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4/19/2020 Chicago As COVID-19 cases are rising, so is new information about what is best for patients and medical staff. But with short supplies and increasing patient demand, the urgency and effectiveness of non-invasive ventilation (NIV) is more apparent than ever before. Companies have been stepping up to the task of providing ventilation equipment to hospitals in need. Formula One engine manufacturer Mercedes developed Continuous Positive Airway Pressure (CPAP) face masks to treat patients with respiratory complications as a result of the virus. And Tesla CEO, Elon Musk, donated bilevel positive airway pressure (BiPAP) and CPAP machines to several California hospitals. Musk has been outspoken on Twitter, using his platform to share advice from doctors working on the frontlines of COVID-19. He is ahead of many of his counterparts. He is listening to the latest expert feedback - intubation is not the best option for COVID-19 patients. Musk’s approach is on the right track with delivering these machines and acknowledging the importance of another option before intubation. However, a better alternative for Tesla to produce is non-invasive ventilation via the "bubble helmet". Why are non-invasive ventilation helmets better? Prematurely jumping to invasive mechanical ventilation has done more harm than good for patients. The reality is that it hasn’t saved many lives. The mortality rate for COVID patients on the ventilator is 66% - as opposed to 19% for those that used non-invasive ventilation (data from the UK). Its operational procedure is extremely painful and invasive. As a result, patients need to be sedated. However, sedation drugs are in short supply. Medical providers under strain are more exposed to the virus and need to follow through with intensive, lengthy protocols. And it may cause more risk to patients with already compromised lungs. A non-invasive ventilation helmet solves these problems. It’s a win-win solution. The time to take the next vital step is now - advice and data from around the world are evident. Helmet based ventilation is being used widely in Europe with sizeable, real results. Countries like Italy, Germany, and France are seeing patients with high success rates of recovery, fewer days in the ICU and reduced need for intubation. In fact, the use of a helmet avoided intubation in 54% of patients with ARDS (acute respiratory distress syndrome). Heavily impacted Italy is already seeing 20-30% of COVID-19 patients avoiding intubations. It’s clear. Using the "bubble helmet" is the most optimal way to help patients with COVID-19, while freeing up more ICU space for those illest. They cost less, shorten hospital stays and lower the mortality rate, according to a study featured in JAMA, 2016. They’re not only more comfortable for the patient, but provide a stronger barrier against cross-contamination with an antiviral filter. Rather than using a mechanical ventilator, patients using the helmet connected to oxygen and airflow. Even Pulmonoligists advise against non-invasive positive pressure ventilation face masks due to the higher risk for aerosolization of the virus. The last thing we need in the midst of this pandemic is higher rates of infection. Face masks have been the norm, but we need to do better than the norm. In the race against time to save lives, the saving grace will be non-invasive ventilation helmets. Infographic More Infographics

4/16/2020 Chicago Here is a video review of the Oxygen Hood "Buble Helmet" made by Mr. Michael Lombardi in partnership with the Subsalve USA. From what we've seen so far it seems to be a very high-quality helmet. A video by the manufacturer "Lombardi and Subsalve USA team up to take on the Covid-19 fight with the development and production of an oxygen treatment hood for noninvasive positive pressure ventilation (NIPPV). This technology is very, very new in the US though has been used successfully in Italy for decades. Hooded NIPPV has proven to reduce required intubations by 20-40% according to studies at the University of Chicago." More Training video, guidelines & FAQ for the SUBSALVE oxygen treatment hood. An interview with the designer of this helmet Michael Lombardi "A gift from the sea" US diving experts designed an NIV Helmet "Oxygen Hood" for COVID patients You can order this helmet directly from the manufacturer here. "Subsalve" Oxygen Treatment Hood Gains FDA Emergency Use Authorization More about SUBSALVE Video review of all 5 NIV helmets that are made in the USA (as of 5/19/2020)

