Aurika Savickaite 10/14/2026 Chicago A new review in Intensive Care Medicine by Laveena Munshi, Massimo Antonelli and Jean-Pierre Frat finds that helmet non-invasive ventilation (NIV) lets clinicians deliver higher positive end-expiratory pressure (PEEP) "with minimal air leaks" in patients with acute respiratory distress syndrome (ARDS). The review, "Non-invasive respiratory supports in ARDS: Physiology-guided use, pitfalls, and pathways to success," was published on October 7, 2026. It looks at NIV, continuous positive airway pressure (CPAP) and high-flow nasal cannula (HFNC) in ARDS and acute hypoxemic respiratory failure in general. Why it matters Non-invasive support is now used much more often than before. In the earlier LUNG SAFE study, NIV was used in only about 15% of patients with ARDS, the authors note. Today, evidence for HFNC and helmet NIV keeps growing, and the 2024 Global Definition of ARDS now recognizes patients supported without a breathing tube. The goal is to avoid the complications of invasive mechanical ventilation. But the authors warn that strong, uncontrolled breathing effort can injure the lungs, called patient self-inflicted lung injury (P-SILI). What the review found about helmets The authors list several physiological advantages of the helmet interface: Higher PEEP with minimal leaks. "Helmet NIV enables the delivery of higher PEEP levels with minimal air leaks." Asynchronies matter less. Patient–ventilator asynchronies "are generally less clinically relevant than with face masks." Even when an effort does not trigger pressure support, the patient still draws air from the helmet, so it is real work of breathing. A possible lung-protective effect. The authors describe a hypothesis that the helmet's longer trigger delays and less efficient pressurization may limit excessive transpulmonary pressure swings and "potentially" enhance lung protection. This is a hypothesis, not a proven effect. No mask seal problems. Face masks can be hard to seal in patients without teeth, with beards, or with nasogastric tubes. "These inconveniences are minimized with the Helmet interface," the authors write. Fewer intubations than HFNC. Helmet NIV reduced intubation compared with HFNC in patients with moderate to severe hypoxemic respiratory failure (a trial conducted during COVID-19), citing the study by D.L. Grieco and colleagues in JAMA (2021). Starting settings The review suggests reasonable initial NIV/CPAP settings: PEEP of about 5 cm H2O, up to 10 cm H2O. Pressure support of 5–8 cm H2O above PEEP. With the helmet, patients with persistent hypoxemia may need higher PEEP of 8 to 12 cm H2O. Settings should then be quickly adjusted to patient comfort, breathing effort, tidal volume, oxygenation and gas exchange. Where HFNC fits The authors recommend HFNC as first-line non-invasive support for most patients with moderate ARDS, because it can reduce intubation rates. They suggest starting at 40–60 L/min, typically 50 L/min. NIV or CPAP may help carefully selected patients with mild ARDS, without hemodynamic instability and with normal mental status. They state there is not enough evidence to support or reject NIV and CPAP as first-line therapy in ARDS. Both should be used as "time-limited, closely monitored physiological trials," with special caution when PaO2/FiO2 is below 150 mmHg. Knowing when to intubate Delayed intubation is linked to higher mortality in several studies. The review cites French recommendations listing two major criteria for intubation: cardiac or respiratory arrest due to hypoxemia, and persistent hypoxemia despite maximal oxygen support (PaO2/FiO2 below 60 mmHg and/or SpO2 below 88%). For HFNC, the ROX index (SpO2/FiO2 divided by respiratory rate) is the best-validated bedside tool for predicting failure, but it should complement clinical judgment, not replace it. Limitations and what is still unknown The review is honest about the helmet's challenges. With the helmet, "it remains challenging to monitor tidal volumes," which matters because large tidal volumes (more than 9 mL/kg predicted body weight) have been linked to poor outcomes. The authors also note the helmet "may be associated with claustrophobia." Evidence for NIV and CPAP in ARDS is still inconsistent. Much of it comes from older studies of acute hypoxemic respiratory failure, using earlier ARDS definitions. Ongoing randomized trials, HENIVOT-2 (NCT05089695), HighCPAP (NCT06213168) and HONOUR (NCT05078034), are expected to clarify the role of these approaches. A nurse's perspective "In my experience, claustrophobia with the helmet is less common than people expect. Nothing touches the patient's face, the helmet is transparent, and there is a constant airflow inside. Patients can see their nurses and family, talk, and look around. When we explain it well before we put it on, most patients settle in quickly," said Aurika Savickaite, MSN, RN, founder of helmetbasedventilation.com. More studies are needed to define which ARDS patients benefit most from helmet NIV and how best to set and monitor it. To learn how to apply helmets safely and effectively, take our free online course, and subscribe to our newsletter for the latest research. Reference Munshi L, Antonelli M, Frat JP. Non-invasive respiratory supports in ARDS: Physiology-guided use, pitfalls, and pathways to success. Intensive Care Med. Published online October 7, 2026. https://doi.org/10.1007/s00134-026-08616-x Grieco DL, Menga LS, Cesarano M, et al. Effect of helmet noninvasive ventilation vs high-flow nasal oxygen on days free of respiratory support in patients with COVID-19 and moderate to severe hypoxemic respiratory failure. JAMA. 2021;325(17):1731-1743. https://doi.org/10.1001/jama.2021.4682 Tags: ARDS, Helmet NIV, PEEP, HFNC, Intubation, Research, For Doctors

