compliance, … and those patients don’t seem to benefit much from PEEP,” he said. Kress referenced a study by D.L. Grieco and colleagues of COVID patients using helmet NIV vs. high-flow nasal oxygen. The study didn’t make a distinction between the two COVID phenotypes, but overall, there was a benefit for the helmet group with PEEP. “PEEP will improve airspace lung recruitment,” Kress said, but “not everybody with COVID has that.” Helmets are an important component to manage patients, Kress said, particularly COVID patients who have airspace flooding that’s visible on the X-ray. Kress said he had a few patients who were going to be intubated, so they tried the helmet and had remarkable improvement. “You put the helmet on, and the patient’s respiratory rate goes from 40 to 16, their saturation on 100 percent high flow nasal cannula goes from 88 to 97 percent and their FI02 goes from 100 percent to 60, and that happens in 30 minutes. Those are the patients for whom the helmet is most clearly beneficial,” Kress said. But Kress warns to watch the patient carefully. “In the first 30 to 60 minutes (of helmet use), if there isn’t a substantial improvement, you should think twice and identify this person as somebody who isn’t going to benefit,” he said. “I think the biggest error people make, and they make the error with noninvasive mask ventilation, too, BiPAP, is they put the BiPAP on, the patient is clearly not performing well – high energy expenditure with breathing, saturation may be in quotes acceptable, but the patient is failing.” With a helmet or face mask, the patient’s ability to communicate is impaired. You can’t hear them as well, he said, and their saturation may be OK because you’re giving 100 percent oxygen. “But if the patient is working extremely hard to breathe, the saturation is largely irrelevant. And that person needs an advance in the care to perhaps an endotracheal tube,” he said. “Those patients have a very poor prognosis. “Not everybody is going to benefit from the helmet. Some patients will need to be intubated,” Kress said. “In hindsight, some won’t benefit. Some won’t benefit from being intubated. Unfortunately, those people usually die.” Kress has had some patients use a helmet for a week or longer. He also uses sedation from time to time for patients using helmet ventilation. Intubated patients traditionally were routinely sedated the moment you put the endotracheal tube in, which Kress doesn’t think is necessary in some cases but has been practice for many years. “With the helmet, we don’t begin with the idea focused on sedation but rather focused on alleviating the patient’s breathlessness,” he said. If a person is short of breath and distressed, and the helmet improves that, sedation may not be needed. Kress may use dexmedetomidine to alleviate distress, but if it’s not effective, those patients usually aren’t going to tolerate the helmet very well, and it’s risky to use other medications, he noted. Another recent study from A. Sforsa and colleagues showed a small group of patients with hypercapnic cardiopulmonary edema benefited from helmet treatment. Kress agreed that helmets could benefit hypercapnic hypoxemic patients. “If they have both problems, typically the hypercapnia is an epiphenomenon, meaning when your lungs are stiff from airspace flooding, you are going to be more inclined, in all comers, to have trouble. Because when your lungs are stiff and airspace filled, the energy expenditure with breathing is increased. It’s harder to breathe. If your lungs are wet like a sponge, it’s harder to breathe and eliminate carbon dioxide. And so the CO2 rise is usually a reflection not of bronchospasm or things of that sort but rather energy expenditure, because you’re breathing with your lungs being so flooded. And so the ability to eliminate carbon dioxide is impaired. “So it’s not uncommon to see patients with pulmonary edema of any type also have rising CO2, especially when you’re looking at people that are debilitated, weak, or essentially just running out from an endurance standpoint,” Kress said. Helmets sometimes are used for patients with chronic obstructive pulmonary disease, or COPD, as well. However, COPD patients generally benefit so well from BiPAP there isn’t as much positive impact from the helmet, he said. “But the incremental benefit, in my opinion, is driven more from the benefits of PEEP and airspace recruitment, which is, frankly, why, a decade ago, when we first started thinking about the idea of the helmet for ARDS, we chose to target that population because it seemed like they’d be more amenable to benefiting.” Currently, Dr. Bhakti Patel, John Kress, and the team at the University of Chicago Medicine are doing research to evaluate the efficacy of helmet NIV in reducing the duration of invasive mechanical ventilation in order to minimize ventilator needs during the COVID-19 pandemic. Watch a recorded on April 15 2021 video interview with Dr. John P Kress who shared his experience on the use of respiratory assist helmets for reducing the need for invasive mechanical ventilation in COVID-19 patients suffering from ARDS. Video

