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Intubation is a costly procedure. It requires admission to the ICU and increases the length of a hospital stay for most patients. Each year, a quarter (1.1 million) of the 4.4 million people admitted to the ICU in the United States have an acute respiratory failure (ARF). In 2005, the average length of ICU and hospital stay was 14 days for patients with ARF. Total hospital costs for the care of intubated adults was $27 billion, or 12% of all hospital costs in the United States. (1) Before the coronavirus outbreak, it was estimated that ICU mechanical ventilated patients would increase to 5.5 million in the year 2020, with annual hospital costs over $64 billion. (2) ICU fixed costs are higher as a result of greater nurse and other personnel staffing and more observation equipment. Patients using mechanical ventilation have greater variable costs, which include medications, blood products, laboratory tests, and supplies. They also are at higher risk of costly complications, such as ventilator-associated pneumonia (VAP), catheter-related bloodstream infections (CLABSI), sepsis and gastrointestinal hemorrhage. Noninvasive positive pressure ventilation (NIPPV) can be a good alternative to artificial airway and IMV while also minimizing the cost of care for patients without compromising clinical outcomes. Studies show NIPPV reduces the length of hospital stays, reduces the rate of endotracheal intubation and decreases the mortality rate. (3), (4), (5) NIPPV and effective medical interventions for selected patients will reduce medical costs and improve patient outcomes. 1. Wunsch, H., Linde-Zwirble, W.T., Angus, D.C., et al. (2010). The epidemiology of mechanical ventilation use in the United States. Crit Care Med, 38, 1947–53. 2. Zilberberg, M.D. & Shorr, A.F. (2008). Prolonged acute mechanical ventilation and hospital bed utilization in 2020 in the United States: implications for budgets, plant and personnel planning. BMC Health Serv Res, 8, 242. 3. Keenan, S.P., Sinuff, T., Cook, D.J., & Hill, N.S. (2003). Which patients with acute exacerbation of chronic obstructive pulmonary disease benefit from noninvasive positive-pressure ventilation? A systematic review of the literature. Ann Intern Med, 138, 861–70. 4. Ferrer, M., Esquinas, A., Leon, M., Gonzalez, G., Alarcon, A., & Torres, A. (2003). Noninvasive ventilation in severe acute hypoxemic respiratory failure: a randomized clinical trial. Am J Respir Crit Care Med, 168(12), 1438-1444. 5. Agarwal, R., Aggarwal, A.N., & Gupta, D. (2006). Is there a role for noninvasive ventilation in acute respiratory distress syndrome? A meta-analysis. Respir Med, 100(12), 2235-2238

Today, mask intolerance and discomfort still represent a major cause of NIPPV failure. And here is another reason why it can be. This paper published significant upper airway findings for patients who used Face-Mask NIV or Helmet NIV. Great article with a quick summary and key points for Helmet-based ventilation. Keep in mind that Helmet CPAP and Helmet PSV are often lumped together under the broad umbrella of Non-invasive ventilation. 1. Helmet CPAP therapy markedly improves oxygenation in COVID patients and the intubation rate is lower in patients treated with Helmet therapy than in those treated with HFNO 2. Helmet CPAP is a safe and effective treatment option for immunocompromised patients with ARF 3. Helmet CPAP benefited patients (non-COVID) rescued by nurses in the absence of any pharmacological intervention, implying that CPAP should be used as a first-line intervention even before standard medical treatment! CONCLUSIONS: In the subjects with COPD with exacerbation, NAVA through a helmet improved comfort, triggering performance, and patient-ventilator synchrony compared with pressure support through a face mask. Noninvasive Positive Pressure Ventilation for Treatment of Acute Respiratory Failure in Immunocompromised Patient Aurika Savickaite RN, BSN - Rush University College of Nursing Do you know more relevant research? Please send it to us.