Aurika Savickaite 10/19/2026 Chicago A new review of non-invasive ventilation, or NIV, after cardiac surgery is a welcome addition to the helmet conversation. Its authors note that helmets are being used more because they protect the face and patients tolerate them better, and they raise a fair and important point: helmets "may increase dead space and require careful monitoring." That issue deserves an open discussion, and it has a fix. Carbon dioxide (CO2) rebreathing in a helmet usually comes from the wrong setup, not from the helmet itself. With good training and user-friendly equipment, teams can keep the benefits and avoid the risk. What the review said The narrative review by Mahamaden A. Kery and Hao Cao of Tongji University in Shanghai appears in the October 2026 issue of The Egyptian Journal of Chest Diseases and Tuberculosis. It looks at oxygen therapy, high-flow nasal cannula and NIV for patients whose breathing fails after extubation following heart surgery. "The use of helmet interfaces has expanded in recent years because they reduce facial pressure injuries and improve patient tolerance, although they may increase dead space and require careful monitoring," the authors wrote. Why the helmet has dead space The helmet is a clear hood that covers the whole head. Nothing touches the face, and a soft neck collar creates the seal. That large inside volume is what makes it comfortable. It is also where exhaled CO2 can build up if not enough fresh gas flows through. In our online course, CO2 rebreathing is listed next to armpit skin breakdown as one of the two main helmet challenges. Some helmets have an inner inflatable cushion that adds comfort and reduces the internal volume. The study that explains it A study by P. Taccone and colleagues at Massachusetts General Hospital, published in Critical Care Medicine in 2004, tested helmet CPAP in a lung model and in eight healthy volunteers. When CPAP was delivered with a ventilator in CPAP mode, inspired CO2 was high: 12.4 ± 3.2 torr. When CPAP was delivered with a continuous high-flow system, inspired CO2 was low: 2.5 ± 1.2 torr. The authors concluded that the helmet "should not be used to deliver CPAP with a ventilator," that continuous high flow minimizes rebreathing, and that minute ventilation and PCO2 should be monitored. How to prevent CO2 rebreathing Give enough fresh gas flow. For helmet CPAP in hypoxemic respiratory failure, Dr. John P. Kress of the University of Chicago told us the key is a fresh gas flow of at least 50 liters per minute. His team uses a high-flow nasal cannula setup at 60 liters per minute with a PEEP valve on the expiratory limb. Never use ventilator CPAP mode with a helmet. If you connect the helmet to a ventilator, use pressure support, as explained in our FAQ. Don't copy face mask settings. Helmet NIV and helmet CPAP are different therapies, and face mask CPAP or BiPAP settings can lead to rebreathing and NIV failure. Monitor closely. Watch PCO2, breathing rate and minute ventilation. Our course stresses close monitoring, especially in the first 2 hours of NIV. Learning is the key to success The course names three main challenges of NIV: choosing the right patient, the clinician's level of training and the interface. Dead space falls under the last two. When staff learn the setup, the problem becomes manageable. Equipment matters too. Savickaite's course recommends a simple NIV setup and an easy-to-fit interface so staff can start NIV on time. Kress said the helmet used in the 2016 University of Chicago trial "was not easy to operate." Newer helmets are easier to use, but every team still needs training and clear helmet-specific instructions. The payoff is real. In that 2016 JAMA trial by Dr. Bhakti Patel and colleagues, 18% of patients in the helmet group were intubated, compared with 62% in the face mask group. "Dead space is not a reason to give up on the helmet. It's a reason to train. When nurses, respiratory therapists and doctors understand flow, the PEEP valve and the right ventilator mode, CO2 rebreathing stops being a problem and patients get all the comfort the helmet offers," said Aurika Savickaite, MSN, RN, founder of helmetbasedventilation.com. Limitations The review is a narrative review, not a systematic review, and it focuses on cardiac surgery patients. It does not give helmet-specific flow numbers. The Taccone study was small and used healthy volunteers, not patients. More research on helmet settings in real patients is needed. Learn more Module 4 of our online course, "Helmet NIV Issues and Their Solutions," opens with a lesson on carbon dioxide rebreathing. Module 3 covers titration of PEEP, FiO2 and flow rate. Subscribe to our newsletter for new research and tips. Related reading: Helmet NIV Success: Combining Knowledge and Experience, Helmets Used to Reduce Clinicians' Workload and Improve NIV, our FAQ and our Research list. References Kery MA, Cao H. Noninvasive ventilation for postextubation acute respiratory failure after cardiac surgery: a review of clinical outcomes. Egypt J Chest Dis Tuberc. 2026;75(4):500-508. doi:10.4103/ecdt.ecdt_123_25 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. doi:10.1097/01.ccm.0000142577.63316.c0 Patel BK, Wolfe KS, Pohlman AS, Hall JB, Kress JP. Effect of noninvasive ventilation delivered by helmet vs face mask on the rate of endotracheal intubation in patients with acute respiratory distress syndrome. JAMA. 2016;315(22):2435-2441. doi:10.1001/jama.2016.6338

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.

