10/28/2020 Chicago As the United States continues to battle increasing cases of COVID-19, global efforts to fight the virus continues to unite manufacturers and medical personnel worldwide. A CPAP hood that got its start in Italy in 2001 has received the FDA Emergency Use Authorization (EUA) approval for its use in hospitals in the United States. It was a long – and perhaps sometimes bumpy – road to obtain these approvals, but all worth it in the end, according to Marco Finotti, Critical Care Product Manager at Intersurgical Complete Respiratory Systems, a UK-based company. Intersurgical developed the first helmet in 2001 as the available CPAP masks were exceedingly difficult to maintain the seal and uncomfortable for patients. “Italian physicians were looking to solutions to improve the CPAP quality for their patients in the ICU … They reached out to the small company StarMed … So together, with them, we designed the first CPAP hood,” Finotti said. The hood was connected to free flow gases, high flow blenders, and venturi flow drivers. Working with clinicians, they determined what components worked best for the patient and improved the efficacy of CPAP. Meantime from about 2002 to about 2005 clinical studies highlighting the advantages of the interface as well as important technical aspects, helped determine the best use of the new concept product. One example above all was the definition of the minimum flow needed to washout the patient’s expired CO2 from the hood. “Then we were quickly requested to extend the benefits of the hood interface (which are the comfort for the patient, the ability to start the treatment very early and continue for many hours if needed) to the mechanical ventilator,” Finotti said. The question arose: Could the same concept be used for mechanical ventilation in Pressure Support or Bipap ventilation modes? While the basic concept was still applicable, it needed to be tweaked. So, once again working with physicians, they developed a new family of hoods, designed specifically for the purpose of mechanical ventilation. “We learned, step-by-step, that the volume has to be reduced, the compliance of the system has to be reduced, and many other inputs led us to design an optimized hood for ventilation,” Finotti said. The company's Research and Development Team continues to develop new helmet models and accessories to improve hoods that can be used for different medical situations. This includes hoods for CPAP and hoods for use on the mechanical ventilator, “openable” hoods, and hoods with no rigid ring... The challenge was which hood should be presented to the FDA for emergency use authorization. “We did choose the NIV hood for the very simple reason that it’s a smaller design, but if it has to be used for CPAP, when it’s compared to a normal face mask, still has all the benefits of the hood interface compared to masks,” Finotti said. StarMed NIV is somewhat of a multi-use helmet, depending on the need of the patient and the clinician. It has some specific differences. “We are very proud of the material used for the neck seal: we really believe this is one of the big differences between our product and the others,” Finotti said. The material is an extremely thin, plastic film that is not silicon, but exceptionally soft and elastic. It also has biocompatibility that is optimal and is a better material for the application for which it is used. The neck seal has been improved not only for the patients’ compliance but for safety. The hood has an inflatable neck cushion that improves the patient’s comfort and helps to stabilize the interface to achieve optimal mechanical performance. As a result, many clinical studies have proven the effectiveness and great performance of NIV hoods in different patient populations. Even before COVID-19 emerged, the company was working on different helmets and added some improvements that alone took a few months to complete. The flow diffusers were redesigned to generate less noise and improve flow dynamics, the access ports for feeding tubes and catheters were shaped for ensuring optimal seal on various lumen gauges. Two color-coded caps are provided for these accesses to cover all possible catheter options needed for patients of different sizes. “It’s an easy system to apply after you get used to it,” Savickaite said. “We’re going to go through the learning curve here, but with an early application to the patient – on the field, in the ER, on the wards – we can definitely increase the survival rate for these patients and prevent all the complications that may come with the delay of positive pressure ventilation.” Helmets can also be a huge benefit to immune-suppressed patients, she added. Savickaite credited the Italian physicians for their work and research. “I know that everybody is asking for more studies done in the US, but you can always look what the Italian physicians did, who spend so much time and have lots of experience with the helmet ventilation – and they are still using it, so that should be a good product, right?” “In today’s new world, where we are getting used to the new normal, I think the helmet is a great device to prevent the pathogens to spread out and prepare us for more pandemics. The helmet ventilation can actually stop that spread – or at least reduce it,” Savickaite said. About Intersurgical Complete Respiratory Systems: Intersurgical is a global designer, manufacturer, and supplier of a wide range of medical devices for respiratory support. “We provide flexible patient solutions for airway management, anesthesia, critical care, and oxygen & aerosol therapy for use within emergency care, hospitals, and in the home." Video You can send your inquiry directly to the manufacturer here Hands-On Review Video - NIV StarMed CaStar R Hood from Intersurgical Ltd

9/29/2020 Chicago This is a video review of the StarMed CaStar R Hood for Non-Invasive Ventilation made in Italy. The StarMed CaStar R Hood is FDA EUA Approved You can send your inquiry directly to the manufacturer here. More StarMed CaStar R Hood for NIV Product Info A list of studies done with StarMed helmets