General FAQ Q: What is this website about, are you selling anything? A: Originally this is was non-commercial private citizen initiative to organize information and help health care professionals learn the benefits of noninvasive ventilation (NIV) via the helmet. We publish information about the manufacturers, inventors and funding sources to help them connect so they can speed up the production of working helmets. In 2021 we've incorporated and published an online course to help train medical professionals "A Step-by-Step Course on Helmet Based Non-Invasive Positive Pressure Ventilation for COVID and non-COVID patients". We do not sell actual helmets, you can purchase the helmets directly from manufacturers and distributors. Q: What would helmet-based ventilation concretely bring in the present COVID-19 crisis? A: Noninvasive ventilation (NIV) via helmet reduces intubation. Also, helmets can be used without a ventilator and outside of the ICU, allowing ventilators and ICU beds to be used by the illest patients. FAQ about buying helmets > BUY a Helmet! Where to get a Helmet? (updated 24/7) Q: Can I buy one or a few helmets for personal use? A: No, not only there are not enough for hospitals, but manufacturers in the US are not legally allowed to sell to non-licensed doctors. Q: Is there a way individuals can buy these to donate to our local hospital? A: If you want to help - you can collaborate with hospitals and share information about helmet based ventilation Q: How much do helmets cost in the US? A: The price range for the helmet only is $125 - $200. Some companies sell helmet kits which include PEEP valve, filter, and other adapters. FAQ about making helmets or helping with parts, logistics > BUY a Helmet! Where to get a Helmet? (updated 24/7) Q: We are manufacturers where can I get the drawings? A: This repository, provided by "COSMIC Medical", contains all the design files necessary to build a bubble helmet device capable of providing non-invasive positive pressure ventilation. Updated 07/20/2020 We are aware that the Sea-Long Medical Systems Inc. owner Christopher Austin mentioned in the interview to NBS that he want to share drawings, but as of yet we don't have information about it. You can signup to our email list, we will send an email as soon as we can guide you to how to get the drawings. Posted 04/2020 Q: Many people are building helmets and looking to see what has or has not worked for others. A: You can find more information about helmet production and manufacturing on Facebook Public Group "NIV Helmet Manufacturing Project to Combat COVID-19". Some inventors are sharing designs and manufacturing tips for free. https://www.helmetbasedventilation.com/post/where-to-get-a-helmet-for-helmet-based-ventilation Q: Can we 3D print Venturi Valve? A: There are some companies that share Venturi Valve designs for free: GrabCad Community This list is updated on regular basis.12/19/2020 FAQ for Medical Professionals > More information for Doctors, Nurses and other Medical Professionals Q: Are helmets superior to face masks. A: JAMA 2016 study showed a dramatic reduction in the intubation rate compared to face masks. Helmets were shown to be dramatically better than face masks in ARDS. Q: Helmets are said to be more expensive than face masks. Is it true? A: Yes. But it is more effective in preventing intubation than a face mask. Intubation is very expensive in comparison to a helmet. Price for helmet $150 in the US. Q: Helmets have existed since 2003 but don’t seem to have met success among ICUs. A: The FDA (Food and Drug Administration) has not approved the European device in the USA. However, helmets are used widely in Europe. Q: Very often, tubes that are available in hospitals are not compatible with new devices. A: This is a valid point. Respiratory therapists are a good resource for connecting tubes. Here is how you can set up the helmet to use without a ventilator, only with wall oxygen or BiPAP! (Video link Updated 04/02/2020) Q: Which countries are using helmets for NIV? A: Europe - Lithuania, Germany, England, and especially Italy. Q: Medical staff feels uncomfortable by using this new device. A: This can be learned fast and it’s not a new practice. If the physician or/and his critical care team can’t figure it out - don’t use it. In the USA we will be connecting two patients to one ventilator very soon - this practice is not used on a regular basis. The helmet is one more resort that we have to prepare to use. We, clinicians and hospital leaders, have to act faster than the government to stop COVID-19. Q: If you have a patient on just oxygen/airflow with a helmet setup, what’s the difference between that and CPAP? A: Nothing. It is a CPAP helmet without a ventilator. Q: Can you connect multiple patients on helmets to one ventilator? A: Theoretically. But you’re better off using endotracheal tubes if it comes to that. Q: The Engineers are wondering if - the 100% oxygen flow is too dangerous and if 100 L/min is a high amount of consumption? A: 100% FiO2 can cause lung injury if used for a long time. That’s why the medical air is there. Airflow 100 L/min is not too high - the helmet has a large volume. Update 04/02/20 - with 60 L/min flow you can achieve 8-10 of PEEP. With 110-150 L/min flow you can achieve 20-25 L/min of PEEP. Q: What you need for the helmet to work? A: You must have a reliable fresh gas flow. You can do that one of two ways: with a ventilator and the ventilator is set to pressure support. See the UofC study led by Dr. Bhakti Patel. Or you can do it with the fresh gas flow from off the wall. Update 04/02/20 See the video by Dr, Patel. Also, you can connect the helmet to BiPAP V60. Q: What setting should I use if I connect the helmet to the ventilator? A: The take-home message is - If you’re gonna use a ventilator, you have to hook it up with pressure support. Q: What should you NOT do? A: Don’t place patients on a ventilator and set it to CPAP with no pressure support. Because if you do that, you will rebreathe CO2, and that’s what Taccone’s study showed. Updated 05/11/20 Reference: Taccone P, Hess D, Caironi P, Bigatello LM. Continuous positive airway pressure delivered with a “helmet”: effects on carbon dioxide rebreathing. Crit Care Med 2004;32(10):2090-2096. Q: Why you can NOT connect the helmet to the CPAP machine? A: If the patient is on a CPAP machine, it will depend on how strong the patient is to move the fresh gas into the circuit. So if I’m on CPAP and I’m young and strong and I can draw big breaths in and out, I will generate a substantial amount of fresh gas flow. But if I’m not young and strong, or if I start to get weak because I’m working, wearing out, the rate of fresh gas flow into the helmet will fall off substantially. And that’s what Catani and his group showed. Reference: Principi T, Pantanetti S, Catani F, Elisei D, Gabbanelli V, Pelaia P, Leoni P. Noninvasive continuous positive airway pressure delivered by the helmet in hematological malignancy patients with hypoxemic acute respiratory failure. Intensive Care Med 2004;30:147-150. Q: Can I transition the patient from the helmet connected to the gas flow to the ventilator pressure support if he starts to deteriorate? A: Today, we have the limited resources about COVID-19 patients, but what we hear from the frontline is that many of these patients seem to just take a downhill turn without much of a heads up. I think we are probably better off not trying to go from Helmet CPAP off the wall to a ventilator. We have to intubate. In the first hour or two, you’re going to know if the patient tolerating it well or not. Based on feedback from Prof. Pesenti, is that the good news is if it’s working it’s pretty obvious. The bad news is if it isn’t working you need to act fast! Because if you futz around, you’ll be dealing with intubation while you’re doing CPR. ADVICE from Prof. John P Kress: Keep it simple! “The setup that we have is much simpler because you don’t need a ventilator. If ventilators become limited, then that’s a nice feature. If noninvasive continuous positive airway pressure (nCPAP) delivered by the helmet without a ventilator isn’t working, the advice that I’m hearing from others, and I would give the same advice, is you just have to intubate.” Q: Are there cleaning instructions for helmets? Is the helmet a single patient use? A: Some hospitals have a process of sterilizing the helmets by using a hydrogen peroxide application, so it can be reused again. Helmets from different companies have different sterilization guidelines. For example, Amron International Hood can be sterilized or disinfected by means of autoclave, Gama, gas sterilization, and fast-acting germicidal disinfectants. Just keep in mind that helmets with a customized collar can be used for someone who has a similar neck size. Also, the collar part for these helmets can be replaced. Dr. Cereda from Penn Medicine shared the Sea-Long Helmet disinfection process document from his hospital. 05/28/2020