11/11/2021 Chicago The past two years have brought unseen challenges for all of us, but especially for medical workers all around the world. The novel coronavirus (SARS-CoV-2) has come out of nowhere and placed a significant strain on the healthcare system. No one has known how to deal with the disease caused by a new virus and its related complications. Intensive care units (ICU) were under hard pressure at the very beginning of the pandemic and became crowded immediately. This led to reconsidering treatment strategies for COVID-19 patients and special attention to respiratory support. Pulmonary involvement is seen in a vast majority of persons affected by the SARS-CoV-2 virus. It varies from mild pneumonia to severe respiratory failure or acute respiratory distress syndrome (ARDS). Hospital mortality of patients with acute hypoxemic respiratory failure reaches 30% and the number of these patients increased dramatically during the COVID-19 pandemic. At the beginning of the COVID-19 era, most of these patients have been transferred to ICU and ventilated invasively. Consequently, intensive care units have faced a shortage of equipment as well as human resources thus clinicians and scientists started to search for new, less invasive, and more convenient treatment strategies. At the beginning of the pandemic non-invasive ventilation (NIV) methods have been poorly described and employed in the management of ARDS because of many controversies. At first, NIV strategies were thought to be associated with a higher risk of virus transmission and for safety reasons were avoided. However, with a separation of high-risk areas and personal protective equipment, the nosocomial spread of coronavirus was reduced. The other NIV-related concern is the generation of large tidal volume which may worsen lung damage and increase the risk for patients to develop self-inflicted lung injury. However, with the appropriate settings, this risk could be minimized, and it should not be a reason to avoid NIV. Over time number of patients affected by novel coronavirus was steadily growing and a new non-invasive approach towards hypoxemic COVID-19 patients has become a core treatment. To date, conventional oxygen therapy, high flow nasal oxygenation (HFNO), and continuous positive airway pressure (CPAP) oxygenation are more and more used in COVID-19 patients. The main goal of these NIV methods is to maintain adequate oxygenation and reduce the need for endotracheal intubation. Despite growing numbers of patients treated non-invasively efficacy and safety of different NIV methods were scarcely described. A clinical review by Crimi and colleagues discusses the advantages and disadvantages of HFNC compared with other NIV methods. The authors emphasize many clinical benefits of HFNC as its early application may reduce the need for tracheal intubation and treatment escalation. They also point out an easy-to-fit HFNC interface and an easier setup. However, only CPAP could maintain positive end-expiratory pressure (PEEP) which is important in COVID-19 affected patients with ARDS. In August 2021, the first results of a clinical trial called RECOVERY-RS were published. RECOVERY-RS is an open-label three-arm randomized controlled trial that has been performed across 48 sites in the UK with the aim to compare the effectiveness of different NIV methods. The biggest non-invasive respiratory support trial compared three commonly used respiratory interventions - CPAP, HFNO therapy, or conventional oxygen therapy. The primary outcome of this trial was mortality and tracheal intubation within 30 days. Over 1200 patients were included in this trial with respiratory failure caused by coronavirus disease. The results of the RECOVERY-RS trial have shown CPAP superiority over conventional oxygen therapy. The need for intubation and mortality was significantly lower in patients receiving CPAP than in those with conventional oxygen therapy (137/377 (36.3%) vs. 158/356 (44.4%), respectively). Interestingly, HFNO has not shown a significant advantage over conventional oxygenation. These findings support the idea that CPAP could be highly effective in the management of patients with COVID-19 pneumonia and acute hypoxemic respiratory failure. RECOVERY-RS trial has several limitations. First, the primary outcome was a quite heterogeneous composite of mortality and tracheal intubation within 30 days. Moreover, the decision to intubate patients was based on a personal physician’s opinion and experience which could obviously lead to biased results. Nevertheless, RECOVERY-RS findings are supported by Sakuraya and his colleagues. They published a meta-analysis of respiratory management in patients with acute hypoxemic respiratory failure. For the very first time, they compared the efficacy of NIV according to ventilation modes with HFNO, conventional oxygen therapy, and invasive mechanical ventilation. The primary outcome of this study was short-term mortality. They have found that CPAP was significantly associated with a lower risk of mortality (risk ratio, 0.55; 95% confidence interval, 0.31 – 0.95). Authors support the idea that CPAP may be the most effective option as the primary non-invasive respiratory management for patients with de novo acute hypoxemic respiratory failure. Several devices could be used to deliver CPAP including helmets. Importantly, helmet-based positive pressure ventilation was significantly associated with a lower risk of death and endotracheal intubation compared with conventional oxygen therapy, HFNO, and face mask NIV among patients with acute respiratory failure in a meta-analysis published in JAMA. Most of the study patients used helmet CPAP therapy and this