09/25/2020 Chicago Now that helmet-based ventilation is becoming more accepted and available throughout the medical communities fighting COVID-19, one company, Charged Concepts, is working on developing accessories to further enhance the capabilities of helmet-based treatments. Charged Concepts, Inc., led by biomedical engineer and CEO Wayne Penn, is a global multidisciplinary research and design firm based in Nashua, New Hampshire. While its past projects range from phone charging systems to educational toys, the company’s main focus – and strength – lies in the medical field. Speakers: Wayne Penn, Charged Concepts; Aurika Savickaite, HelmetBasedVentilation.com; Evan Weinberg, Saigon South International School Educator; Travis Teague, Developer Growth Lead Helium Concepts. The Charged Concepts team features a diverse blend of engineers, physicians, nurses, industrial designers, and regulatory experts who collaborate to identify unmet challenges in the medical field, define their scopes, and develop innovative solutions. The team defines a truly “charged” concept as one that can be transformed into impactful programs, technologies, and initiatives. Since March, the Charged Concepts team has been developing important technologies that will complement and integrate with the helmet-based ventilation system, starting with a monitoring and alarm suite for the helmets. “Alarms play a very big role in a hospital, and are a very important part of the workflow,” said Aurika Savickaite, RN, MSN, and co-founder of HelmetBasedVentilation.com. In both ICU and non-ICU settings, medical teams rely on sensors, audible alarms, and visible alarms to manage and monitor patient care. In the busy environment of a hospital, nurses are mostly caring for more than one patient at a time. Alarms, triggered by sensors monitoring factors such as patient vitals, medication deliveries, and environmental conditions, keep medical personnel aware of the urgency of patient needs and enable faster responses to emergency situations. The monitoring and alarm suite under development by the Charged Concepts team will feature sensors to monitor flow rates, temperature, pressure, humidity, and carbon dioxide levels in the helmets, as well as calculate the fraction of inspired oxygen (FiO2) from air and oxygen mixing. Integrated software will trigger alarms when these conditions move outside of the intended ranges for treatment. Conveniently, the team’s monitoring and alarm suite can be added onto conventionally-available helmet-based ventilation systems without any physical modifications to the helmet. The team aims to create a streamlined tool that can quickly answer critical questions about treatment – What is the pressure inside the helmet? What is the oxygen concentration? Has carbon dioxide concentration reached a level that could be harmful to the patient? – giving the health provider team the information they need to monitor how the treatment is progressing and make better decisions for the patient. “We want to have the computers do the work of monitoring these factors during treatment, so the medical personnel can focus on the care of the patient,” said Charged Concepts team member and educator Evan Weinberg, who teaches engineering and technology at Saigon South International School in Vietnam. As part of his technology curriculum, Weinberg teaches high school students to code simple control systems to trigger lights or buzzers in response to changing conditions monitored by sensors. He hopes that, by securely streaming data from the monitoring and alarm suite to the phone of a nurse or doctor in real time, the Charged Concepts system will enable more efficient and appropriate care. “It’s something that will hopefully make things easier for [all treating COVID-19],” Weinberg said. “We’re looking to build these systems so they are robust and flexible enough to work both now and into the future, as well.” Travis Teague, Developer Growth Lead at Helium Systems, a provider of technologies related to low-power, long-range, encrypted communication between devices on the Internet of Things (IoT), said that their data technology system, “LoRaWAN”, allows for secure data transfer with a highly permeating radio signal for communication across very long distances. “Inside areas like hospitals, where it’s very "noisy" with signals being transferred to and from devices, a lot of times your Wi-Fi – 2.4, 5G – is not going to be as nearly as effective at transferring data as these sub-G bands [Helium’s radio signals], which allow you to have much better coverage [and] a lot better error correction,” Teague said. The technology uses a spread-spectrum-like chirp protocol, which allows users to work in very noisy environments and still have an exceptionally good end-to-end collection of the sensor data, Teague said. The encrypted data from the hospitals can be collected, scrubbed of patient-identifying information, and aggregated to allow others to learn from it. “The end goal is to increasing treatment response speed and efficacy while decreasing oxygen consumption rates and the consequent costs that go along with that,” Penn said, “if we can use [artificial intelligence] machine learning – or allow a nurse or doctor from the nurses’ station to remotely optimize and adjust a patient’s treatment protocol, without even having to go into the room – we can save the 30-60 seconds it would otherwise take for the caregiver to physically reach the patient and start that intervention. Every minute that we save buys the patient a greater chance of recovery and survival.” COVID-19 is an evolving problem, Weinberg said, and everyone needs to work together to get right. “We want to intervene as quickly as possible, [and] make the system intelligent, robust, and secure,” Penn said, “with the technology we’re developing, we can collect a pool of data for future researchers to perform retrospective studies – they can go back and see what worked and what didn’t work.” In addition to the monitoring and alarm suite, the Charged Concept team is developing a proning pillow accessory for the helmet-based ventilation systems. Proning pillows allow a patient receiving a helmet-based treatment to be moved into a prone position on their back or side, without removing the helmet. This positioning allows for improved lung expansion and enhanced expulsion of secretions, which can decrease pulmonary distress