4/15/2020 Chicago A physician familiar with the helmet-based ventilation system is an advocate for their use in treating COVID-19 in the United States. Dr. Maurizio Franco Cereda of the Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center has a history with the use of the helmets. His credentials include Associate Professor of Anesthesiology and Critical Care at the Hospital of the University of Pennsylvania, among others. Cereda also practiced in Monza, near Milan prior to coming to the United States in 1999. Cereda said helmet-based ventilation has been used in Italy since before 1990, where it has since gained considerable popularity – and success. The same could not be said when the concept was first suggested in the United States. “Every time I talked about the helmet in the U.S., they always looked at me as a weird animal,” he said with a gentle laugh. Cereda considered doing different studies but didn’t have the support needed. With the “arrival” of COVID-19, Cereda discussed the prospect with his partners – and this time was met with more enthusiasm. Now, Cereda is introducing the helmets slowly throughout his hospital to ensure the process is being done correctly. “I think they averted intubation in at least three patients who are fine now,” Cereda said in an interview with Aurika Savickaite, cofounder of the Helmet-Based Ventilation website. Cereda and his staff are training other medical staff, he said. “The goal is to be able to deploy a massive amount of helmets as they do in Italy,” Cereda said. During its recent COVID-19 outbreak, the Monza hospital Cereda was affiliated with experienced notable success with the helmets. About 200 patients were simultaneously treated via helmet-based ventilation, compared to 50 to 60 intubated patients. “I am very familiar with (the helmet) and the system here has to get used to it,” Cereda said. “It’s new; people feel uncomfortable seeing something that is so different.” But as soon as the results are realized, those involved – from patients to physicians – are more receptive. “Everybody’s happy,” Cereda said. “I think it’s going to go well here.” Savickaite agreed. Invasion ventilation and intubation were the common treatment, she said but cited the high mortality rate usually associated with that method. “This is why I was thinking non-invasive ventilation is the answer right now,” Savickaite said. “If we can keep these patients oxygenated for a longer time on a helmet, we may see 20, 30 percent of patients on the helmet may avoid intubation. “That’s a pretty good number,” she said. Another goal is to have a CPAP-advanced respiratory care floor, caring for patients too sick to be on a regular floor, but whose care can be managed by other non-invasive methods, including the helmet, Cereda said. “That’s a great plan,” Savickaite said. “You need those helmet champions in your hospital that can deliver success.” Those successes are fueled by other attributes of the helmet-based ventilation system. “People feel safer not using high (oxygen) flows, and the helmet is a blessing for them,” he said. The method also affords protection for staff, as the helmets are self-contained, and can protect the staff from any respiratory spread. My goal is to have a system that can be used without any device or machine,” he said. “I want it to be as simple as possible.” Helmet use can also be used in crucial times when a patient is waiting for a ventilator – when the minutes – or hours – without any respiratory treatment could be a death sentence, Cereda said. “You want to have a way to bridge your patients, even if you know you’re going to have to intubate, you may not be able to intubate when you want to intubate – just because you don’t have an ICU bed, you don’t have a ventilator,” he said. “So instead of letting them die, while waiting, put them on the helmet, (and) you buy six, seven hours.” Savickaite agreed, citing her previous experience as a patient care manager in the MICU at the University of Chicago Hospital. “I see the big picture … these patients have to wait sometimes for the ICU room to get open and get that ventilator,” she said. Respiratory therapists – and patients – like the idea of the helmet, he said, referring to feedback after a demonstration at his hospital. “It was instant,” he said. “They saw the patient wasn’t choking himself and was happy, and the therapists were very happy.” There also is a degree of comfort for the medical staff – especially respiratory therapists, who are at the highest risk of contact, touching the patient, the ventilator and doing the suctioning. “The therapists know they are the most exposed people in the chain,” Cereda said. The self-enclosed helmet protects staff from contact. “I think it’s psychological; they feel they are protected,” Cereda said. “(When they see) someone cares about them, their mood is different. “I believe the way you show leadership is by showing that you care and that you care about your troops because this is like war,” he said. “So, if the troops know that the captain cares about them it’s a totally different mood in the unit. “And I think the helmets have been helping,” he said. In this mass scale disaster situation, the helmet can be a lifesaver – and it is hoped it can continue to make an impact post-COVID-19. As the need continues, so does the tweaking of the helmet – including a soft collar to not only make it more comfortable – but to increase production capabilities. “We’re putting a foot in the door … the hospitals and clinicians will be asking for it, when they see the benefit of it,” Savickaite said. “You will need less money, you can produce it faster, you can deliver it faster… this simple device.” Video - Non-Invasive CPAP by Helmet Setup COVID-19 | Maurizio Franco Cereda, MD About Maurizio Franco Cereda, MD: Associate Professor of Anesthesiology and Critical Care at the Hospital of the University of Pennsylvania Attending Anesthesiologist, Hospital of the University of Pennsylvania and Penn Presbyterian Medical Center Co-Director, Surgical Intensive Care Unit Program Director, Adult Critical Care Medicine Fellowship Department: Anesthesiology and Critical Care