probably contributed to the superiority of helmet-based ventilation in this meta-analysis. Despite helmet-based ventilation drawbacks, such as large interface volume and dead space it remains an important strategy to deliver CPAP and provide higher levels of PEEP. To sum up, after almost two years of COVID-19 pandemic we still have more questions than answers. Despite a highly effective vaccine against SARS-CoV-2, we are still facing everyday challenges in the management of COVID-19 patients. Respiratory support remains a cornerstone in the treatment strategy with the emphasis on non or less invasive, safe, and effective methods. To date, more and more studies prove the CPAP superiority over other NIV methods in terms of mortality and tracheal intubation. However, further studies are needed to confirm this evidence. Reference: 1. Crimi C, Pierucci P, Renda T, Pisani L, Carlucci A. High-Flow Nasal Cannula and COVID-19: A Clinical Review. Respir Care. Published online September 14, 2022. doi:10.4187/respcare.09056 2. Sakuraya M, Okano H, Masuyama T, Kimata S, Hokari S. Efficacy of Non-Invasive and Invasive Respiratory Managements in Adult Patients with Acute Hypoxaemic Respiratory Failure: A Systematic Review and Network Meta-Analysis. In Review; 2021. doi:10.21203/rs.3.rs-845769/v1 3. Ferreyro BL, Angriman F, Munshi L, et al. Association of Noninvasive Oxygenation Strategies With All-Cause Mortality in Adults With Acute Hypoxemic Respiratory Failure. JAMA. 2020;324(1):1-12. doi:10.1001/jama.2020.9524 4. RECOVERY RS: CPAP vs HFNO vs Conventional Oxygen Therapy in COVID-19. REBEL EM - Emergency Medicine Blog. Published September 13, 2021. Accessed October 25, 2021. https://rebelem.com/recovery-rs-cpap-vs-hfno-vs-conventional-oxygen-therapy-in-covid-19/ 5. JC: Non-invasive ventilation for COVID 19 patients. The Recovery RS trial. St Emlyn’s. St.Emlyn’s. Published August 20, 2021. Accessed October 25, 2021. https://www.stemlynsblog.org/jc-non-invasive-ventilation-for-covid-19-patients-the-recovery-rs-trial-st-emlyns/

12/22/2022 Chicago HelmetBasedVentilation.com serves as a resource to promote this type of technology as an early intervention that can reduce the time and severity of respiratory distress. This work is indebted to the Oregon State University Fast Response Respiration (OFRR) and its team: John Selker PhD, Frank Selker, Mark Johnson PhD, and Ted Selker PhD; and my husband David Lukauskas. “OFRR support for the helmet-based ventilation initiative has enabled us to spread the awareness of this method for treating respiratory distress around the world,” said website co-founder Aurika Savickaite, MSN, RN "thanks to support, encouragement and help from Ted Selker PhD a colleague at OFRR, I was able to continue my work and grow as an expert in this field" Helmet use in the US was proposed when ventilators were in high demand during peak COVID hospitalizations. Helmets interface can be used with BIPAP/CPAP machines or wall gases, saving ventilators for patients who are much sicker. To help the medical community around the world, Savickaite developed a four-hour training course for clinicians to learn how to use helmets. Video from the Helmet-based ventilation training course - Solutions for Ear pressure Savickaite and experts Dr. Bhakti Patel, Dr. John P. Kress, Dr. Jesse Hall, Dr. Maurizio Cereda, and Dr. Giacomo Bellani offered feedback and suggestions to the World Health Organization, which included helmet use for non-invasive positive pressure ventilation (NIPPV) in its 2022 WHO Clinical Care for Severe Acute Respiratory Infection Toolkit. It was the first time WHO addressed helmets in addition to face masks in its recommendations. “This session brought together clinical experts from around the world to discuss the clinical management of critical patients and covered recognition of ARDS (Acute Respiratory Distress Syndrome), use of NIPPV, optimized supportive care, prevention of complications, and patient-centered care,” Savickaite said. A recording of the seminar is available: https://www.who.int/news-room/events/detail/2022/06/21/default-calendar/covid-19-case-management-webinar-series--care-of-the-critical-patient Helmets have been used for more than 20 years in some countries, such as Italy and the UK where they are common in hospitals and ambulances when patients are in respiratory distress. In 2021 Savickaite visited helmet manufacturers DIMAR, Harol, and StarMed, in Italy and this year the world’s largest manufacturer, Intersurgical, in the United Kingdom and its plant in Lithuania. Intersurgical purchased Italian StarMed, and it has encouraged StarMed to grow and improve its helmets. Cooperation with helmet manufacturers, non-governmental organizations, and volunteers resulted in 364 StarMed, 80 US-made Sea-Long, and over 400 Subsalve helmets being sent to multiple hospitals devastated by war in the Lviv and Kharkiv regions of Ukraine. In November 2022, Savickaite presented helmets at ANZICS ’22 (Australia New Zealand Intensive Care Society) conference in Dunedin, NZ. During the trip, Savickaite visited ICUs and met clinicians on-site to share her experience with helmet-based ventilation. She also spent time with the SouthMed team who developed Suzy Hood in NZ. “We also have worked with the Every Breath Counts Coalition, having multiple conversations with them, preparing presentation materials, and presenting together to humanitarian agencies including WHO,” Savickaite said. Every Breath Counts Coalition led by Leith Greenslade is the world’s first public-private partnership to support national governments to end pneumonia deaths by 2030, which has an ambitious goal: to reduce the number of children and adults dying