and improve breathing. “These accessories are extremely important for the helmet-based systems,” said Aurika Savickaite, RN, MSN, and co-founder of HelmetBasedVentilation.com. Though she acknowledged that her team is still waiting for studies to be finalized and published, she noted that Italian patient data collected early in the pandemic suggested that early proning of COVID-19 patients contributed to higher survival rates and fewer complications. In keeping with the team’s mission to identify and address unmet challenges, Penn emphasized that the accessories under development by the Charged Concepts team aim to “fill in the gaps” in helmet-based treatment protocols. He further stressed that the products are all “helmet-agnostic” and not specific to any one manufacturer’s helmet design. A universal line of products will increase adoption and make the helmet-based ventilation technology more accessible and cost-effective when it is needed most, he believes. The team is currently working to better understand the dorsal (back) lung region and how their proning pillows could allow patients to be positioned to better expel secretions and still be comfortable. They are developing a variety of proning pillow designs, including one that resembles a pair of earmuffs and one that can be inflated and deflated as necessary. They have even designed a pillow that could be moved with an external magnet to allow repositioning by the patient or medical team without removing the helmet. “All the technologies we are developing are designed to make the jobs of the nurses, doctors, and caretakers easier, allowing them to focus more on improving the patient’s care and comfort,” Penn said. “Ultimately, no matter what we do, no cost or amount of money made can replace the life of a loved one, so anything we can do to improve treatments and increase patient survival will be worth the effort,” Penn said. The team at Charged Concepts is pushing on with their development, emphasizing that they are resolved in knowing that the technologies that they are building now will lead to further adoption and advancements in non-invasive helmet based ventilation not only for COVID but for future infectious diseases, as well as have lasting impact in both first world and developing nations where infrastructure, resources, and personnel may be limited. Charged Concepts is currently seeking funding and additional strategic partners to translate the concept demonstrators into commercial products, perform clinical testing, obtain FDA Emergency Use Authorization, and manufacture in volume. Charged Concepts and Helium would like to acknowledge and thank the following organizations for their contributions to this project: Helmet Based Ventilation, SparkFun Electronics, ReSound Clinical and Regulatory Consulting, VFX Lab, Saigon South International School, Integron, Sgnl24, Cantina Films, Companies of Nassal, and NASA. If you would like more information or can help, please contact Charged Concepts at info@chargedconcepts.com Video

08/18/2020 Chicago NEW YORK -- As a child, Susan Houde-Walter was groomed to become an artist – until she found she would need to learn physics to make holograms. She fell in love with lasers and optical engineering – and ultimately became the CEO of LMD Power of Light Corp. (“LMD”), a laser manufacturer in Rochester, NY. LMD has become part of the growing community working together to fight COVID-19. Susan shared the story with the co-founder of the website www.HelmetBasedVentilation.com, Aurika Savickaite. With LMD based in New York, Susan could attest to the impact COVID-19 had in the state. “New York was in tough shape. Governor Cuomo got on the news and basically said, ‘any manufacturers, if you know how to help New York State, contact our office,’” Susan explained. “So we did, and that’s how we got involved.” The company did their research – starting with information, webinars and videos on www.HelmetBasedVentilation.com. Inspired by the community of clinicians and industry coming together, the company focused its deep engineering bench and manufacturing know-how on a patientcentric solution. The result is the “Vyatil,” (pronounced vital), a nonpowered oxygen tent. The process was educational, she said. Perusing the medical literature, they learned about characteristics that affected COVID-19 patients : COVID-19 patients fared particularly poorly on mechanical ventilators; Supplemental oxygen with gentler interventions (nonmechanical) may be more effective at returning people to health; Proning the patient during treatment -- taking the weight of the heart off the lungs -- seems to be beneficial in quicker recovery; Hospitalization can be weeks long before a patient is considered recovered; and If the viral load is reduced, thus reducing the chance of infection, the medical staff can be better protected amid constant exposure. “All of these points suggested that a nonpowered oxygen tent may help the patient recover and also help protect the medical staff from the pathogen,” Susan said. Savickaite said another point was that noninvasive ventilation and proning can be used early in the treatment, can provide better outcomes for the patients. The takeaway – and motivation – was if patients can be kept off mechanical ventilation, it was best for the patient and the medical staff. A lot of resources – i.e. hospital beds and mechanical ventilators -- also are saved by using noninvasive ventilation, the two women agreed. The effort was a departure from making lasers. “LMD is a laser company,” Susan said, “we had to start with a clean sheet of paper and build our design from the point of view of patient needs.” Since the patient might be in the Vyatil for an extended period of time, the company emphasized patient comfort and safety. The Vyatil features a soft tent and a zipper across the top. The zipper allows immediate access for suctioning or other medical interventions, and also allows the patient to open the tent if they get claustrophobic. It was also important that the patient could be comfortably proned for a long period of time. “We’re using materials that are considered by the FDA to be some of the safest available for medical use, because the patient might be in it for a long time,” Susan