4/12/2020 NOTE: This video is outdated and New Guidelines from Penn Medicine are available on the AmbiFi Smart Procedure app (05/25/2020) Maurizio France Cereda, MD, a University of Pennsylvania intensive-care doctor who trained in Italy where helmet use is common, shared this video for medical professionals today. Objectives Assembling the Helmet Circuit Setting up Gas Delivery for ICUs (Venturi) Initiating Therapy for ICUs (Venturi) Initiating Therapy for the Floor (Venturi Valve) Fixing the Helmet with Arm Straps Titration Guidelines Non-Invasive CPAP by Helmet Setup for COVID-19 WARNING Please always maintain total gas flow above 50 L/min at all times to avoid CO2 rebreathing. These helmets are designed for hyperbaric O2 delivery. They do not include a relief valve; undetected loss of gas supply can result in asphyxiation. Patients who are not alert and collaborative need to be closely monitored. Consider intubation if the patient is agitated. PDF guide

4/12/2020 Chicago A company based in Middleton, R.I. is making big strides to beat COVID-19 by manufacturing helmet-based ventilation units – with production and shipping expected after the Easter weekend. “I’m thrilled this type of treatment is finally being considered seriously in the United States,” Michael Lombardi of Lombardi Undersea LLC., said about the systems. Lombardi is a diving consultant, undersea specialist, and diving technologist specializing in cross-bridging tools and techniques from both scientific and industry sectors for creative underwater problem solving. He is the proprietor of Lombardi Undersea LLC., a 20-year-old enterprising undersea consultancy and support service, providing solutions for the routinely simple to extremely complex problems that often require technical human intervention. Lombardi in partnership with Subsalve USA has been developing a prototype of the helmet-based ventilation system which will be capable of mass production in a short time. The company shipped a small number of prototypes to several physicians throughout the country – including Mt. Sinai Hospital in New York City. "I am a diver/diving technologist by trade, so I knew of the hoods very generally as they are used in hyperbaric medicine. I didn’t connect that with COVID response until about 2-3 weeks ago. We move quickly!" Said, Michael Lombardi The prototypes also were sent to respiratory care groups in several Rhode Island hospitals. Lombardi also said the Rhode Island State Department of Health toured Lombardi’s manufacturing facility. The helmets have not yet been tried on patients, but physicians are pleased with the design, Lombardi said (on 4/10). They’ve been happy with the port positions and feel of the material,” In some ways, I’ve then been working on oxygen hoods for almost a decade! Lombardi said. “My understanding is they’ll be running some sort of controlled study for non-invasive dare’s this weekend – so we’re expecting to see it put to work before the next couple days,” Lombardi said in an interview with Aurika Savickaite, and David Lukauskas, founders of www.HelmetBasedVentilation.com. Lombardi is already taking orders. “Actually, we took our first significant order (April 9) through the Rhode Island Emergency Management Agency for 1,000 units,” Lombardi said. The units will be used in the state’s largest hospitals, including Rhode Island Hospital and The Miriam Hospital. Lombardi also sees the helmets being used in locations – like convention centers – being repurposed as hospitals during the COVID-19 crisis. Using supplemental oxygen with the hoods will help make the helmets field-usable, as well, he said. The challenge is streamlining the design for mass production, Lombardi said. “In our case, we work with materials that are all (radiofrequency) welded,” he said. “We have large format machinery that cuts patterns – precision cut patterns – so every unit is identical.” This format provides a couple of advantages, Lombardi said. There is no risk of leaking of the component isn’t fitted properly to the ring, and the helmet is made from a soft, flexible material. “You can recline back, rest your head on a pillow, or on a bed, and there are no rigid parts digging into your neck,” he said. The size – about 12”X12” – is comparable to other helmets – and the optically clear material provides a clear field of view for the patient, Lombardi said. The helmet using the same connectors to make them universally, FDA approved fits for ventilation hoses. The prototype also includes a couple of added features. “The inlet and outlet extend up into the helmet about an inch, the thought process being so if there is any cooling of condensate or phlegm or whatever inside the helmet, it’s not going to make its way back into the hood,” Lombardi said. “So, we’re pretty excited about that feature. The one-piece design means less chance of any pieces