04/14/2021 Chicago In March 2020, as COVID-19 was declared a global pandemic, a group of volunteers banded together in Canada to create access to medical equipment around the world through open-source design solutions. “When we saw pictures and news articles in Italy, we thought to ourselves, ‘Well, we haven’t seen these methods of helmet-based ventilation in North America. Why is that? And why has Italy been using it widely in managing its COVID-19 patients?’” explained Vionarica Gusti, a team leader on COSMIC Medical’s bubble helmet project. As a result, a non-rigid ring helmet was designed for non-invasive ventilation (NIV). COSMIC Medical, based in Vancouver, BC, is a group of volunteer students and professionals who are committed to open-source design solutions for COVID. COSMIC Medical reached out to Aurika Savickaite, co-founder of HelmetBasedVentilation.com, in April. Savickaite connected with team members for an interview and updates on the helmet project. Gusti and her team had been working on a bag-mask ventilator but switched to a helmet design when they saw them widely used in Italy and read the University of Chicago study which showed lots of benefits of helmet-based NIV for patients with acute respiratory distress syndrome (ARDS). COSMIC Medical volunteers tried several designs but found them challenging because of rigid neck rings that required a large 3D printer or molding to create them. Gusti reached out to DIY Packraft, an inflatable raft maker in rural British Columbia for prototyping advice. The first functional prototypes of a soft neck collar that is heat-sealed to the bubble helmet were connected using a hairstyling flat iron to a plastic hood prototype from SEI Industries, Gusti said. “Helping out with the testing of the non-rigid ring design, I also saw that it was far superior to the rigid ring,” said project co-leader Arpan Grover. “We noticed that because (we were) 3D printing our designs there was a lot of variation in terms of actually clipping the two pieces together, which caused a lot of leakage through the neck seal. We didn’t want that because it was geared toward COVID patients, and we didn’t want aerosols to be leaking from the helmet at all. We wanted to minimize leakage as much as we possibly could.” The soft ring design reduces leakage to close to 2 percent, he said. The new design was simpler and better for the team, Gusti said. They could create prototypes in-house and test them right away. The team settled on biocompatible thermoplastic polyurethane (TPU) to create both the helmet and the neck seal. It needed to be transparent and not have a plastic smell. It’s a little more expensive, Gusti said, but because of the elasticity of the material, it makes a good gasket with whatever port is used. “We also noticed that using the TPU as a neck seal was very comfortable,” Grover said. “It was very easy to get on, as well, and surround the neck, even for four hours, it was very comfortable.” “Because of its very thin TPU, it attaches (to) your neck without constricting it,” Gusti said. The positive pressure of the helmet makes the seal very good, she added. The team plans clinical trials of the helmet and seeks fast-track options to produce it. Large-scale manufacturers with proper certifications are needed to partner with the team and bring the design to where patients need it. Helmets have been approved for use in NIV in Canada and the USA. Additionally, the design is open source for anyone to use. The simple design means it can be produced in other countries, especially developing countries, Savickaite said. Shipping to other countries is cost-prohibitive, Gusti added. Instead, other countries should manufacture their own. She said it costs about $100 (CAN) to produce one helmet. Large-scale manufacturing may bring the price down, she said. Savickaite praised the team and its work. “You have a great helmet design that’s comfortable to use, and you’re sharing it with the world. Amazing.” Video Link to helmet Design Files: https://github.com/COSMIC-medical/bubble-helmet

03/16/2021 Chicago This is a video review of two Harol Hoods for Non-Invasive Ventilation made in Italy. More information provided by the manufacturer here: Helmet Fast-Har and Helmet One-Har More Videos from Harol: Harol helmets are not FDA approved in the US. Other countries can order directly from the manufacturer here.

