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March 31 2020 | Chicago | Infographics #1 by HelmetBasedVentilation.com Thank you PrimeLabelStudios.com for design.

March 31 2020 | Chicago | Infographics #2 by HelmetBasedVentilation.com Thank you PrimeLabelStudios.com for design.

3/29/2020 Chicago US hospitals are beginning to order helmets to use for noninvasive ventilation for COVID-19 patients, although supplies remain limited. According to an article in The Wall Street Journal, Massachusetts General Hospital, the University of Chicago Medical Center, the Hospitals at the University of Pennsylvania and others are ordering helmets. So far (3/29/2020), only Sea-Long Medical Systems Inc and Amron International Inc. are the only producers of helmets in the US. The Sea-Long company is ramping up production to meet the greater demand but is limiting the number of helmets shipped so “everybody gets some,” owner Chris Austin told The Wall Street Journal. Amron International Inc., a maker of hyperbaric helmets, tested its product for COVID-19 treatment and believes it is safe, according to Mike Malone, vice president of sales. He told The Wall Street Journal that Amron is starting to take orders. Massachusetts General Hospital ordered 20 of the Sea-Long helmets but will only receive five, according to the article. The University of Pennsylvania hospital has received 50 helmets and ordered another 200. Maurizio Cereda, a University of Pennsylvania intensive-care doctor who trained in Italy where helmet use is common, told The Wall Street Journal, “It’s very convenient, something a nurse can manage and can be done on the general floor of the hospital.” The Food and Drug Administration has granted emergency approval for positive-pressure breathing devices to be used in the US during the COVID-19 pandemic, which incorporates helmets for noninvasive ventilation as an alternative device according to a Fact Sheet for Healthcare Providers issued March 24, 2020 Noninvasive ventilation via helmet was studied successfully at the University of Chicago. Researchers found patients using helmets improved faster, were less likely to be intubated and had a lower morbidity rate than those using face masks. Dr. Bhakti Patel, the study’s main author and a pulmonologist at the University of Chicago, said her hospital ordered 100 helmets “for the reality of the time when we don’t have ventilators. We want to preserve ventilators for those who fail the helmet.” They expect 20 helmets this week, according to The Wall Street Journal article. Helmets used for COVID-19 patients in Europe are made in Italy, but they aren’t exporting them to the US because of the great need there. The Lombardy region in northern Italy has been hit hard by the coronavirus, with many patients requiring hospitalization and treatment. HelmetBasedVentilation.com provides updates about helmet suppliers on a daily basis. Please contact us to add a manufacturer name and contact information to the website. Aurika Savickaite explained the project, HelmetBasedVentilation.com, and its mission to Wall Street Journal reporter Mark Maremont. The site was created to organize information about NIV via helmet and help health care professionals learn the benefits for patients with COVID-19. Helmets can be used without a ventilator, attached to hospital wall air and oxygen gas flow. They have been successful for 20% to 35% of patients in Italy during this crisis. We will see these patients on helmet-based ventilation in the US soon. Hopefully, hospitals will receive helmets on time and use them for patients in respiratory distress.

3/27/2020 Chicago An Italian patient Fausto Russo, 38 who is recovering from pneumonia from COVID-19 has shared his experience of using helmet-based ventilation with the media. Video Transcript: I don’t really know what is happening outside my room. Doctors are in and out to check on you. They try to limit contact to a minimum. It’s really lonely. You can’t have your family close by, nobody to support you. The time I’ve spent in hospital has been truly unique. You have to be patient, that’s the most important thing. You must wait and wait. This experience has changed my life. I spent six days and six nights wearing a breathing helmet. It is something difficult to imagine and understand. Time never passes, you can’t find a position to sleep. After six days they took the helmet off because my breathing was improving. They gave me an oxygen mask to wear. Coronavirus walks on the legs of people without symptoms. I didn’t have any contact with people who officially had the virus. Now we just need to stop the pandemic and try to return to normal life as soon as possible. “I spent six days and six nights wearing a breathing helmet. It is something difficult to imagine and understand,” Russo said. “After six days they took the helmet off because my breathing was improving. They gave me an oxygen mask to wear.” Fausto Russo, 38, told journalists from the Foreign Press Club via videolink that coronavirus changed his life. He spoke from the Santa Maria Goretti hospital after being released from an intensive care unit. The video is posted by Guardian News on YouTube. Helmet-based ventilation is common in Europe but not in the US. The goal of our website, HelmetBasedVentilation.com, is to organize information about noninvasive ventilation (NIV) via helmet and help health care professionals learn the benefits of its use for patients with COVID-19. “Italians are lucky to have this option before patients are intubated. In the US, hospitals were not using helmets until this coronavirus pandemic. The University of Chicago Hospital has used NIV via helmet for its patients during a three-year study.” said Aurika Savickaite, the HelmetBasedVentilation.com team leader. Helmet-based ventilation is a safer alternative for COVID-19 patients and their caregivers because it creates a closed system with little or no leaks and filters the air to keep the virus from spreading. NIV via helmet prevents intubation for 20% to 35% of patients.