to get disconnected and scalable features for mass production are important features, as well, Savickaite added. The pre-production design has been finalized, and Lombardi expects to be able to manufacture 200 units per day within the coming week – and has enough materials on hand to produce 10,000 units. “Generally, we’re pretty excited, given the type of equipment that we’ve done in the past, this is actually a pretty simple product,” Lombardi said. “We have extremely high confidence that we can deliver.” Lombardi voiced a bit of caution regarding what he expects to be a “I want, nationally, people to realize is that nothing happens overnight, so, while yes, we can build 10,000 units, and we’re ramping up hopefully be able to do 1,000 units a day … there’s still a ramp-up period,” he said. “We’re not just dependent on our production capabilities but also our supply chains,” he said, noting business closures may present some limitations. The company is researching other material sources, he said. “I don’t foresee a major shortage in the near term,” Lombardi said. “But I have to have realistic expectations, that if places are anticipating putting this treatment to work within the next month …. We need orders – like serious commitment orders today.” The company already is making – and filling orders – which Lombardi expects to be sent within the next week or two. As the company works to fill orders, Lombardi said they are getting feedback from physicians at ways to improve upon the design, including adding a larger access port that could be used for oral medications. The plan is to first focus on distribution in the United States but may work with countries overseas who could help produce and/or distribute similar products, Lombardi said. The goal – and challenge – is to reduce as much shipping contact as possible, Lombardi said. Lombardi said there might be some cosmetic adjustments as the process continues, but nothing that would affect the ultimate result – saving lives. Hospitals can place their orders here. More about Michael Lombardi and how the helmet was ready to ship so quickly From Michael Lombardi: I’ve been among the very few leading the pack for what we call ‘technical diving’ within the scientific community. This involves using novel technology and techniques to permit deeper diving to advance scientific investigations. We’ve been at it since 2002 with work supporting federal agencies, various universities, and private firms. In 2010 and 2012 I was funded by the National Geographic Society to carry out a series of highly experimental deep dives (to 130 meters depth). We did lots of great work – discovered a new species of fish which is archived at the American Museum of Natural History in NYC, collected and provided novel biologics for natural product discovery which includes a potent anti-leukemia extract, and other natural history documentation. Most importantly was realizing the practical physiological limits for people to dive wet and subject to pressure (not protected by a submarine), and similar technological limitations. To remedy that, we prototyped a portable inflatable habitat – basically an underwater tent. The purpose of the tent was to provide an underwater refuge for the divers where they could be ‘dry’ while decompressing for lengthy periods of time at the end of a deep dive. This dry space is far more relaxing than hanging on an anchor line – we can eat, sleep, read a book, and so on. We deployed this experimentally in 2012 in the Bahamas, then again in 2015 in Hong Kong. Development continued in the field of life systems engineering such that we could maintain the inflated space’s atmosphere for human occupancy. I patented the technology in 2018 in partnership with New York University’s College of Nursing. My colleague on the patent, Win Burleson, was at MIT and his PhD advisor was Ted Selker. So through casual discussions, my colleague learned that the Selker’s were looking for companies to ramp up. After speaking with the Selkers a few weeks ago, it dawned on me that these hoods are essentially just a miniature version of our underwater habitat – same materials, same manufacturing process, very similar life support concepts. So, it was a fairly seamless pivot from underwater tech to respiratory tech. In some ways, I’ve then been working on oxygen hoods for almost a decade! Our manufacturing partner for the hoods, Subsalve USA, is the company that did some initial prototypes of our underwater tent, so very familiar with this type of manufacturing process. The other linkage to medicine and respiratory care is a project I coordinated from 2004-2007 that we called ‘Diving a Dream’. This enabled the lifelong wish of a fellow named Matt Johnston to go diving. The challenge – he has Duchenne Muscular Dystrophy and is vent dependent with a trach, and full quadriplegic. With Matt, we figured out how to manipulate a ventilator to supply him with breathing air underwater. He is still with us, and a living legend, and a really smart guy. Matt is my key advisor for all things ventilator related. The project was featured on NBCs Today Show. Infographic about how the helmet based ventilation works More infographics.