Ventilation via helmet is being used in European hospitals to treat COVID-19 patients, according to a doctor at a university hospital in Lithuania. Dr. Gintautas Kekstas confirmed the use of helmets to provide ventilation to patients at Vilnius University Hospital Santariškių Klinikos in Vilnius, Lithuania. Dr. Kekstas is a director and works in the Intensive Care Unit. Kekstas said the Vilnius hospital has enough helmets, and production isn’t an issue right now. He also said helmets are highly used in Europe and specifically mentioned Italy, Germany and England. The helmets were made by UAB Intersurgical in Lithuania Helmet-based ventilation is a noninvasive alternative to intubation to help patients in respiratory distress. A three-year clinical trial at the University of Chicago Medical Intensive Care Unit has shown noninvasive ventilation (NIV) via helmet is more effective than using a mask and results in better outcomes for patients who improve faster, spend less time in the ICU or hospital, and experienced lower mortality rates.

Sea-Long Medical Systems Inc., a Texas-based manufacturer, is increasing production to meet additional demand for its clear plastic helmets to help COVID-19 patients. Owner Mr. Christopher Austin said in an interview with Aurika Savickaite that demand for the helmets used to provide noninvasive ventilation (NIV) is very high. Sea-Long is the only producer of these helmets in the US. Helmet-based ventilation helps patients in respiratory distress. A clear helmet with a soft collar is fitted over the patient’s head, and air and oxygen are pumped in to help fill the patient’s lungs and keep airways open. A three-year study of ventilation via helmet shows this solution reduces the need for intubation, helps patients get better faster and reduces the mortality rate. The helmets are particularly helpful with COVID-19 patients because they create a closed system with no or little air leaks. Additionally, the helmet ventilation system includes antibacterial and antiviral filters. Austin said that by using the NIV helmet, clinicians can keep the virus in the system and filter it out, which means they can be used 100% by patients who have the coronavirus. Helmet ventilation is safer for staff and better for patients. Austin said the company is increasing production as much as possible, and federal agencies are helping them produce more helmets. While Sea-Long would like to be able to meet all demands, Austin said his company won’t be able to supply enough helmets, and there will be delays. Other helmet manufacturers in the US make parts for the ventilation systems, but Sea-Long is the only producer of the helmets.