said. LMD does not use latex or even PVCs because they can contain phthalates and dioxins. “We took all these things to heart when we designed our version,” she said. The helmet is registered with the FDA as a Class 1 nonpowered oxygen tent, which means it can be used with hospital wall gas or an oxygen tank, she said. The tent features soft inflatable tent, the zipper, inlet port, outlet port, a hydration port to allow the seal to be held, but lets the patient drink, soft silicone neck seal, and adjustable arm straps. The port positions maximize the mixing of gas inside the tent and minimizing CO2 rebreathing. Also by keeping the ports away from the ears, the noise also is reduced for the patient. The tent also provides lots of room for the patient, along with great visibility for the patient and the medical staff. “You are the first ones in the US to develop a tent with a zipper,” Savickaite pointed out. The tent is put on the patient with the zipper open, fitted with a viral filter and PEEP valve, hooked up to the oxygen, and the air is turned on. Once zipped up, the tent is inflated in seconds. The patient, if able, can walk around while wearing the tent. Savickaite noted the tent is very lightweight, adding to the comfort for the patient. They also collapse flat for easy shipping and storage. Clinicians have commented favorably on the zipper and the quality of the neck seal. “We are delighted to get clinicians’ feedback,” Houde-Walter said. “We’re planning on a series of these, so any kind of feedback will be very valuable, especially if it is patient focused – that’s our primary interest.” LMD is selling the Vyatils – and have set up a special website with videos and downloadable materials, https://www.vyatil.com. Video Hands-On Review - VYATIL Oxygen Tent video

08/13/2020 Chicago People diagnosed with COVID-19 -- and the physicians treated them -- have just received another piece of arsenal to fight the virus – the FDA issued Emergency Use Authorization (EUA) for the "Subsalve" noninvasive ventilation helmet. “This is a huge achievement for Michael Lombardy, his team, and the whole helmet industry,” said Aurika Savickaite, cofounder of www.HelmetBasedVentilation.com. “The FDA gave a green light for all the physicians to use the helmet for the COVID patients for noninvasive ventilation in the ICU settings, which is great.” The helmets gained momentum with the onset of COVID-19 early this year, with countries like Italy leading the way and introducing the concept to hospitals, physicians, and manufacturers in the United States. With many advantages over invasive-type ventilation, the helmet gained great interest when able to be used in the right situations for patients fighting COVID-19. Savickaite and her husband, David Lukauskas, started the website with the intention to share information about the noninvasive helmets when the COVID-19 pandemic struck, sharing the stories of physicians throughout the world, helmet manufacturers, and studies regarding helmet use. Savickaite, MSN, RN, was involved in the successful trial of the helmet ventilator in the ICU at the University of Chicago during a three-year study. Advantages of the helmet include faster recovery time, shortening an ICU stay, less need to intubate, lower ICU mortality, minimal or no sedation, and less cost, due to faster recovery, less-invasive treatment, and lower-cost device. However, these advantages were not being optimized, because some were hesitant to use "off-label" the FDA approved helmet, Savickaite said. It was more difficult to gain administrative approval for helmets – and there were some facilities that would not use the devices." Now, with FDA EUA approval, the doors will open more easily, gaining faster approval from administrators, less paperwork, and a safer legal process for the treatment. With faster administrative approval, more clinicians will be able to access the helmets, and more patients can be treated. “Hospitals should feel comfortable using this device and save more lives,” Savickaite said. “I truly believe, this will help more COVID patients, and at the same time, physicians will notice how well (the helmet) works for respiratory distress. In the future helmet can be used for patients who don’t have COVID, but who require non-invasive ventilation,” Savickaite said. For more information on the FDA approval for each helmet, got to the "Buy" page.

08/07/2020 Chicago This is a video review of the VYATIL Nonpowered Oxygen Tent made by the LMD-Power of Light, NY. VYATIL Neck Size Guide: The VYATIL is FDA approved. You can order this helmet directly from the manufacturer here.

08/06/2020 WORCESTER, MASS -- Aurika Savickaite, co-founder of HelmetBasedVentilation.com refers to Rachel Carragher as a helmet “champion” and “pioneer.” Early in the battle to fight COVID-19, Carragher, a respiratory therapist at UMass Memorial Health Care, Worcester, Mass. started researching the use of the noninvasive helmet. The physicians began looking at helmets in March, and after talking with doctors in Italy about their use, one of the anesthesiologists who works in critical care medicine, Dr. Rebecca Bauer, ordered and purchased the helmets on her own. The helmets were delivered to Bauer in April, and she brought them to Carragher’s office. “And that’s how I ended up with the helmets,” Rachel said. “We all came together as a group to try to figure out the best way to utilize these helmets for the patients,” she said. At that time, there was not a lot of information about the helmets, so the medical staff worked together to develop the best practices. The BiPAP machine proved to be too loud, so they switched to the high-flow set-up for the nine patients they used the helmets on; the average age of the COVID-19 patients the helmets were used on was the mid-50s, Carragher said. The patients came up to the ICU from the emergency room. They were usually on high-flow and were switched to the helmet in the ICU. They kept the flow to 80-85 L/min, Carragher said, which proved to be the most effective and most comfortable for the patients. Higher flows would prevent any fogginess, she added. The team started to network with other physicians in Chicago and at UMass hospital. Carragher’s medical director, Christine