Chicago 4/10/2020 All I want for Christmas is to hear somebody like Virgin Galactic say "... so you need more helmets ... hold my beer" and it's happened! @TheSpaceshipCo "We worked to increase production by financing manufacturing machines and sending a team of experts to increase production flow. The team onsite is being led by Byron Henning, one of our top engineers." Virgin Galactic and The Spaceship Company, as part of the Antelope Valley COVID Task Force, have collaborated with some incredible partners like Sea-Long to design and build NIV Helmets "patient oxygen hoods", which are being tested at Antelope Valley Hospital. The owner of Sea-Long Medical Systems Inc Mr. Christopher Austin recalled the phone call he had received from Virgin Galactic in his interview for NBC news. The team has designed and built several prototype patient oxygen hoods, which allow oxygen-rich pressure to support those admitted with COVID-19 – opening up the alveoli in the lungs and helping to delay or prevent Acute Respiratory Distress Syndrome (ARDS) from developing. By mitigating ARDS, the team hopes this will then reduce the subsequent need for ventilator support. You can find more information in the article on Virgin.com

Chicago 4/9/2020 Stony Brook, NY – Anecdotal experience from physicians working with COVID-19 patients worldwide are finding that intubation may not be the best choice. Some patients may be unnecessarily being intubated, according to a New York emergency medicine physician. “The problem with (intubation), when you think it through, is all of us, to some extent or another, have locked into our collective subconscious the ARDS-net experience, and the gradual upping of PEEP as a response to hypoxemia -- sometimes even not so gradual, sometimes rapid,” said Scott Weingart, an emergency medicine physician at Stony Brook Medicine Hospital, Stony Brook, NY. The acute respiratory distress syndrome (ARDS) approach might not be the best protocol, according to some physicians, who feel that the virus is resembling high-altitude pulmonary edema (HAPE) in some patients, and should not be treated like ARDS. According to an article published in Medscape, Dr. Luciano Gattinoni of the Medical University of Göttingen in Germany, and his colleagues believe protocol-driven ventilator use for patients with COVID-19 could be doing more harm than good. In a letter to the editor published in the American Journal of Respiratory and Critical Care Medicine on March 30, and in an editorial accepted for publication in Intensive Care Medicine, Gattinoni noted that COVID-19 patients in intensive care units in northern Italy had an atypical ARDS presentation with severe hypoxemia and well-preserved lung gas volume. Instead of high positive end-expiratory pressure (PEEP), physicians should consider the lowest possible PEEP and gentle ventilation-practicing patience to “buy time with minimum additional damage,” according to the letters and article published in Medscape. Dr. Cameron Kyle-Sidell, a physician trained in emergency medicine and critical care and practicing at Maimonides Medical Center in Brooklyn, NY., agreed with the high-altitude concept. “This is not to say that the pathophysiology underlying it is similar, but clinically they look a lot more like high-altitude sickness than they do pneumonia,” Kyle-Sidell said in a Medscape interview. In a recent webinar, Weingart said physicians have been receiving input from physicians worldwide – including those from Italy and China, who dealt with the virus head-on. Intubation too soon can cause issues and less favorable results for patients with COVID-19. “What could happen to these ‘happy hypoxemic’ patients who are intubated early, is that due to that hypoxemia, they may work their way up the PEEP scale and actually a lot of the ALI (acute lung injury) may actually be iatrogenic (illness caused by medical examination or treatment),” Weingart said. If you take a normal person and have them on a PEEP of 20 with mechanical mandatory breaths above that, that might be injurious levels of intubation for these patients with already damaged lungs. As referred to many times, this virus is unprecedented – and may require physicians to think outside the typical protocol for treating COVID-19. "This is a kind of disease in which you don't have to follow the protocol – you have to follow the physiology," Gattinoni said. "Unfortunately, many, many doctors around the world cannot think outside the protocol." Physicians throughout the country – including those in Italy -- feel many COVID-19 patients can avoid or delay intubation and be at less risk for iatrogenesis, Weingart said. While not willing to name the hospitals at this time, Gattinoni said one center in Europe has had a 0% mortality rate among COVID-19 patients in the intensive care unit when using this approach, compared with a 60% mortality rate at a nearby hospital using a protocol-driven approach. They have also seen indications of lower blood pressure and better mental status, when patients are not intubated, according to Gattinoni’s comments in the Medscape article. Getting health institutions on board with this way of treating COVID-19 is a challenge, according to Kyle-Sidell. “We are desperate now in the sense that everything we are doing does not seem to be working,” Kyle-Sidell said in an interview on Medscape. “So we've reached a point that most other diseases have not reached, where many physicians are willing to try anything that may help because so little seems to be helping.” Most COVID-19 patients are started on nasal cannulas, Weingart said. Non-rebreathers combined with surgical masks have been helping, as well, Weingart said. “The last thing we are just about to start instituting is a trial of CPAP,” Weingart said, citing the “remarkable” success rate Italian physicians have had using helmet-based CPAPs. Companies are making (helmets) in the US as we speak.” Weingart cited comfort and lower aerosolization as just two benefits of the helmet-based ventilation. Another huge benefit of the helmet-based method is the ability for a COVID-19, based on Italian experience, is patients can change positions easily. “These patients can do exactly what they do in bed at night, which is self-position,” Weingart said. “It’s not the same misery of an intubated patient proning procedure, which is dangerous and requires a huge amount of work.” The helmet-based ventilation requires less hands-on needs from medical staff, and is more comfortable for the patient, while sedation, intubation, and proning are difficult for the patient and require more staff monitoring. Click here for Dr. Gattinoni ‘s proposed treatment model. Webinar on Avoiding Intubation and Initial Ventilation in COVID19 with Dr. Weingart.