01/25/2021 Chicago I was delighted to discuss and share my expertise about a helmet NIV with Mr. Ismael Cordero, Senior Project Engineer at Emergency Care Research Institute (ECRI) back in July 2020. Our January 13, 2021, the ECRI team organized and recorded a webcast about NIV helmets. ECRI is the only organization worldwide to conduct independent medical device evaluations, with labs located in North America and Asia Pacific. ECRI is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality and a federally certified Patient Safety Organization by the U.S. Department of Health and Human Services During the webcast, speakers shared their experience and focused on the use of respiratory assist helmets for supplying supplemental oxygen and reducing the need for invasive mechanical ventilation in COVID-19 patients suffering from acute respiratory distress syndrome. Speakers: Andrew Furman, MD, MMM, FACEP, Executive Director, Clinical Excellence, ECRI Bob Kopotic, PhDh, MSN, FAARC, Critical Care Senior Manager, Clinical and Medical Affairs, Edwards Lifesciences, LLC Maurizio Cereda, MD, Associate Professor, Critical Care Anesthesiology and Department of Radiology, Program Director, Adult Critical Care Medicine Fellowship, Co-Director, Surgical ICU, University of Pennsylvania, Perelman School of Medicine Michael J. Frazer, BS, RRT, CPFT, Associate Administrative and Clinical Director Respiratory Therapy and Pulmonary Diagnostics, Hospital of the University of Pennsylvania and Perelman Center for Advanced Medicine Ismael Cordero, BS, Senior Project Engineer, Device Evaluations, ECRI Marc Schlessinger, RRT-NPS, MBA, FACHE, Senior Associate, ASG, ECRI Jason Launders, MS, Director of Operations, Device Evaluations, ECRI ECRI is currently evaluating 4 helmet designs from the U.S. suppliers: Amron, Intersurgical, Sea-Long, and Subsalve. View the session recording, including live Q&A, plus supplementary materials:

10/26/2020 Chicago 06/07/2021: Open-source OxyJet flow-generator design available here. A university faculty and a team of research students have created a low-cost device to provide non-invasive ventilation using a helmet or mask and an oxygen source. The OxyJet nozzle uses jet mixing or the “venturi” effect to pull in environmental air to generate a huge amount of flow. The plastic part can be 3-D printed and connected to a high-pressure oxygen tank using standard connecting equipment. The device works with a snorkel-type or CPAP mask, or a helmet. Dr. Taufiq Hasan teaches in the Department of Biomedical Engineering at Bangladesh University of Engineering and Technology (BUET) in Dhaka, Bangladesh. As the COVID-19 pandemic took hold, they went to work trying to develop a low-cost system that would work in developing countries like their own. Aurika Savickaite, a co-founder of HelmetBasedVentilation.com, interviewed Hasan and his team. “At the beginning of the pandemic, we’ve all seen this situation where everybody was saying there’s a shortage of ventilators,” Hasan said. “We asked ourselves, ‘What can we do? We are biomedical engineers. We need to do something.’” Critically ill patients (about 5 percent of all patients) need invasive mechanical ventilators, but the mortality rate is high for intubated patients, he said. Severely ill COVID-19 patients (14 percent) need a high flow oxygen system or noninvasive ventilators. “These devices are very expensive, and so we wanted to develop low-cost non-invasive ventilators,” Hasan said. The team decided to focus on CPAPs (continuous positive airway pressure) because they could make a bigger impact by reducing ICU admissions, he said. Bangladesh presents unique challenges: Unreliable electric power, cylinders often the only source of oxygen – even in hospitals – and scarcity of medical devices. They tried a couple of designs but realized it needed to be lower cost and simpler. The OxyJet was created. The cost for the system is $50, without the helmet. It provides a high flow with a PEEP (positive end-expiratory pressure) of up to 20 cm H2O. It can offer a maximum flow of 100 LPM, but is optimized at 65 LPM. If you need a really high oxygen concentration, it’s necessary to use two tanks. OxyJet needs no electricity, and it’s very easy to use. The team created a user manual to go with it. Clinical trials are planned at Dhaka Medical College and Hospital (DMCH) in Bangladesh, comparing OxyJet’s high flow with high-flow nasal oxygen, Hasan said. “If that actually is established then … that means you can make huge savings, because our device, overall, it costs around $50, and you can have high