L. Bielick Kotkowski, who specializes in pulmonary disease, and Dr. Bauer were among those who were rallying for helmet use. “They were true supporters of the helmet with me and helped me on a physician level to get buy-in from the physicians,” Carragher said. One of the trial patients was a 56-year-old male in severe distress – and it was his initial success that impressed many of the doctors and nurses. “When we put (the helmet) on … he turned the corner so quickly, he was actually sitting in a chair, facetiming his family, he was doing extremely well with the helmet,” Carragher said. “We got a lot of buy-in from the nurses because they actually saw how well he improved, so that was great that the nurses in the ICU, actually witnessed how well this individual turned around,” she said. Not all patients are candidates for the helmet, as some can’t tolerate the hood. The patients in the trial averaged about three to four days, and some did need to be intubated, as well, Carragher said. The trial patients were not prone, Carragher said. “We wanted to, we just weren’t at that time, doing that,” she said. Some patients received low sedation to help their comfort level, she added. Letting patients get their nutrients also helps with comfort. The helmet requires work and is time-consuming in the beginning, and education is essential. Some of the early challenges including feeding patients and making sure the helmet was fit correctly. “You have to learn you have to go over those bumps before you start to feel very comfortable using the helmet,” Savickaite said, referring to the protocols shared on the HelmetBasedVentialation.com website. Medical personnel should also watch for pressure injuries around the arms and other areas, Carragher said. “And then just really be careful around the patient’s neck,” she said, adding they used a DuoDERM® dressing for a patient who used a helmet for a whole week. The dressing helps seal the helmet as well, and can be more comfortable, Savickaite added. With COVID cases currently down in her area, Carragher said they will be able to regroup and learn more about the helmet, and different ways the helmet can be used with patients who have respiratory needs. Carragher shared an important feature of the "Sea-Long" helmet. “There is an inspiratory side (with a one-way valve) and an expiratory side,” she said. “That’s really important to know.” Patient education is important, and is an ongoing process, Savickaite said. In conclusion, Carragher said that it is important to have a helmet “champion” on the team. “You need a ‘superuser’; you need someone who is passionate and is willing to try new things,” Carragher said, suggesting someone in the anesthesiology department. “You need someone very clinically strong and who is willing to devote time to put something in place and then be able to educate your nursing staff, your physician staff, your respiratory therapists." “It’s lots of work, but hopefully the outcome is that these patients aren’t getting intubated,” Carragher said. Video -

07/14/2020 A “mom and pop” medical systems manufacturer – once manufacturing 60 to 100 helmet ventilators a week, now is seeing orders go off the charts since the onset of the COVID-19 pandemic. The owners estimate the company now manufactures 1,000 per day, all of which go through quality checks. Chris Austin, who leads the family-owned Sea-Long Medical Systems, Inc. in Texas, describes the journey as a “Cinderella” story. Once the shoe fit, so to speak, life as Sea-Long knew it entered a whole new realm. He and some of his leadership team shared the story with Aurika Savickaite, co-founder of the helmet-based ventilation website, www.HelmetBasedVentilation.com. It all began a few months ago, when Wall Street Journal reporter called and asked to do a story on the company’s efforts to manufacture the noninvasive helmet ventilators. “Within 24 hours or less – we had calls from NBC, CBS, overseas newspapers, TV stations, New York Times … I mean I could just go on and on,” Chris Austin said. “It was just so overwhelming to see that kind of response.” Within two days, Sea-Long’s phones were ringing off the hook in the shop behind their home in Waxahachie, Texas. “Every time you went to go take a phone call, you couldn’t even pick the phone call up without it ringing,” Austin said. That pace continued for weeks – and it was both exciting and frustrating. It was troubling, Austin said, because the company felt they were missing many calls and email inquiries – and it was frustrating some customers. That said, they were working at the shop for 18 to 20 hours a day, filling the thousands of orders they did get. “It was an interesting time, but it was critical to allow us to expand and grow the way we did so fast and partially due to the caliber of people who believed in the product – but more importantly maybe, believed in the technology to save lives, and that’s what we’re all about,” Austin said. “There was no way we could turn away anybody, “he said. “We always tried to put ourselves in their shoes – or their shoes in watching their grandmother or grandfather or son or daughter for that matter in that hospital bed.” As word continued to spread, so did the offers to help with the cause. Several companies – including Virgin Galactic -- contacted Sea-Long to expand to the manufacturing facility with state-of-the-art equipment to keep up with the current demand – something that would normally take years instead of a few months. The demand brought out a vast variety of workers from miles away – including volunteers who would sleep in their vehicles to help put out the orders. Chris Austin talked about tweaks to the Sea-Long helmet to enhance the seal design, and also improvements in the training materials. The company also developed kits which contain all materials needed for hospitals to implement the helmets. “Any great medical growth comes from situations like this,” said Dr. Laura Austin of Sea-Long, referring to the pandemic “We knew there was a benefit and an opportunity to be using this hood for noninvasive ventilation,” Laura Austin said. “Anybody who has had any work in the medical realm could say what a benefit that is if you don’t have to intubate a patient, or trach a patient, and