USA Distributor for Italian StarMed CaStar R Hood, New York FDA EUA Approved As of August 14th, 2020. StarMed Helmet is approved by the FDA to use for non-invasive ventilation and CPAP in the hospital environment. The treatment may only be performed under careful monitoring by expert operators. Suitable for treatment of respiratory insufficiency in hypoxemic/hypercapnic adult patients. You can send your inquiry directly to the manufacturer here Hands-On Review Video - NIV StarMed CaStar R Hood from Intersurgical Ltd Italian DIMAR CPAP and PSV Helmets FDA EUA Approved DIMAR CPAP and NIV helmets received FDA EUA approval on April 20th, 2022. USA Manufacturer Rhode Island (Shipping now) FDA EUA Approved for non-invasive ventilation and CPAP use in a hospital environment Maternova Inc. - "Subsalve" Helmet Distributer in Latin American countries The Health Bank - "Subsalve" Helmet Distributor in the Middle East, Nigeria, and South Africa "Effective August 4, 2020. The device has been added to Appendix B of the FDA’s EUA for ventilator accessories, and is specifically indicated for the treatment of ARDS resulting from Covid-19. At the present time, the Subsalve Oxygen Treatment Hood is the only such device with this specific indication as authorized by the FDA" Michael Lombardi. 4/9/2020 Lombardi Undersea LLC in partnership with Subsalve USA, both of Rhode Island USA is producing and shipping oxygen treatment hoods. Orders can be placed online or by submitting a PO to Michael Lombardi at michael@lombardiundersea.com. Read More The nHale + Hood configuration nHale™ provides bi-level positive air pressure and CPAP to support respiratory therapy for spontaneously breathing adults. An instructional video for nHale and Subsalve hood connection: PEEP-Alert is an accessory that provides continuous monitoring of positive pressure therapy and has Audible/visual alarms. Authorized by the FDA for Emergency Use (EUA) and by Health Canada under COVID-19 Interim Order USA Manufacturer Texas FDA Approved for use in Hyperbaric Facilities Sea-Long Medical Systems Inc Waxahachie, TX 75167 USA Manufacturer California FDA Approved for use in Hyperbaric Facilities Amron International, Inc Vista, California Mike Malone, Vice President Sales, Phone: 760.208.6500 NIV/CPAP/BIPAP Hood's Description and Features USA Manufacturer New York Filed for FDA EUA Approval You can order this helmet directly from the manufacturer here. Hands-On Review Video - VYATIL Oxygen Tent from The LMD Power of Light New Zealand FDA Registration on Suzy MCP-Tent-001, Available in the USA SouthMed Dunedin, New Zealand. Sales contact: enquiries@southmed.co.nz Suzy MCP-001 Respiratory Hood available in New Zealand Italy DIMAR s.r.l. Medolla, Italy Harol, Milan, Italy Video instructions. Intersurgical Ltd. Mirandola, Italy UK Armstrong Medical. Coleraine, Northern Ireland. CPAP Helmets / Hoods deliver CPAP safely while providing great patient comfort and aerosol-protection for staff: The FD140i provides a dedicated CPAP Helmet Mode with enhanced safety features: Intersurgical Ltd. Berkshire, UK Lithuania Italian manufacturer's representative: UAB Intersurgical Arnionių g. 60, LT-18170 Pabradė, Lietuva India Manufacturer Phoenix Medical Systems, India (Shipping Now) Hands-On Review Video and more info about Haven Hood Canada Alberta COVID CPAP Hood - Scott Loree "I have been working for 4 weeks with Tom Vermeeren, from Gemma Plastics in Edmonton, Alberta, to develop a locally manufactured version of this helmet system. We have received Health Canada approval 4/24/2020, and are ready to move into manufacturing. " Poland DYI initiative by Marek Macner - Helmochron is in Polish language new word - helm = helmet and ochrona = protection. USA Manufacturer Michigan (Working prototypes are being tested in hospitals 4/14) Filed for FDA EUA Approval A manufacturer located in Zeeland, MI. They have been working with multiple hospitals testing helmets. You can order a helmet here. Contact: Nick Flesher phone: 616-283-3342 DIY & Additional Resources List of companies offering to help make more helmets. (Updated daily) Our goal is to help make more helmets faster and educate medical professionals! We are adding information about companies offering to help to this public spreadsheet so everybody can connect directly (started on 4/1). Link: https://hi.switchy.io/HELP-Make-Helmets Facebook Group "NIV Helmet Manufacturing Project to Combat COVID-19" The objective of this group is to design and create a working NIV Helmet and to release all associated 3D printing files, bill of materials, and building instructions online so that anyone around the world may build one in an emergency situation in order to Combat COVID-19.