flow nasal oxygen devices costing up to $5,000,” Hasan said. When the device is approved, the team plans mass production with the help of an industrial partner. Its low cost could be beneficial in other developing countries, he said. Team members noted the snorkel masks have more air leaks than helmets, but helmets are not readily available and are more expensive. However, helmets reduce aerosolization and are more comfortable, especially for extended wear. The team seeks sponsors and helmet donations. Savickaite noted the “biggest issue that the people, especially in underdeveloped countries, have is to create that high oxygen flow that’s required for helmet ventilation. How to increase oxygen and keep flow at 60L or above per minute, to prevent CO2 rebreathing, that can be challenging,” she said, noting it should be used in a hospital setting. She also suggests the OxyJet could be used when transporting patients by ambulance or in the ER. “If you can put this on the patient early in the disease, early in respiratory distress, you may avoid the progress of this, have fast recovery and the avoidance of intubation,” she said. Hasan and his team are excited, but they wish they had reached this point earlier. “We faced a lot of challenges,” he said. They would order parts, but they weren’t delivered. They didn’t have adequate testing equipment to measure parameters in the lab. “We hope to get this working, no matter how long it takes. But it is what it is. In a developing country, you have different challenges, which are not present in developed ones, especially when you are trying to create something new. So, it took some time,” Hasan said. Savickaite offered praise for OxyJet: “I love it. It’s simple, it’s cheap, and it works!” Video More info about the device: "OxyJet CPAP: Design and Evaluation of a Low-cost Non-Invasive Ventilator for COVID-19 patients" Md Kawsar Ahmed, Meemnur Rashid, Kaisar Ahmed Alman, Farhan Muhib, Saeedur Rahman, and Taufiq Hasan. Department of Biomedical Engineering (BME), Bangladesh University of Engineering and Technology (BUET) Dhaka - 1000, Bangladesh. Email: taufiq@bme.buet.ac.bd Update 06/07/2021: Paper published by the team: OxyJet: Design and Evaluation of A Low-Cost Precision Venturi Based Continuous Positive Airway Pressure (CPAP) System Md. Kawsar Ahmed, Meemnur Rashid, Kaisar Ahmed Alman, Farhan Muhib, Saeedur Rahman, and Taufiq Hasan Open-source OxyJet flow-generator design available here. Update 12/11/2020: Initially, the team wanted to open-source the design but this move will slow the mass-production of the OxyJet in Bangladesh. For that reason, OxyJet is not an open-source design.

11/19/2020 Chicago Helmet based non-invasive ventilation (NIV) study at the New York hospital shows this treatment saves lives among the sickest of COVID-19 patients and adds to a growing list of research. Oxygen hoods demonstrate significant improvement in oxygen saturation and prevent intubation in some people with acute respiratory distress, according to Dr. Owen O’Neill, MD, MPH, FUHM, founding medical director of the Department of Hyperbaric Medicine at Phelps Hospital Northwell Health. “Mechanical ventilation and mortality rates were reduced by about 27 percent by using the hoods,” O’Neill said. “Our study of the hoods was actually begun around the beginning of April (2020) when we had a very high incidence of COVID in the hospital,” O’Neill said. The medical staff got interested in the hoods because they can deliver 100% oxygen without any leaks and reduce the virus spread (helmet NIV creates a closed system). Results of the study, “The use of hyperbaric oxygen hoods as an alternative to conventional high flow oxygen delivery systems during the COVID pandemic,” were shared Nov. 12, 2020, at Associate Council Town Hall. Study author O’Neill is an assistant professor of medicine at New York Medical College and an assistant professor of emergency medicine in the Division of Undersea and Hyperbaric Medicine at Upstate Medical University. He has been practicing the specialty for more than 30 years. He is also the President & CEO of US Hyperbaric Inc., America’s leading commercial diving and tunnel medicine team. This study involved a total of 136 patients; 58 received the hood intervention (Helmet CPAP) and 78 were in a control group. The control group included patients seen prior to hood use, and randomization wasn’t possible since it would be unethical to deny all treatment options to patients. Hoods averted imminent intubation and mechanical ventilation in all patients. For patients about to be intubated, hood