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

This 2017 Clinical Research Forum Distinguished Clinical Research Achievement Awards-winning study, led by Dr. Bhakti Patel from the University of Chicago, found that the use of a helmet for treatment of patients with ARDS reduced the need for ventilator use compared to the use of the standard face mask, and also prevented one death out of every five patients.

This video shows the process of setting up, fitting and removing a CaStar hood. Always refer to the Instructions for Use provided with each product and this video is not intended to replace them. The StarMed CaStar CPAP Hood for CPAP therapy is a comfortable, versatile and lightweight CPAP patient interface, designed to offer an alternative to traditional methods of CPAP delivery. The hood is well tolerated for extended periods and can reduce the risks associated with both endotracheal intubation and face mask use. Please visit directly the manufacturer's website for further information or to make an enquiry: https://www.intersurgical.com/products/critical-care/starmed-castar-hood-for-cpap-therapy

This video illustrates the equipment and demonstrates how it is assembled and applied with descriptions of initial ventilator settings. In a 2016 single-center randomized trial, noninvasive ventilation (NIV) delivered by helmet significantly reduced the intubation rate among patients with ARDS compared with the patients receiving NIV by face mask. Learn more: https://ja.ma/38R3xbJ.

Non-invasive ventilation using helmets is a patient treatment protocol used at intensive units and hospitals around the world to a different degree. The only USA manufacturer can not keep up with the demand. We all racing with time to #FlattenTheCurve and increase capacities of heathcare infrastructures, while borders are closing between even friendly countries, governments are restricting export activities and many DYI do-it-yourself innitiatives are picking up as we all need to act now and be #FasterThanVirus. Connect us with manufacturers worldwide Please connect us with manufacturers worldwide - share a contact via form https://mttd.wufoo.com/forms/p1a8jhb015g2ty6/ Or, even better, call them, ask a few questions (see the next survey below), ask them to fill-in or do it on their behalf. Please provide manufacturer’s info about products and capacities via form Please also indicate, if you (the manufacturer) give us consent to share publicly your information so that hospitals could order directly. https://mttd.wufoo.com/forms/x5trdac16cg2rd/ We are also consolidating, analysing and searching for solutions to resolve resource, capacity, funding shortages or other bottlenecks. We are working 24/7 to build up relevant, highly-sprecialized quality content, and contribute to containing the COVID-19 outbreak. Come back to our site, refer it to your network, who might benefit from this information, subscribe to our newsletter. #Ventilator #NIV #ICU #BiPAP #CPAP #LungVentilation #Helmet #BubbleHelmet

Do you have first-hand knowledge of using a helmet for noninvasive lung ventilation? Please help by answering these 4 questions through: the survey link below or by recording a brief audio/video on your smartphone and email to us at helmetventilator@gmail.com. Our team will transcribe. Thank you for your precious time and saving lines at the frontline of the COVI-19 pandemic. ​ Share your key 4 learnings at the ICU frontline: Do you use a helmet connected to airflow only (150-200 L/min), no ventilator or other breathing machines? If yes, would you recommend it? What are the positive effects of noninvasive ventilation via helmet for COVID-19 patients in your hospital? Does helmet use help you to save/open ICU beds for sickest COVID-19 patients? Can you say that a helmet use helps to minimize the spread of the COVID-19 virus due to filters in the system? ​ Survey Link >>>  https://mttd.wufoo.com/forms/pv1ekoz1o21wu6/ ​ This survey is being conducted by Aurika Savickaite, RN, MSN, who managed patients with noninvasive mechanical ventilation via helmet and worked closely with the research team at the University of Chicago Hospital. ​ The aim is to collect and consolidate in a single place the newest field-based information from the clinicians, who are or were managing respiratory distress in COVID-19 patients through the use of a helmet for noninvasive lung ventilation. ​ Survey Link >>>  https://mttd.wufoo.com/forms/pv1ekoz1o21wu6/