Patients who use helmet ventilation can breathe better, recover faster and avoid intubation. Patients who use helmet ventilation can breathe better, recover faster and avoid intubation. It helps protect a patient’s airways and reduces or eliminates the need for sedation. It decreases the risk of nosocomial infections. It’s more comfortable and safer for select patients. “Using helmet ventilation reduces the need for endotracheal intubation.” Using helmet ventilation reduces the need for endotracheal intubation. Additionally, during a clinical trial over a three-year period, researchers found using helmet-based ventilation reduced the length of time a patient was in the ICU and hospital. Most importantly, there was a significant reduction in the 90-day mortality rate with helmet ventilation. From a medical provider standpoint, helmet ventilation shortens a patient’s stay in the ICU and the hospital, which means beds and equipment can be used to serve more people. Additionally, it’s more affordable. Each helmet costs about $100. Image Credit: University of Chicago Hospital

Pros of Helmet NIPPV (noninvasive positive pressure ventilation) Improved oxygen saturation, serum pH; Reduced respiratory rate and heart rate Less pressure on the skin, preventing necrosis, air leaks and discomfort Patient can speak, cough and have full view of his/her surroundings Helps maintain NIPPV for a longer period of time vs. face mask Can be used for an extended period Cons of Helmet NIPPV Asynchrony and noise A lower decrease in PaCO2 vs. face mask group

A goal of noninvasive breathing assistance is to prevent intubation, which results in an increase in drug use, supplies, nursing care and costs for treatment. Helmet ventilation uses a clear air-tight device that surrounds the patient’s head and is sealed with a soft collar that wraps around the patient’s neck. It allows the patient to see, speak and cough. A goal of noninvasive breathing assistance is to prevent intubation, which results in an increase in drug use, supplies, nursing care and costs for treatment. Intubation requires ICU beds and has a higher risk of complications. Traditional noninvasive breathing assistance is relatively ineffective for patients in acute respiratory distress. It is administered via a full-face mask, which typically begins to show air leaks when the required pressure exceeds 15-20cm H2O. The helmet is less likely to have an air leak. It maintains positive air pressure, which helps keep the airway open and improves gas exchange. A helmet is more comfortable for the patient, because it doesn’t touch the face, and he/she can communicate and help clinicians with the assessment. Helmet-based ventilation is especially important with COVID-19 treatment because it minimizes exhaled air dispersion due to minimal air leaks. It helps to stop the spread of the virus from patients to their caregivers. “Traditional noninvasive breathing assistance is relatively ineffective for patients in acute respiratory distress.” Image credit: Intersurgical

Certain criteria are necessary to be able to successfully use helmet-based ventilation with patients. The criteria for exclusion include: Cardiopulmonary arrest Glascow coma scale <8 Absence of airway protective gag reflex Elevated intracranial pressure Tracheostomy Upper airway obstruction Pregnancy Patients who refuse to undergo endotracheal intubation, whatever the initial therapeutic approach Patients who can benefit from helmet ventilation are those who have the following: Hypoxemic failure due to cardiac pulmonary edema and non-cardiogenic acute hypoxemic respiratory failure (AHRF) and/or Shock and/or Ventilatory failure due to chronic obstructive pulmonary disease (COPD)/asthma Additional inclusion criteria include: Intact airway protective gag reflex Able to follow instructions (e.g. squeeze hand on command, make eye contact with care provider, stick out tongue on command) For patients who fail helmet ventilation and need to be intubated, the following predetermined criteria include: Inability to achieve an arterial oxygen saturation by pulse oximetry or arterial blood gas ≥ 88% Respiratory rate > 36 breaths/min Loss of ability to maintain ventilation to keep arterial blood pH ≥ 7.20 Loss of protective airway gag reflex (seizure disorder, severe encephalopathy, Glascow Coma Scale <8) Respiratory or cardiac arrest Intolerance of the helmet or face mask Development of airway bleeding, persistent vomiting and development of copious tracheal secretions