how much quicker they’re going to better, the amount of comorbidity is not going to be there afterwards – all (those) negative side effects. “But you have to get doctors and hospitals on board to do the research, we can’t physically do the research, we have to have those partnerships to help take this product and then say ‘Hey, this is what is really can do,’” she said. Research needs to continue, Dr. Laura added. “We need multiple studies to continue to further this in order to really show this is a huge benefit, and at very low cost, very low, negative side effects afterward, and overall a much quicker healing time.” That helps decrease the cost of care, another benefit, Dr. Laura said. “Best evidence, best care for the patients, as low cost as possible,” she said. The feedback from clinicians was crucial to the company’s focus – knowing they were working the greater good. The Sea-Long team knew they were contributing to saving lives – even while fighting the red-tape bureaucracy of the hospitals to hasten implementing the technology. “We had quite a few doctors buying (the helmets) themselves out of their own money to get the products shipped to them right away to their homes, because they couldn’t go through channels because they knew it would take weeks and weeks … and they would tell us .. if I don’t get this to them by day after tomorrow, they will be dead, I know they will be dead,” Chris Austin said. Sea-Long decided then and there to incorporate overnight shipping to accommodate the need – even at some financial loss. Austin shared a story how they rushed a helmet out to a doctor who was in tears because she was afraid she would lose a patient. Sea-Long rushed out a helmet – and within 24 hours the doctor called, again in tears, but this time to say the patient’s condition immensely improved in just a few hours. “At the end of the day, we can really feel good about what we were doing, because people’s lives were saved,” Dr. Laura said. Currently, the helmets are being sold within the United States, and also outside of the US, including South America, South Africa, and Indonesia. Sea -Long has discussed ways to help manufacture helmets in other countries, as well. The simplicity and low-cost of the helmets make it an excellent option for many, Aurika added. The benefits of noninvasive ventilation are evident in not only the benefits patients receive – but in the high risks they avoid, said Dr. Duke Eason, including pneumonia, vocal cord damage, tracheostomies -- even death from the efforts to save their life. “(This helmet) is simple, it’s direct, it’s easy to understand the physics and physiology, and it really has made a big difference,” Eason said. “I can’t say that I’m aware of any specific bias against European-based research.” The numbers are there to back up those challenges, he said. Despite the fact the helmet was widely used in European countries, until the media – and the pandemic – brought attention to the helmet, its benefits were almost a secret, he said. The simple, noninvasive helmet continues to be another step in fighting COVID-19, and a real chance to avoid intubation, Savickaite said. As areas are starting to experience another wave of COVID-19, this is not the time to stand by. “Now we know that some states are experiencing a huge rise in COVID cases – some are taking a ‘break’ – but still, all clinicians who are not having COVID patients, I think it’s a good time to learn the system,” Savickaite said. “We know, COVID patients will not disappear this year, we know there will be another flu season. “Now it good timing, actually, to prepare for that next peak that is going to hit your country, your state, or your hospital,” Savickaite said, encouraging medical clinicians, and respiratory therapists to read all the research, and test the product while learning. It’s the time to be proactive, all agreed, to improve the quality of the hood, and also consider the respiratory uses of the helmet post-COVID-19. Video Instruction video for Sea-Lond Helmet setup

July 2, 2020, | Chicago | Infographics #5 by HelmetBasedVentilation.com Source: Patel, B. K., Wolfe, K. S., Pohlman, A. S., Hall, J. B., & Kress, J. P. (2016). Effect of Noninvasive Ventilation Delivered by Helmet vs Face Mask on the Rate of Endotracheal Intubation in Patients With Acute Respiratory Distress Syndrome: A Randomized Clinical Trial. JAMA, 315(22), 2435–2441. https://doi.org/10.1001/jama.2016.6338 Kyeremanteng, K., Gagnon, L. P., Robidoux, R., Thavorn, K., Chaudhuri, D., Kobewka, D., & Kress, J. P. (2018). Cost Analysis of Noninvasive Helmet Ventilation Compared with Use of Noninvasive Face Mask in ARDS. Canadian respiratory journal, 2018, 6518572. https://doi.org/10.1155/2018/6518572 Norris, C., Jacobs, P., Rapoport, J., & Hamilton, S. (1995). ICU and non-ICU cost per day. Canadian journal of anaesthesia = Journal canadien d'anesthesie, 42(3), 192–196. https://doi.org/10.1007/BF03010674

Dr. Yasser Khan recently shared his experience in developing a portable CPAP/BiPAP machine to be used with COVID patients with HelmetBasedVentilaton.com co-founder Aurika Savickaite. Khan, born in Bangladesh, came to the United States for his undergrad and went to Saudi Arabi for his masters. The project began when he saw the dire need for ventilation for patients in poorer countries like Bangladesh. “It’s actually quite challenging in Bangladesh,” he said. “We didn’t expect the cases to surge as much – and now it’s surging really fast.” The lack of accessibility to treatment is even more challenging for COVID patients. Doctors are overworked, as well. He reached out to many friends to help with the project – from financials, logistics, or technical needs. “Every email I sent, I got a ‘yes’ response back,” he said. “This is a community effort … it’s not just me, … it’s everyone, whenever we asked for help.” In the beginning, the men found that intubation with patients in these countries would be difficult because there were not enough ICUs combined with a lack of trained medical personnel. “That’s why we started focusing on non-invasive ventilation,” Khan said. It was essentially a volunteer project, Khan said, utilizing the help of students, and researchers in the Bay area. Engineers from Bangladesh and working