from pneumonia by closing the critical gaps in pneumonia prevention, diagnosis, and treatment. The website, www.helmetbasedventilation.com, continues to raise awareness as Savickaite participates in interviews for podcasts, video recordings, and blogs. An ever-growing audience helps expand the message about helmet-based ventilation, particularly in the United States where helmet use is relatively new. Special thanks to Dr. John P. Kress and Dr. Bhakti Patel from the University of Chicago; Viktorija Trimbel, Finance & Governance expert; Raminta Lilaite, Kristina Skindelytė, and Ieva Mackevičiūtė from Blue Oceans PR. We are incredibly grateful for your time and dedication to help us with our work since day one. Your willingness to offer your expertise and guidance has been invaluable, and we are deeply appreciative of your hard work and generosity. We truly could not have done it without you and we thank you from the bottom of our hearts. We hope you know just how much your contribution has meant to us. "We are always looking for your support and today we need it more than ever to continue our mission. If helmets will not be adopted in our Hospitals - we will have 20-30% more patients on mechanical ventilation" Savickaite said. Continued funding for the www.helmetbasedventilation.com website will allow Savickaite and her team to further spread the message of helmet use around the globe through subscribers and shared information. To learn how to help support this goal, go to: https://www.helmetbasedventilation.com/contact.

December 8, 2022, | Chicago | Infographics #6 by HelmetBasedVentilation.com To learn more about Helmet-Based ventilation - click here.

10/06/2022 Chicago Helmet-based ventilation isn’t a new technology, but how it’s helping innovate patient care in COVID and non-COVID times was the focus of a Medicine For Good podcast. Dr. Julieta Gabiola, a clinical professor of medicine at Stanford University and the president and CEO of ABCs for Global Health, hosts the podcast, Simple Solutions to Medical Challenges: The Wonder That Is Helmet-Based Positive Pressure Ventilation. She interviewed Aurika Savickaite, MSN, RN, co-founder of www.helmetbasedventilation.com, a website aimed at increasing awareness and safe use of helmets to treat patients with severe respiratory illnesses. “Every innovation leads to a new thing, but not every new thing is an innovation,” Gabiola said. “Some innovations are old but may have new creative applications and may even provide practical solutions, for that matter." “Some innovations may be very simple but may have powerful impact or may lead to meaningful outcomes. Helmet-based ventilation is one of these innovations, which offers practical solutions during COVID or non-COVID times,” Gabiola said. Savickaite participated in one of the first studies of helmets in the United States by Bhakti Patel, MD, and to share those positive results with her colleagues and professors she wrote her capstone paper about it back in 2014. “You know, when you come to the US, and you see all this technology that is available in ICUs, all this high-tech equipment that is just so fascinating, I love learning about it. And it was so exciting to be there with the team and to bring more innovation and high-tech. And then one day, when I saw the helmet, I was thinking, ‘Wait for a second, there are no buttons to push, there is nothing super fancy about the helmet. How is that going to work?’ So, helmet looked a little bit funny. Still when I saw the results when I saw these patients who were able to take a breath, rest, and who were able to go over that most difficult stage in their disease when their ventilator was right next to their bed, and we were ready to intubate the patient any moment,” Savickaite said. “It gives you that long-term, non-interrupted noninvasive ventilation or CPAP (continuous positive airway pressure) therapy for the patient,” Savickaite said. “It is very comfortable to wear. Nothing touches patients' faces so they can receive pain-free therapy. “If needed, you can increase the PEEP (positive end-expiratory pressure), wherewith the face mask there are many limitations. If you are using the higher PEEP, you’ll notice air leaks around the face mask, to prevent it - you have to press the mask even harder into the face, and then the skin breakdown will begin,” she said. Helmets offer a universal fit. It doesn’t matter if you have facial hair, trauma to the face, or missing teeth, the helmet fits around the neck with a soft silicone seal that prevents air leaks and improves infection control. The patient can cough, speak, drink, eat, see, hear and have suction and oral care while wearing a helmet. The helmet shouldn’t get clouded or fogged, because the air doesn’t need humidification or to be heated. Helmets help prevent aspiration from emesis because the air is not pushing stomach contents into your lungs. There’s nothing touching the patient’s face to cause anxiety. They fit all sizes, from pediatric to obese patients. It feels like wearing a loose turtleneck, Savickaite said, noting clinicians should try on the helmet first to give confidence to their patients. Savickaite said helmets should be used as the first line of care – not as a last resort. Helmets can be a diagnostic tool, she added. “You will know if a patient is going to do well” within 30 to 60 minutes of starting helmet-based ventilation. “If you don’t see improvement, you might need to have that patient intubated. Don’t delay intubation.” Gabiola noted that helmets have been used in Italy for 20 years, and they worked well during the pandemic. Italy used helmets to help deal with a shortage of ICU rooms and resources, including