3/25/2020 Chicago Italy is in the midst of a “tsunami,” according to Prof. Antonio Pesenti, head of Lombardy intensive-care crisis unit. Pesenti is a professor of Anesthesiology and Intensive Care Medicine at the University of Milan, Italy. Yesterday, Prof. Pesenti spoke to John P. Kress, MD, about the helmet ventilation use during the COVID-19 crisis in Italy. Pesenti had predicted high numbers of patients would require intensive care in hospitals, more than they could handle. He told Dr. Kress that about 20% - 35% of patients improve on noninvasive ventilation (NIV) via the helmet. Prof. Pesenti said that when you apply the helmet, you will see results in one to two hours of helmet ventilation. Physicians will see if a patient needs intubation or is recovering from respiratory distress. According to the International Pulmonologist’s Consensus on COVID-19 guidelines we should not use noninvasive positive pressure for COVID-19 patients to prevent the spread of the virus. However, by using NIV via helmet with an antiviral filter creates a closed system to prevent the virus from passing from the patient to the medical staff. Successful use of helmets in Italy shows they are safe and can be used by US hospitals. Excerpt from: “International Pulmonologist’s Consensus on COVID-19” Chief editors: Dr.Tinku Joseph (India), Dr. Mohammed Ashkan Moslehi (Iran). NIV via helmet regularly is used in Italy but is not common in the US. Helmets were used in one hospital during a three-year study. Dr. Kress co-authored a report of that study of helmet-based ventilation at the University of Chicago Medical Center that found patients recovered faster and were less likely to be intubated compared to those using NIV face masks. The Lombardy region in northern Italy experienced the first cases of COVID-19 in the country and has been the hardest hit in Italy. Dr. Kress is a professor of medicine, specializing in pulmonary medicine and critical care medicine. He is the director of the Medical Intensive Care Unit at the University of Chicago Medicine. He is an advisor for HelmetBasedVentilation.com.

3/25/2020 Chicago In the midst of the COVID-19 pandemic, the United States is manufacturing ventilators at a high rate – and with that, comes the need for specially trained staff to care for the intubated patients who are on the ventilators. It is expected that about 2% of those contracting COVID-19 will develop respiratory issues severe enough to require them to be put on ventilators, according to a report on National Public Radio. An alternative to mechanical ventilation is noninvasive ventilation (NIV) via the helmet. This treatment can prove to be a better method on many levels, especially if used early in the treatment. Helmet-based ventilation will cost less, shorten hospital stays and lower mortality rates, according to a study featured in the Journal of Hospital Medicine. The same study also found that the use of NIV resulted in lower mortality rates. Researchers found that for optimum results and best outcomes early intervention with NIV is key, as evidence suggests that delayed use of NIV may lead to severe respiratory acidosis and increased mortality. As opposed to invasive ventilation – intubation – helmet ventilation requires less staffing and puts less stress on the patient. The patient is able to be more independent during their admission, requiring less staff assistance than invasive ventilation. Noninvasive ventilation can be used in non-ICU hospital settings and emergency departments, whereas invasive ventilation should be used in intensive care units only. With proper training and early implementation, noninvasive ventilation can result in higher success rates and quicker recoveries at a lower cost. We recommend hospitals create NIV teams with experts in the field, as suggested in BTS/ICS guidelines.

Our team at helmetbasedventilation.com is not alone in seeking alternatives to help medical workers in the COVID-19 health care crisis. Others are innovating and producing devices to support noninvasive ventilation (NIV) techniques. Engineers at Isinnova, an Italian engineering, and creative firm, have developed a valve to convert a snorkeling mask into a full-face mask for NIV. Dr. Renato Favero, former head physician at Gardone Valtrompia Hospital in Brescia, Italy, reached out to Isinnova with “an idea to fix the possible shortage of hospital C-PAP masks for sub-intensive therapy, which is a concrete problem linked to the spread of COVID-19,” according to the website. Decathlon, the producer of the snorkeling Easybreath mask, provided the CAD drawing of the mask. Isinnova dismantled it, studied it, and evaluated changes. They designed a new component to connect the mask to a ventilator, dubbed the “Charlotte valve.” It can be made using 3-D printing. The prototype was tested successfully on a colleague and on a patient. It’s intended to help in a full-blown emergency situation in which it’s not possible to find official healthcare supplies, the website warns. Neither the mask nor the link valve is certified, and patients would need to sign an acceptance of the use of an uncertified biomedical device. Isinnova states the patent will remain free so all hospitals in need can use it. The file is freely shared, and it’s easy for 3-D printers to use. Hospitals can purchase the mask from Decathlon and connect with a 3-D printer to make the link valves. Isinnova is a team of engineers, designers and communication experts who collect ideas and transform them into concrete objects, according to its website. They help companies and individuals who have an idea to turn it into a finished product. Isinnova also develops internal projects. The company is based in Brescia, Italy. Our team supports the use of NIV via helmet for patients with acute respiratory distress from COVID-19 to help prevent intubation, which is more costly and can cause other health problems. NIV via face mask is another way to support patients in need.