at Stanford and Berkeley soon joined the project, Khan said. “We started looking into how can we create a low-cost solution that can be deployed in a country where we don’t have enough medical resources,” Khan said. That led to work on the CPAP/BiPAP machine, which does not need a compressed air source. With an invasive ventilator, an air source which is high pressure/high flow is needed from the wall -- available from developed countries – but much less available in underdeveloped countries. “With CPAP/BiPAP, you use a blower, so essentially you have the source within the unit, so that is one of the biggest benefits of having this solution,” Khan said. “Another thing is we needed to make something which is low-cost, portable, and easy-to-use,” Khan said. “These are extremely important factors because if it’s expensive, we cannot afford it. If it’s hard to use, we cannot give it to doctors to train.” Portability was important in order to get the unit in as many hospitals as possible. Working around the clock for several weeks, the team worked to meet those criteria, testing out different blowers and motors, and within six weeks, developed a small unit which met all the needs. The self-contained unit – easily held in one hand, includes a blower and compressor and has a touch screen display to provide easy set-up and use. The challenge was making the unit useful for COVID patients without contaminating the unit. “At that time, on your website, we found that helmet-based ventilation is a good option,” Khan said, explaining the aerosolization of the virus is contained. Once this option was explained to leery physicians, the doctors changed their mind. “Then they became super excited -- they started telling us ‘we need this immediately’,” Khan said. Khan described the progress as the end of phase one, with test units now in Bangladesh. “We have a medical team over there (and) they are going to test the units,” he said. “Once we have feedback from them, then we will plan the next step.” Khan said communication with the patient is important, to keep them calm and informed. He also found the ease of getting the helmet on and off, and the access ports make it easy to keep the treatment interrupted, as well. Aurika described the compact machine as life-saving – stating how the unit can deliver the flow at a max rate of 180 liters per minute – something usually only seen in large facilities. The units are now in a 2,600-bed teaching/research hospital in Bangladesh. COVID patients follow a protocol and that research will be used to fine-tune the design. Currently, the unit costs about $200 per unit made in the small research lab – but Khan hopes with high-volume production will lower that cost, in addition to more cost-reducing strategies. Alarms also alert medical staff to disconnects, a plus for the staff working with the patients. “Hopefully, once the design is validated by the doctors, one of the manufacturers can take the design and start making this in bulk,” Khan said. “That will actually reduce the cost. That’s our plan.” Kahn also is looking for feedback from patients and physicians to help improve the machine. Once the unit is validated and specs are confirmed, the design will be open to be shared with others, Khan said. There also are plans to have the unit FDA-approved, he said. FDA-approved devices can often get faster approval in other countries. “This is an all hands-on-deck project,” Khan said. “Everyone is chipping in on this. It’s not just Bangladesh. Once we go through the whole thing, we can share our story, share our design. The other countries can also pick that up.” “That will help all the countries, not just Bangladesh.” The challenges are felt around the world, Khan said. “It’s quite daunting for the whole country (Bangladesh),’ he said. “The government is trying,” Khan said. “The problem is the whole world is suffering. “Since the whole world is suffering, it’s hard to mobilize help from other countries to help countries in need. It’s a huge challenge, I think it’s the biggest challenge of our lifetime.” Video More videos from Dr. Yasser Khan

6/25/2020 Chicago Michael Lombardi of Lombardi Undersea LLC shares his expertise on Subsalve helmet - oxygen-hood NIV respiratory circuits and how to access some safety features through off-the-shelf components. The Respironics piece is a spring-loaded, one-way directional valve. When the flow fails, it leaves three ports on the side open (~2cmH2O). This still needs to be tested to determine how much fresh gas can be drawn through that port. This setup can be an effective and easy way for any helmet to allow the hood to open instead of close in case of an emergency. Pressure relief setup: To reduce COVID19 virus aerosolization, you must use viral filters with the helmet. Unfortunately, filters can clog easily with condensate. This following setup will provide a pressure relief feature and prevent the filter from clogging. First, the standard respiratory limp should point up; this will keep fluids from running down into the filter. You still have your PEEP valve to control pressure; you will need to add a second PEEP valve and point it down low. Set the second PEEP valve on higher pressure than the primary PEEP. If the filter connected to the primary PEEP valve gets clogged, then the secondary PEEP valve will kick in and act as an overpressure valve. As an example: The primary PEEP is set at 10 centimeters and the secondary PEEP is set at 12 or 15 centimeters. The secondary PEEP acts as the overpressure valve while also reducing any significant pressure increase. Thanks to multiple teams, including Subsalve, helmet developers are continuing work to fight the pandemic, including delivering kits to underdeveloped countries. Countries like Nigeria, the Philippines, and a few places in Central America have approved helmet-based ventilation and will use it for patients in respiratory distress. Video Click here to learn more about Michael Lombardi