ventilators and nurses to operate the equipment, Savickaite said. They looked at ways to improve the technology they had to avoid ICU and intubation, even preadmission in the ambulance. “They saw how much patients improved and recovered,” she said. Today, many countries around the world are adopting helmet use. Helmets are two to three times cheaper than face masks, Savickaite said, noting they cost between $125 and $200 per helmet. One helmet can be used for the same patient throughout an entire hospital stay – it doesn’t have to be changed. “If we use helmets now instead of the face mask, we can save $449 million a year in the US. That calculation was done based on the Patel study that was way back before COVID, so I can see that we probably could save even more,” she added. In Italy, clinicians will use one face mask for every three patients using helmets, Savickaite said. “They use the interface every day,” which is why there are a lot of studies about helmets from Italy. One thing to note when reading studies, she said, is that helmet NIV, or noninvasive ventilation, is very different from helmet CPAP. NIV is bi-level ventilation, in which you set up pressure support and PEEP; CPAP provides helmet flow and PEEP. It’s important to know the difference when using helmets, she said. Training is important for anyone new to helmet use to shorten the learning curve and ensure successful NIV with a helmet. She and a team of doctors involved in helmet-based ventilation created a free, four-hour online course to help nurses, respiratory therapists, and hospitalists learn how to use helmets for patients in respiratory distress.

09/16/2022 Chicago Updated 09/26/2022 The 2022 World Health Organization (WHO) Clinical Care for Severe Acute Respiratory Infection Toolkit includes helmet-based therapies, providing valuable information for clinicians who wish to use helmets to treat patients. “It’s exciting to see helmets in the toolkit”, said Aurika Savickaite, MSN, RN, founder of helmetbasedventilation.com. She aimed at raising awareness and safe use of helmets in the treatment of severe respiratory illnesses. Savickaite designed a helmet-based ventilation course, which is now available for free, to help clinicians around the world to use helmets safely and effectively. While developing complete training to ensure the best patient outcomes, Savickaite has worked with experts in the field of helmet-based ventilation since the beginning of the pandemic. The experts include Dr. Bhakti Patel, Dr. John P. Kress, Dr. Jesse Hall, Dr. Maurizio Cereda, and Dr. Giacomo Bellani. Their feedback and suggestions were reflected not just in the training course but also in recommendations for the toolkit to WHO which was introduced at a June 21 webinar. The helmet-based ventilation experts want clinicians to understand the difference between helmet NIV (Non-Invasive Ventilation) and helmet CPAP (Continuous Positive Airway Pressure) therapies, Savickaite said. While both can be used for patients in respiratory distress, they are different treatments, she said. “What is very important to understand is that when the “helmet NIV” term is mentioned in studies - it means that the patient is receiving bilevel ventilation, and you have to set inspiratory and expiratory pressures. Where with helmet CPAP, you’re using CPAP therapy, where you only have to set expiratory pressure and the flow,” she said. Many studies showed that helmet NIV has better patient outcomes in comparison to other interfaces, but the Helmet CPAP therapy success rates are even greater, she said, this is because they are two different therapies for two different patient populations. “What is happening, is that when clinicians read Helmet NIV studies, they assume that researchers used the helmet CPAP therapy,” she said. “We have to pay attention to the details, learn about settings that were used and why these settings were used during the medical trial.” As an example, the Helmet CPAP is used early as a first-line intervention, while helmet NIV is usually used for sicker patients who need more support for ventilation, this is why we cannot compare apples to oranges when we talk about helmets, she added. Mrs. Savickaite and the helmet-based ventilation team warn that if the face-mask specific CPAP or BIPAP settings are used for helmet patients, there will be carbon dioxide (CO2) rebreathing and a failure of noninvasive positive-pressure ventilation (NIPPV). They strongly advise clinicians to have separate instructions for helmet interface which can be found in the training course. Thank you to WHO leaders and clinical experts for including the helmet interface in the new toolkit and spreading awareness about this proven to be safe and advanced technology. Updated 09/26/2022 On September 15th WHO released “Clinical management of COVID-19: living guideline” which includes helmet-based ventilation research studies and recommendations regarding optimal interface for NIV. “The Guideline Development Group (GDG) chose not to make a recommendation regarding optimal interface for CPAP, whether helmet or face mask, given the lack of direct data available for the comparison. The choice between interfaces should be guided by clinician experience, availability, and patent comfort.” I’m so thankful to the team of helmet-based ventilation experts Andrea Coppadoro, Elisabetta Zago, Fabio Pavan, Giuseppe Foti, and Giacomo Bellani for their time and expertise in this field. Their 2021 review article “The use of head helmets to deliver noninvasive ventilatory support: a comprehensive review of technical aspects and clinical findings” is listed as additional information for helmet interface users in the WHO guideline.