We are a grassroots initiative by expert volunteers to CURATE, CONSOLIDATE & SHARE: WHAT: highly focused & niche expertise on Helmet-based non-invasive ventilation FROM & WITH clinicians, ICU professionals, healthcare decision-makers, manufacturers, suppliers, hospitals, governmental agencies, funders, DYI initiatives ABOUT: most relevant clinical, manufacturing, demand, supply, resources, bottlenecks, solutions, applications, funding needs & sources information WHY: to help saving more lives and contain COVID-19 pandemic. UPDATING 24/7 at www.helmetbasedventilation.com . SUBSCRIBE and choose an area of your INTEREST for curated expertise ​ How YOU CAN HELP: ALERT relevant experts and decision makers about this info source – SHARE a link to our web www.helmetbasedventilation.com SUGGEST tips & solutions to uplift our own grassroots capacity, i.e. tools to augment and automate with a laser focus on this particular niche, donate to help us hire more technical help SUBMIT INFO & contact/capacity/shortage/resource DATA (helmet ventilation related ONLY) on worldwide Clinicians, ICU staff and hospital leaders existing manufacturers, their capacities & needs for supplies or funding to expand output potential pivoting manufacturers, their capacities & needs for expertise, supplies or funding to create new capacity public, private and charity funding sources for hospitals and helmet suppliers hospital demand any other relevant ideas and suggestions ​#StopTheSpread #SharingIsCaring #Ventilator #BiPAP #CPAP #Helmet #NIV #ICU #noninvasive #ventilation #BubbleHelmet #StarMed #SeaLong #CaStar In more simple words: If there are only 1 ICU bed and 10 patients in critical condition, doctors perform brutal triage and chose 1 for hope, leaving 9 to somehow survive or die. Helmet ventilators can save more lives.

Hospitals will need helmets for COVID-19 but they don’t know it. We’ve collaborated with a team from Oregon to help ramp up the production of helmets for ventilation in the US to meet a supply that hospitals don’t even know they will need because of COVID-19. Frank Selker, his brother John Selker, who is a professor at the University of Oregon, along with a couple of other people form the Oregon team. They reached out to the sole US manufacturer of helmets, Sea-Long Medical Systems Inc. Christopher Austin, an owner of the Texas-based medical manufacturer, would like to increase production, but he needs a big order. On a regular basis, Sea-Long can produce 250 helmets per week. John Selker said his group has secured $50,000 from a private firm to cover startup expenses, and the firm has committed another $1 million to order 6,000 helmets in advance from Sea-Long. This should lead the company to reach a 5,000-helmet-per-week production level in one month. The Selker brothers’ team connected with our team as we both looked for alternatives to utilize other noninvasive ventilation options for COVID-19 patients in times when ventilator and ICU bed shortages will hit the US. Hospitals in other countries, such as Italy, have been inundated with patients in respiratory distress, filling ICU beds beyond capacity. Those who are hospitalized with acute respiratory distress need ventilation to help them breathe and recover. Hospitals in Europe often use helmets for ventilation, including Italy, Lithuania and Germany. Helmets especially are helpful with COVID-19 because when used with an antiviral/antibacterial filter they reduce the likelihood of transmission of coronavirus to others. Helmets are produced mostly in Italy for the European market. Hospital staff in the US aren’t as familiar with helmets. Helmets have been tested successfully in the US, but they haven’t been widely used. Their team and ours are not-for-profit groups looking to help clinicians prepare for and deal with the medical crisis that coronavirus presents. We are collaborating to get information to clinicians, connect hospitals with resources and increase production to meet a growing need. Hospital staff members may not know about the helmets, but they are interested when they learn about them. “They do see the problem coming,” Frank Selker said. Now it’s necessary to stimulate demand among others who don’t know about the helmets, Frank Selker said. “If hospitals have some understanding,” Frank Selker said about using helmets and finding alternatives to traditional ventilation, they would be interested. “There’s nothing more persuasive than running out of ventilators. (Hospital staff are) going to be quite interested,” he said. “There’s nothing more persuasive than running out of ventilators. (Hospital staff are) going to be quite interested,” Sea-Long wasn’t in a position to increase production 100 times or even 10 times to meet the anticipated demand by hospitals for helmets, Frank Selker said. “(Christopher Austin) could double production, but it won’t be what’s needed,” Frank Selker said. “In order to scale production to 10 times or 100 times, he needs a big order.” That’s where the private firm money comes in. The Selkers’ team can help prepare Sea-Long to ramp up production and provide a buffer for the small business in the busy time ahead. Additionally, they are making advances in the helmets to improve performance prior to production. The Selkers and their team are looking for other manufacturers who can begin the production of helmets. This is what Selkers team from Oregon achieved in the last 4 days : A private firm has given $50,000 to cover startup expenses and also committed $1 million to order paid-in-advance 6,000 helmets from Sea-Long. This should lead them to 5,000- helmet-per-week production level in one month. An MBA mechanical engineering person is visiting Sea-Long today to fulfill due diligence and give us a green light to fulfill the order. Six videos are shot to support outreach. They are being reviewed by the team before they are released. Helped Aurika Savickaite and her team in Chicago to create content about helmet based ventilation for clinicians, manufacturers, and suppliers We have a survey of demand out to the medical staff to show a need. Today we have over 1,000 orders from medical professionals. We’ve made two significant advances in updating Sea-Long helmets with improved performance. Testing it today! Videos here We have a parallel track to develop a molding machine to reach 100,000 units per week level.