use allowed them to avoid or delay the intubation, O’Neill said. The mean improvement in post hood oxygen saturation was 8.8%. Of the 78 in the control group, 37 (47%) needed intubation. Of the 58 who received helmet CPAP, 23 (39.7%) got intubated. “These patients are the sickest ones,” Dr. O’Neil said. “Still, a high percent avoided intubation,” he added. “We achieved a 27 percent risk reduction of the need for intubation,” O’Neill said. “The problem with this was it wasn’t statistically significant. … Although we didn’t reach a level of statistical significance, we did have a 27 percent risk reduction, so you can’t argue with that.” Mortality rates also showed a 27 percent risk reduction. In the control group, 54 of 78 patients died, (69%); 36 of 58 in the hood intervention group died (62%). The goal of any intervention was to save lives. “When we look at intubated patients, they have up to a 97% mortality rate, so we really want to try and do whatever we can to prevent people from needing intubation,” O’Neill said. “By not intubating them right away, we decreased their mortality chances. We also gave them medications that were getting a chance to work.” Helmet aka hood based NIV and mechanical ventilation allow patients recovery time while medications are used to treat the virus. “It’s the bridge,” O’Neill said, giving “time for the patient to recover.” O’Neill said they received positive feedback from some of the survivors. “Of the ones that survived, we had a number of letters back thanking us for keeping them from being intubated. They can remember how uncomfortable they were. And when they got the hood on, they became a bit more comfortable, again enough to hold them over,” he said. O’Neill and hospital staff faced challenges by conducting a study during a pandemic. Hospital leaders were on their side, and one of the benefactor’s daughter provided access to 100 hoods. Staffing in the respiratory department was the most difficult challenge, he said, so the hyperbaric department halted treatment to allow staff to work on the floor and help the respiratory department. O’Neill said it’s important to plan early. “Make the plan and follow your plan. Try and get everyone on board to follow the plan.” He suggests early meetings with pulmonary, critical care, and anesthesia departments. “Break out the data and show them the studies,” O’Neill said. “There’s definitely something pointing to the fact that the hood might be the better route to take.” There’s still more work to be done. O’Neill wants to conduct a prospective randomized trial with other colleagues and hospitals who use the different interfaces for high-flow positive pressure delivery, such as face masks, nasal cannulas, and hoods, and see who does better. If multiple places participate, it would make the study statistically significant, he said. O’Neill said his hospital is meeting to decide where and when oxygen hoods or helmets should fit into hospital policies. “I think they are still looking at using the hoods when patients are getting bad. We’re trying to institute it as primary usage for patients having respiratory difficulty. I’d like to see the hoods used right away,” O’Neill said. Video Congratulations to Dr. Owen J. O'Neill and his team! Their study was published on February 11, 2021, in the Respiratory Medicine journal.

11/19/2020 Chicago This is a video review of the Haven Hood for Non-Invasive Ventilation made in India by Phoenix Medical Systems Helmets are made of medical-grade vinyl, PU, and medical-grade silicone. You can send your inquiry directly to the manufacturer here. Pictures shared by Phoenix Medical Systems: Recent feedback from the clinicians in India: "The Phoenix Haven Hood is the best innovative and remarkable product for covid and non-covid patients who require high PEEP. (eg.ARDS). It helps to protect the patient and caregivers, as it has a facility to filtrate the patient's exhaling air. This haven hood benefiting the patient as more intuitive and less cumbersome." Dr. Ram Kiran, Homi Bhabha Cancer Hospital Research Centre, Visakhapatnam "Haven Hood is a very good device for cooperative patients. It is most useful for moderate COVID symptoms patients. It helps to improve the saturation level for the patients. Also, it is greatly beneficial to caretaker as there is no aerosol dissemination." Dr Vijay Sekhar, Sai Bhaskar Hospital, Guntur "Haven Hood is a very good option for non-critical cases. It is maintaining SpO2 level very well. The patients feel more comfortable to use and they can consume food at any time." Dr. Arif, Medway hospital, Chennai