02/09/2022 Chicago Helmet-based ventilation offers advantages and benefits for patients and clinicians who use it. Helmetbasedventilation.com website founder Aurika Savickaite shared those advantages and benefits as a guest on Exhale with Vitalograph, a podcast series that explores respiratory care topics. “It’s the only universal device that can allow patients to breathe normally without causing any pain, facial skin ulcers, and necrosis,” Savickaite said, noting patients who use face masks have these issues. “And it also allows you to keep the therapy uninterrupted while still allowing patients to eat and drink. And that can increase better outcomes for these patients.” Some hospitals use helmets for ICU patients who require more than a day of non-invasive ventilation, she said – up to two weeks in Italy, for example. “So you imagine that the comfort for the patient is extremely important during that time because a lot of people will fail non-invasive ventilation due to the interface that is not comfortable,” she said. Savickaite took part in a three-year study at the University of Chicago (published in JAMA in 2016) in which immunocompromised patients with acute respiratory distress syndrome used helmet-based ventilation or face masks. The results found those using helmets were less likely to be intubated, and they spent fewer days in the hospital and ICU. Not every patient can use a face mask but the helmet interface has fewer contraindications. Some people have facial contours that make it difficult to fit a mask, for example, those who have no teeth, who are older, who have facial hair, or who have trauma or burns to the face, she said. Post-op patients can also use helmets. They are especially helpful for obese and overweight patients who will benefit from PEEP (positive end-expiratory pressure). Helmets also can be used to make the transition from the ventilator to extubation much easier, she said. For palliative care or do not intubate patients, helmets provide a comfortable alternative that can be used for a longer period of time, she said. Helmets can be used with patients who have pneumonia or ARDS, but they need to be watched closely, Savickaite warned, “because, as you know, delay in intubation is never a good outcome for anyone. So you always want to watch these patients closely and be ready to intubate if you see any signs of failure.” Clinicians can experience benefits from helmets, too. “Another feature that I love is that you can prevent the spread of infection into the environment. The helmet has a very good seal around the neck, all the air that is leaving the patient is filtered out from the helmet via the HEPA filter,” Savickaite said. “As a nurse who worked at the bedside for many years and saw many patients who use non-invasive ventilation, I also can say that helmets will reduce that workflow for the nurses and respiratory therapists,” Savickaite said. Medical staff are tired and burned out from working long hours, she noted. “If we can do something to help them lower that workload and still reach great outcomes for the patient, that’s a win-win situation.” Link to the podcast: https://exhalewvitalograph.podbean.com/e/episode-14-aurika-savickaite-rn-msn-helmet-based-ventilation-advocate/

01/17/2022 Chicago When Prof. Giacomo Bellani started clinical practice and research, he thought using helmets for patients in respiratory distress was standard practice because they are so common in Italy. After a few years, he realized that outside of Italy, and even in some regions in Italy, no one knew that helmets even existed. Bellani is an associate professor of Anesthesia and Critical Care Medicine of the University of Milan-Bicocca, in Monza, Italy, and a staff physician in the general Intensive Care Unit of San Gerardo Hospital. (Video of the interview is coming soon on our Youtube channel) Helmets are becoming better known, in part because of COVID-19, and in part because of people like Bellani, a proponent for them. He said helmets are “something I really believe works.” A superior tool Helmets are a tool to avoid intubation and, under several aspects, are superior to face masks for most patients, he said. They are part of the workflow – the first line of intervention and a reasonable way to manage patients early. But for patients who respond, helmets used early in treatment offer a longer bridge for other therapies to work. In his hospital, the ratio of patients who use helmets to face mask users is probably 2-3 helmets for 1 face mask. A “helmet is good when you don’t have the possibility to treat patients closely,” he said. “The reason why helmets picked up so much here in Italy, we used to have an outrageously small number of ICU beds,” he said. It forced clinicians to use helmets outside of the ICU in both hospital settings and ambulances. Clinicians who are new to helmets probably don’t know how much easier it is to set up a helmet than a face mask, he added. “Because many times, a face mask is a pain in the neck,” he said. “There are all these leaks and you cannot use it easily with the high flow -- you need a ventilator.” If people used helmets a few times, it would convince them they are really easy to use, he said. Difference between CPAP and NIV People often don’t understand that helmet NIV and helmet CPAP are two very different things. “Helmets are relatively easy to use with CPAP. You just need to have a good flow, and the PEEP valve will do the rest. I think that’s the key point to helmets. You drop the level of nursing assistance ... that you have to provide to the patient,” Bellani said. With CPAP ventilation, you can diagnose if the patient is PEEP responsive. As long as the gas flows, the valve is connected and nothing is disconnected, it’s really hard for something to go wrong with the helmet, he said. It still works, even with leaks. “You know, that’s robust,” he said. “NIV, it’s a different