The Swim Noodle Collar Adaptation of the Sea-Long Ventilation Helmet John Selker, John.Selker@Oregonstate.edu - March 23, 2020 Disclaimer: we share tips and ideas from those using helmets, but these may be off-label and un-tested ideas and should not be construed as medical advice, FDA approved modifications, or proven safe or effective. Please consider these with caution. The Sea-Long ventilation helmet provides excellent therapeutic benefits to patients with ARDS (acute respiratory distress syndrome, as is commonly associated with COVID-19). One limitation has been that the pressure in the helmet forces the patient’s head downward, into a poor situation relative to the ports in the device, and so that the hard-plastic rim of the device is right behind the patient’s head. Here we present an adaptation that can improve patient comfort, reduce air volume to improve air exchange and position the patient to have service of the ports in the helmet. The collar is made from a 28.5 inch long (74 cm) long section of 2.25 inch (6 cm) polyurethane close-cell foam cylinder, with a central hole of about 0.75 inches (2 cm) (see images to right). A rubber peg of 0.875 inches (2.2cm) in diameter and 4 inches long (10 cm) is pushed into one end of the noodle, and it may be fixed in place with adhesive (optional). The noodle is put about the patient’s neck, and secured by pushing the rubber peg into the joining end of the ring. The helmet is prepared by putting two strings between the two pairs of opposite strap pegs on the outside of the helmet ring (above). These strings must be taught, so take the care needed to tie small loops on the end of each string to achieve tension when installed. With the strings in place, the patient puts on the helmet, then an attendant takes care that the collar is pushed all the way into the inner ring of the helmet, and secured in place by the strings. We recommend coating the exterior lowest 1-inch surface of the rubber seal with “Skin tac” so that a 2” strip of 3M Blenderm tape will stick to the rubber, and seal the rubber to the patient’s neck. Leakage presents a hazard to the patient and ttending staff. Video

An update on 3/23/2020 from Professor John Selker at Oregon State University Disclaimer: we share tips and ideas from those using helmets, but these may be off-label and un-tested ideas and should not be construed as medical advice, FDA approved modifications, or proven safe or effective. Please consider these with caution. Open tubes in the helmet can make a mess, which causes major cleaning problems. This is a two-part series on using a Camelbak hydration backpack tubes to solve the water-feeding issue inside a Sea-Long pressurized helmet. It is important to position the outlet at the patient's mouth. The swim-noodle collar assists in maintaining a consistent position of the head in the helmet. Below are two videos of using Camelbak hydration backpack tubes for feeding-liquids intake into the Sea-Long helmet. How You Can Help? Share your knowledge We want feedback from the frontline clinicians, who treated COVID-19, to consolidate and share tips and issues, as well as to consolidate info about NIV helmet makers, identify capacities, logistics, bottlenecks, funding needs etc. >>> How You Can Help!

This video shows the process of setting up, fitting and removing the CaStar R NEXT hood. Always refer to the Instructions for Use provided with each product and this video is not intended to replace them. The StarMed CaStar R Next Hood for non-invasive ventilation (NIV) therapy is a comfortable, versatile and lightweight patient interface designed to offer an alternative to traditional methods of NIV. The hood has been designed to improve patient-ventilator interaction, by reducing the inspiratory trigger delay and increasing the rate of airway pressurisation, while avoiding the need for underarm straps. Please visit directly the manufacturer's website for further information or to make an enquiry: https://www.intersurgical.com/products/critical-care/starmed-castar-r-next-hood-without-underarm-straps-for-niv