6/3/2020 Like many people and businesses worldwide, Fernando Herreros' event planning business was closed due to COVID-19. “So, we had to find a new way to make money,” said Fernando, who lives in Asunción, Paraguay. Fernando shared the story of how his quest to make up lost income led him to support the effort to help patients with COVID-19 with Aurika Savickaite, co-founder of the www.HelmetBasedVentilation.com website. The businessman – who had no connection with the medical field -- started to look around for inspiration as the world around him closed down and found isolation pods were being used to transport patients with COVID-19. They went back to their factory and manufactured a pod. Medical personnel started asking if they could make products – and eventually were contacted by a physician who asked if they could make a helmet. Fernando’s team got to work – and, working with physicians, came up with a helmet. Once the prototype was complete, Fernando’s team started reaching out to physicians to have them try the design. Utilizing information found on the www.HelmetBasedVentilation.com, the team was able to demonstrate for physicians the different ways the helmets could be used – from wall oxygen to high-flow machines. “It worked perfectly every time,” Fernando said. With little to no helmet awareness in Paraguay, the concept was welcomed with open arms to fight COVID. “We’re like the pioneers in this [the Helmet NIV],” Fernando said. “The doctors are very happy with this and need it for COVID right now, to protect them more than the patients.” The one-piece helmet is made entirely out of PVC, with all SDS certifications, with ports for patient access, expiration, inhalation ports, and the neck seal and arm straps are silicone-based. The helmets also can be cleaned for use with another patient, and the neck seals can be replaced if needed. The flexible neck seal can be somewhat adjusted to adapt to different sizes. In demonstrating the helmet, Fernando was able to put the helmet on within seconds. The positive pressure inside the helmet, the negative pressure outside, and the silicone neck seal combine to make a good, leak-free seal. The flexible PVC allows patients to lie down, as well. “[Nurses] told us one of the major benefits was getting the seal right,” Fernando said. “When you put the helmet on, the seal in the neck just sticks to your neck.” Fernando’s team found having the straps adjusted correctly also is very important, as there are no leaks when they are pulled tight. One “inconvenience” is it is difficult to hear when wearing the helmet, and medical personnel might have to speak a bit louder when talking to the patient. “That’s it, that’s the only thing we found negative,” Fernando said. Unlike the helmets, many more adjustments are needed with a face mask to find the perfect fit and seal to avoid leaks – and those adjustments can sometimes take 20 minutes – crucial minutes. In one clinical trial, a patient had a low saturation of oxygen, Fernando said. “After 10 to 20 minutes of using a helmet, the saturation got a lot better – in 20 minutes' time,” he said. “And that was how long it took to put the mask on before.” Patients often relax more when using the helmet, allowing them to rest easier and help in recovery. There are not many doctors in the small country of Paraguay, so the impact of COVID can be even more devastating. “If we get to the time where our doctors start to get ill, it’s going to be very bad for us,” he said. “So, we started working on this and we’re hoping to help the most people we can.” So far, 10 helmets have been made and given away to hospitals to try. (Country) is poor, medical care scare, and there are very few ventilators available. A pediatric helmet is in the works – in an infant/toddler and older child model. Intubation is extremely hard on adults – even more so on children, with long-lasting effects. Dubbing the helmet as an “astronaut” helmet, youngers are more receptive, and the process is much easier on them than adjusting a mask. Avoiding unnecessary intubation is a major plus. “I think that’s going to be the first thing we are going to deliver because they really need it there,” Fernando said. Savickaite agreed the need is there.“It’s so sad when you see those little kids being on a ventilator,” Savickaite said. Overall, the availability of helmets in Paraguay and other countries will be a great benefit to medical personnel and patients. “We know that the helmet is going to very helpful there,” Fernando said, adding that a helmet was used in an ambulance and it worked. “Everybody is afraid of COVID right now,” he said. “So, it [the helmet] would be great protection for everybody. And imagine just like taking the patient with the helmet on from the ambulance to the hospital; everything is quicker.” And being able to avoid intubation, if possible, is a great benefit, Savickaite added. Now is a good time to introduce the helmets, Savickaite said, adding cases are low right now. “Right now, we have just 10 people in hospitals, and 1,000 cases,” Fernando said. But they are preparing. “Brazil has a lot of cases; it’s just a matter of time,” Fernando said. Flu season is on its way, so it could be even more of a struggle. The physicians are receptive to using the helmets and are trying different types of configurations to see how it works. “We’re getting a lot of help from the physicians here, we’re very happy about that they want to use the helmet,” Fernando said. “We just need to get the final certification to be able to get it out there, but we have everything perfect.” Savickaite agreed, saying FDA approvals tend to take a while. Fernando estimates production at about 100 per week, with the potential to upscale those numbers. The website, www.HelmetBasedVentilation.com was very helpful in the development of their helmet, Fernando said. “We got a lot of information from your website, and watching the videos and reading the studies,” Fernando said. The global effort to develop helmets to combat COVId-19 is appreciated by all involved. “It’s a huge thing to get help from people who don’t even know you,” Fernando said. “We just want to help – we know it’s going to help a lot of people,” Fernando said. “Especially the doctors, the nurses – and everybody that works in health care.” It’s a win-win for all, according to Fernando and Savickaite. “They’re scared to go to work, so we think if we put a helmet on the patient, it’s going to be a little bit less scary and the therapy is going to work on the patient,” Fernando said.