Updated on daily bases Since we've launched this website on 3/18/2020 our lead Aurika Savickaite has already talked with the New York Times, WSJ, Huffington Post, and others. Fortunately and unfortunately at the same time, the interest in non-invasive ventilation methods is growing exponentially every day. Doctors in the US are starting to realize how many disadvantages mechanical ventilation has (if you have the ventilators AND all supplies). We will be updating this page with the latest developments. Please share this information with everyone involved in the fight against the COVID pandemic. A partial list of media appearances JAMA Livestream (Thursday, March 25, 2021) Helmet Noninvasive Ventilation of COVID-19 Patients Domenico L. Grieco, MD of Fondazione Policlinico Agostino Gemelli IRCCS in Rome, Jesse B. Hall, MD of UChicago Medicine, and Laveena Munshi, MD, MSc of UHN Toronto join JAMA's live Q&A series to discuss a trial comparing helmet NIV vs high-flow nasal oxygen (HFNO) for management of hypoxic coronavirus patients. BBC 9/21/2021 Covid: Pressure on ICU staff concerning, Hywel Dda consultant says abc KLAX31 12/8/2020 New Ventilation Therapy Being Used At CHRISTUS St. Frances Cabrini Hospital To Treat COVID-19 Patients RTP News 11/18/2020. São João Hospital professionals in training to apply breathing helmets The Suzi ventilation hood made by SouthMED LTD is a finalist in the Public Good Award category. in The Best Design Awards is an annual showcase of excellence in graphic, spatial, product, digital, and motion design along with three special awards - Value of Design, Public Good, and Toitanga. "With no funding support from the New Zealand government, they created a solution that met the most pressing health crises New Zealand has faced in many years. Their hard work was supported by an exceptional NZ philanthropist who has underwritten the costs to produce the devices to date. His generosity has extended to Nepal and Fiji in June and July 2021 delivering 120 additional devices to support efforts in these regions also. Not only was the device supplied free of charge, it is also superior to other systems for the treatment of Covid19 as it requires only 15% of the oxygen of other systems and has superior air management and ergonomic allowance for patient care than any other hood on the market today." AirMed&Rescue 07/21/2020. US-based air medical transport company Life Link III has rolled out new equipment as part of its ongoing response to Covid-19. CHEST Journal 10/01/2020 Mayo Clinic Jacksonville "Breathing Easier During COVID-19: Hyperbaric Hoods in the ICU" By: Michael Harrison, MD, PhD, MPH; Devang Sanghavi, MD, MHA, FCCP; Klaus Torp, MD; Jorge Mallea, MD; and Pablo Moreno Franco, MD, FCCP Daily Mail 08/28/2020 "Nevada man, 25, becomes the first known case in the US of coronavirus reinfection" WCVB Channel 5 Boston 04/29/2020 "Doctors at Worcester hospital using alternative, noninvasive ventilator" More info from the interview with RT Rachel Carragher The New York Times 04/17/2020 Fears of Ventilator Shortage Unleash a Wave of Innovations NBC News 03/31/2020 "Sea-Long Medical Systems has drawn huge interest from hospitals and foreign countries seeking alternatives in treating COVID-19 patients amid a ventilator shortage." WGN9 TV Chicago 4/01/2020 "Chicago researcher JP Kress MD says helmet ventilators can ease short supply" Hub Focus April 2020 " Precise information about helmet-based ventilation helps medical staff amidst COVID-19 crisis" Sky News March 2020 "Coronavirus: Italy's hardest-hit city wants you to see how COVID-19 is affecting its hospitals" Business Insider 4/9/2020 80% of NYC's coronavirus patients who are put on ventilators ultimately die, and some doctors are trying to stop using them BY OR TODAY MAGAZINE | MAR 27, 2020 HELMET-BASED VENTILATION HELPS PATIENTS, MEDICAL STAFF AMID COVID-19 CRISIS Podcast by Scott Weingart. EMCrit Wee – Stop Kneejerk Intubation with the EMCrit Crew. EMCrit Blog. Published on March 30, 2020 MedicalResearch.com 04 APR 2020 RESPIRATORY HELMETS CAN DECREASE NEED FOR INTUBATION AND SPREAD OF COVID-19 VIRUS / COVID -19 Coronavirus, Pulmonary Disease by Marie Benz MD FAAD 0 Comments

4/6/2020 Chicago As COVID-19 cases - and the need for mechanical ventilators - continue to rise, so does the ripple effect of needs and implications associated with intubation. It’s not just the short supply of mechanical ventilators that continue to impact patients needing intubation – it’s the other issues associated with this use – as opposed to helmet-based noninvasive ventilation. And that includes sedatives – many already on backorder. If a COVID-19 patient has been determined in need of mechanical ventilation, their condition already is considered dire. Many of those diagnosed with the virus are being treated at home via quarantine/isolation. Only those deemed critical – and tested positive for the virus – are being admitted to hospitals and considered for mechanical ventilation. According to reports, only 20% of intubated patients can be expected to survive. But that road – should the patient get there – is a bumpy one, according to recent reports. One of those bumps is the need to sedate the patient, as intubation causes distress and discomfort for the patient. The Food and Drug Administration recently included midazolam – a sedation drug being used for intubated patients – on its shortage list, according to an article in NBC News. Other drugs used to sedate these patients include fentanyl, propofol, and paralytic drugs. Why? Intubation is an invasive and painful procedure requiring