3/22/2020 As the number of people affected by COVID-18 grows, the Helmet-based ventilation website is focused on providing information and resources for helmet use for noninvasive ventilation in patients who have respiratory distress as a complication of the virus. With medical equipment manufacturers overwhelmed with meeting demands, efforts are being made to reach out to companies who have not previously been engaged in the production of these helmets, including implementing its Emergency Use Authorization process. "efforts are being made to reach out to companies who have not previously been engaged in the production of these helmets" On that end, the US Food and Drug Administration and Health and Human Services are trying to increase the availability of products to help support patients with significant breathing issues, according to a statement from Alex Azar, Health and Human Services Secretary. Wherever possible, health care facilities should use FDA-cleared conventional/standard full-featured ventilators to treat patients. With the current demand of helmet-based ventilation devices, the FDA is interested in connecting with manufacturers of ventilatory support devices not currently legally marketed in the U.S. Additionally, the FDA would like to connect with manufacturers who have not previously been engaged in medical device manufacturing – like auto manufacturers -- but could potentially have capabilities to increase the supply of these devices, according to information provided by the FDA. The FDA will work with these manufacturers through its EUA process, and interested manufacturers can contact the FDA at CDRH-COVID19-Ventilators@fda.hhs.gov. These changes will allow manufacturers and suppliers to adjust their production, equipment, and materials to be able to provide ventilators and increase supplies. Automakers like General Motors and Tesla – whose production lines were temporarily shut down -- will be able to repurpose production lines to manufacture ventilators. The agencies believe the best way to expand production of the needed ventilators is to work with companies willing to revamp and repurpose machines to ramp up production as quickly as possible. There are several key steps to promote the acceleration of production: The guidance describes the agency’s intention to exercise enforcement discretion for certain modifications to these FDA-cleared devices. Typically, approval of any changes can eat up valuable – possibly life-altering – time that it takes to get products to patients. This change will allow non-medical production sites – like the automobile plants – to start making ventilator parts. The FDA is being more lenient in lieu of the current pandemic situation, by not enforcing the premarket review requirement for these types of modifications. Another asset is the allowance of ventilators used for short-term use in ambulances to be repurposed in hospitals. The new guidelines also would allow ventilators at health care facilities to be used beyond their indicated shelf life. As a final measure, the FDC encourages foreign and domestic manufacturers to reach out to the FDA about obtaining an emergency use authorization, allowing them to distribute their ventilators in the United States – including state-side manufacturers who have capabilities to increase production and supply. These efforts are evidence of the FDA’s recognition of the seriousness of the immediate need to step up the production of these life-saving devices. As the number of COVID-19 cases grow by the hour, the FDA is working around the clock to address and resolve the challenges. The FDA is continually updating its frequently asked questions from labs and test developers, providing information on alternative sources of reagents, extraction kits, swabs and more. Additionally, laboratories can call the toll-free line at 1-888-INFO-FDA, with any questions they may have about the Emergency Use Authorization process or getting supplies. The FDA also granted an Emergency Use Authorization to allow industrial-use ventilators to be used in health-care settings and to provide conservation strategies for gowns and masks to make them more readily available for use. Strategies also are being developed for the use of surgical gloves, including extending the shelf life where there is low risk of virus transmission. For more information, click here for the full release from the U.S. Food and Drug Administration.