the insertion of a tube down the patient’s airway which will allow the machine to take over the breathing. Patients who are intubated often try and pull the breathing tube out; therefore, it is necessary to use sedation to keep the patient calm. It’s painful. And if they fight it and work against the machine, there can be even more damage to their already compromised lungs. A patient is an awake state and restrained would not be able to tolerate mechanical intubation, according to some reports. And patients on mechanical ventilators tend to need to stay on them longer – meaning more drugs, more staff, and more challenges to survival. Another report from Stat News said there has been a more than 51% increased use of these and other sedatives due to the need for mechanical ventilators for COVID-19 hospitalized patients. And, yet, some reports, including one from Vizient, a company providing analysis and advisory services for health systems - indicate the fill rate has dropped to at least 25%. This means some hospitals are unable to get the full amount of medications ordered, adding to an already overstressed situation. More patients. More mechanical ventilators. More drugs. More ICU trained staff. Is there an alternative? Yes -- helmet-based noninvasive positive pressure ventilation. This system can be a solution to many of the above-stated challenges. Helmet-based ventilation does not require intubation, thus eliminating the need for sedation. It also requires less intensive medical care, which can also contribute to less risk and less stress for medical providers. It provides more comfort for the patient and is more cost-effective. Studies have shown patients using the helmet-based ventilation system recover faster, as well. Using helmet-based ventilation can also free up more beds in intensive-care units, as well. Using this method also can free up mechanical ventilators, as the helmet system attaches to wall gases and can also be used with BiPAP machines. Using helmet-based ventilation can not only free up many sources facing demand vs. supply as the COVID-19 continues to peak before a decrease can be expected, it can also be much more comfortable and provide successful outcomes for the patient. As studies from other countries – like Italy, which is starting to emerge from the grips of the virus – show, 20 to 30% of patients with COVID-19 can avoid intubation by using helmet-based ventilation.

April 4 2020 | Chicago | Infographics #3 by HelmetBasedVentilation.com Thank you PrimeLabelStudios.com for design!

Vista, California 4/2/2020 As COVID-19 cases – and deaths – continue to go up in the United States, the search for needed ventilators continues to be a problem for medical facilities and makeshift hospitals. An alternative to invasive ventilators – helmet based ventilation – already being used outside of the United States, is starting to get noticed in communities who are getting hit hard by the virus, according to Mike Malone of Amron International. The company, based out of Vista, Calif., was founded in 1978, manufacturing commercial diving equipment. The Amron oxygen treatment hood (another name for a helmet) was designed in 1998 and holds two patents, Malone said. Based on recent research, Amron’s oxygen treatment hoods (helmets) could potentially be used in hospitals for COVID-19 patients. However, it was designed to be a hyperbaric product, Malone said. “A lot of the hospitals are inquiring about the product and buying smaller quantities at first,” said Malone, vice-president of marketing for the company. “I think the hospitals are going through the process of approving the hoods for this application.” The company has enough product to put out about 500 helmets within the next week or so, Malone said. The company is adding suppliers and tooling to meet the impending demand of devices over the next several weeks. It is challenging to determine how, when, and where the virus will peak to reasonably meet the demand. Due to the supply and the demand, the helmets will be shipped based on a first-come, first-served basis, Malone said. When a hospital calls and needs the helmets, Amron could potentially supply the product. Amron has supplied helmets to Australia, Italy, Germany, and Hungary, with inquiries from other countries including the Netherlands and UK. “A lot of our (worldwide) dealers are calling us,” Malone said. Malone said the company is investing a sizable sum into added tooling to manufacture helmets – he estimated that the helmets cost about $150. “We’re juggling a lot – we’re juggling customer calls, safety protocols for our production team … everything -- trying to get this thing going,” Malone said regarding the impact of the virus on the company and the country. “We’re going off the doctor’s recommendation, and people who have grabbed the hood have spoken very highly of the hood,” Malone said, talking about a video from Tom Fox. Fox is the Research Physiologist for the Hyperbaric Institute for Research and Training, a division of Island Hyperbaric Centre in Pincourt, Quebec, Canada. He used one of the Amron helmet based ventilators to show the uses of the product for COVID-19 patients. “(Fox is) very passionate about this prospective use,” Malone said. As the virus is unprecedented, Amron International hopes to be able to contribute to help patients recover from COVID-19. “We are getting a lot of inquiries from Central and South America, as well,” Malone said. “They are also calling me believing they’re going to need our hoods in the very near future.  Hospitals don’t have enough respirators … period.”

UK could benefit from success in other countries in the COVID-19 battle. Chicago 4/1/2020 As countries continue to venture into the unknown battle against COVID-19, questions arise about the best practices to eradicate the virus and save lives. The United Kingdom only recently advised residents to observe social distancing – and may have further put patients at risk by using a Continuous Positive Airway Pressure (CPAP) face mask device for treatment. Pulmonologists around the world treating COVID-19 patients warn noninvasive positive pressure ventilation (NIPPV) via face mask is not safe for patients or medical staff. Clinicians in the UK are more comfortable working with CPAP face masks as they have been using them for a long time. A better, safer option for all is helmet-based ventilation, which creates a closed system with little or no air leaks, along with an antiviral filter providing another barrier against the spread of coronavirus. This is an obvious benefit to medical personnel who are in constant contact with many patients. Helmets are common in Italy, and hospital staff has had success using them to treat COVID-19 patients. A helmet also is a better alternative for patients -- they can eat and drink without creating an air leak. It also is more comfortable and avoids the breakdown of skin experienced by wearing face masks for a long period of time. A three-year study at the University of Chicago showed patients using helmet-based ventilation improved faster, had fewer days in the ICU and hospital and were less likely to need intubation. Doctors in Italy have had 20-35% success using helmet-based ventilation among COVID-19 patients. According to international guidelines for COVID-19 patients, a helmet is preferred when applying noninvasive positive pressure ventilation (NIPPV). Pulmonologists who have worked with COVID-19 patients in respiratory distress have warned about spreading the infection using masks or high-flow nasal cannulas. Excerpt from: “International Pulmonologist’s Consensus on COVID-19” Chief editors: Dr.Tinku Joseph (India), Dr. Mohammed Ashkan Moslehi (Iran). A CPAP device was re-engineered by Formula One engine manufacturer Mercedes with University College London engineers and clinicians, CNN reported. Article: Mercedes F1 help develop coronavirus breathing device for health service use The United Kingdom is testing 100 of these redesigned devices on COVID-19 patients this week. The CNN article states CPAP devices have been used in China and Italy to treat COVID-19 patients and that roughly half of patients have avoided the need for ventilators. What the article doesn’t say is that in Italy, medical staff use helmets for NIV. A BBC Newshour interviewer asked Professor Rebecca Shipley about this concern. Shipley is director of the Institute of Healthcare Engineering at University College London, who collaborated on the new Mercedes CPAP device. “Obviously, the protection of health care workers is exceptionally important,” Shipley said. Shipley said all the indications -- both within the UK, and, for example in Italy and China – suggest that if health care workers are wearing the appropriate personal protective equipment, the chance of transmission is extremely low. Based on Shipley’s comment, every listener should ask these questions: Italy uses helmets, so health care workers are more protected. How does that factor into face masks? How do medical workers stay safe with a shortage of personal protective equipment (PPE) around the world? Based on data from Italy, patients require days of NIPPV to recover. Face masks are difficult for patients to tolerate. Why choose a face mask design? While these questions likely were asked during the development of the redesigned CPAP face mask, it looks the same and continues to present problems for patients and doctors. Increasing amounts of time, money, and effort are being expended to battle and conquer COVID-19. If we can’t adapt to new guidelines – and learn from those who already have been in the fight, we are not just losing a battle, we are losing the war.