Italian medical staff prioritize helmets rather than face masks when providing noninvasive ventilation to hospital COVID-19 patients in intensive care units (ICU). An ER nurse who works in Italy also was surprised to learn that helmets are not being used in the US. Staff assumed helmet use was as widespread in the United States as it is in Italy, Valerio Korrado said to Aurika Savickaite via chat. Noninvasive ventilation (NIV) via helmet was tested successfully in a three-year study at the University of Chicago Medical Center. Researchers found helmets were more effective than face masks for patients with acute respiratory distress. Patients using helmets were less likely to be intubated, had fewer days in the ICU and hospital, and had a lower mortality rate. Valerio Korrado, a nurse and triage-nurse in the ER at Ospedale Civile Santo Spirito of Pscara, said hospital staff is using NIV via helmet for COVID-19 patients with mild dyspnea in ICUs, but in the ER they use full-face masks due to an equipment shortage. “Our recommendations say that the first choice for NIV should be helmets,” Korrado said because there is less risk for operators. The national guidelines of SIAARTI (Italian Society of Anesthesia and Intensive Care) advise using a helmet rather than face mask in the ICU for COVID-19 patients who are not intubated, Korrado said. Helmets can create a closed system to limit the possibility of contaminating others, especially when they are used with an antiviral/antibacterial filter. “During specific clinical conditions of the patient, we totally agree about considering this kind of treatment the best practice among the other NIV methods (face or full face) that many times create discomfort and complications, even to the operator that can be easily contaminated,” Korrado said. Korrado added that the helmets usually are connected to a mechanical ventilator, although they can be connected to wall gas. Helmets can be used without mechanical ventilation as an alternative for some patients and provide the same benefits as a CPAP machine would do if ventilators are in short supply. Watch our video to learn how to connect a helmet to wall gases.

Health care providers at a hospital in Italy pause each day at 1 p.m. to call families of their patients who have COVID-19. According to a Reuters article, the noon-hour used to be visiting hours for family, but not anymore. Patients who are hospitalized are isolated from family due to restrictions in place to stop the spread of the virus. Whenever a patient with coronavirus is accepted into his hospital, he says, the staff write an email to their relatives assuring them that their loved ones will be treated “like family.” He says the hospital is trying to activate a system of video-conferencing, so that patients can see their relatives during the 1 p.m. call. Marco Resta, deputy head of Policlinico San Donato’s Intensive Care Unit, said 50% of patients admitted to ICUs in Italy are dying. Hospitals are accepting only patients who need life-saving ventilation. Maurizio Cecconi, MD, head of Anesthesia and Intensive Care at Humanitas Research Hospital in Milan, said in an interview with JAMA Editor Howard Bauchner that his hospital triages patients to determine those who can be sent home and those who need an ICU bed. He said they make no distinction between people who need an ICU bed for COVID-19 or for other reasons, such as organ failure or trauma. Patients who are elderly and with underlying conditions are more at risk for complications of COVID-19, according to the CDC. They are more likely to be hospitalized in intensive care to receive ventilation help breathing. Noninvasive ventilation via helmet is an alternative solution for patients who can tolerate it. Studies have shown NIV via helmet reduces the rate of intubation among patients who get better faster and have a lower mortality rate. However, until the spread is halted, it’s unclear how families will be able to see their loved ones who are hospitalized, particularly those who are sedated for mechanical ventilation.

News reports have shown that COVID-19 patients in Italian hospitals are using helmets with ventilation to help them breathe. Helmets are an alternative to traditional noninvasive ventilation (NIV), which usually is provided via a mask to patients. Italy and other European countries have been using helmets more frequently to treat patients with acute respiratory distress syndrome (ARDS), even before the COVID-19 pandemic took hold. NIV via helmet is an option to treat patients as another step before intubation, which can cause additional health problems and is costly. Helmet-based ventilation was found to be more effective than ventilation via face mask in a three-year study at the University of Chicago Medical Center. The same study found patients improved faster, had fewer days in the ICU and hospital, and had a lower mortality rate. Helmets are being used in Italy now to treat COVID-19 patients who are in respiratory distress from the virus. Some reports refer to them as “bubble helmets,” since they are clear plastic and cover a patient’s head. The helmets provide air and oxygen flow to keep the lungs open and improve breathing in patients. Helmets can be safer for staff and patients with COVID-19 if they are used with an antiviral filter to keep the virus from leaving the helmet’s closed system. See the the video here