story,” he said. “You need to know how to set the ventilator. And if your goal is really to use it to reduce CO2, because the patient is hypercapnic, that’s not, honestly, as much as I love the helmet, that’s not the direction you want to go.” Bellani also has seen more patients -- even in Italy, the “helmet capital” -- being treated with a high-flow nasal cannula. Bellani helped develop a new Venturi flow generator, the EasyVEE, which allows the size of the port for ambient air to vary and provides continuous modulation of FiO2. He also helped patent a closed-circuit system to recirculate oxygen, remove carbon dioxide and drop oxygen use by 60 to 70 percent. It is able to flush a helmet for CPAP with 60 to 70 liters per minute using only 15 liters of oxygen. Presently, he’s working on a new flow generator, which may be available next year. Few problems with helmets A weakness of helmets, Bellani notes, is monitoring the helmet itself. Patients themselves are monitored, and if the helmet is disconnected from the airflow, there’s an anti-suffocation valve. The good news is that no patients have died from helmet failure to his knowledge. Devices are available now to monitor flow and pressure. The PEEP-Alert, approved by the FDA EUA, measures flow and pressure inside a helmet and sounds an alarm if it drops. Bellani is “very in favor of helmets, but if I was a detractor of helmets, I would see treatises of someone saying that’s too dangerous because you’re putting the patient’s head in a plastic bag, and there’s no alarm.” Bellani suggests doctors and nurses try the helmet themselves. Then, when patients ask, they can honestly say it wasn’t bad. “After they have it on their heads, they see it’s not that bad,” he said. “They breathe better.” Normally, patients find it’s easier to talk and look around. “It’s a little bit noisy (CPAP set up), but besides that, there’s nothing bad in it.” Cost savings for helmet use Many times, Bellani heard criticism that helmets are more expensive than face masks or high-flow nasal cannulas. Studies have shown better patient outcomes with helmet-based ventilation, fewer days in critical care, and less time hospitalized overall. During COVID, many patients in Italy were effectively managed outside of the ICU using helmets, which is a cost-saving that could be measured, he said. Additionally, there’s less nursing time required with a helmet than a face mask. Alberto Lucchini, a nursing coordinator in the general Intensive Care Unit of San Gerardo Hospital, has published papers about the nursing aspects of helmets. Hospitals that don’t use helmets lose the opportunity to start noninvasive ventilation early and to assess the patient to see if he or she is PEEP-responsive. Helmet CPAP can save money because there’s no ventilator, no knobs, no buttons, and no need for a respiratory therapist to be there at all times, Bellani said. “You don’t have to give the feeling that you’re trying to avoid intubation at any cost,” Bellani said. “That is not good either. If you try everything before intubating, you keep postponing the intubation for the patient, which is really bad for the patient.” Helmet use specifics US hospitals don’t have Venturi systems, but they do have a lot of BiPAP machines and ventilators. Helmet CPAP can’t use CPAP mode on a ventilator, though. Most ventilators now allow the use of a flow generator, Bellani said, such as with a high-flow nasal cannula. He suggests using a respiratory branch with a continuous flow system. If that’s not possible, he wouldn’t use CPAP mode, he said. “You have to get some pressure support, and you’re stuck with it. At this point, I would put a relatively low PEEP, let’s say 5, and pressure support of 8- 10, so flow is washing out CO2.” There’s also a problem with the flow that’s too high, he said. While you can go up to 80 to 90 liters for COVID, it’s not necessarily best for the patient, because the pressure is up during expiration. He suggests going to 60 liters. With helmet CPAP, he’s seen cases of self-induced lung injury. He suggests a device from the US, ExSpiron, for noninvasive monitoring of tidal volume. “I was skeptical,” he said, but “it’s very accurate.” Bellani commented on HelmetBasedVentilation.com and its new online course for clinicians, noting this educational offering can help medical professionals understand better how to use helmets for their patients.

11/02/2021 Chicago 05/02/2022 UPDATE - DIMAR CPAP and NIV helmets received FDA EUA approval on April 20th. Helmets for non-invasive ventilation may be new to the United States, but in Italy, manufacturers like DIMAR have been making them for decades. The COVID-19 global pandemic means DIMAR’s helmet production is even more important to the countries and hospitals using these life-saving devices. Company owner Maurizio Borsari has 35 years of experience in the respiratory critical care field. He founded DIMAR in 2002 to produce and market biomedical devices for the treatment of Acute Respiratory Failure, or ARF, and non-invasive ventilation, or NIV, technologies. According to its website, DIMAR supplies about 750 departments in 250 Italian hospitals and 50 national distributors, which serve hundreds of hospitals in Europe and not only. The company has increased production size seven times and will double its laboratory space this fall. Yet, during a tour of the facility, company export manager Riccardo Lambertini noted it’s still a small enough company that many workers do multiple jobs, from research and development to testing and production. Two kinds of helmets DIMAR manufactures two types of helmets: CPAP, which stands for continuous positive airway pressure, and NIV, or non-invasive ventilation (Pressure Support Ventilation and bilevel ventilation). The CPAP helmet has no interaction between patient and machine, Lambertini explained. The airflow runs inside the helmet regardless of what the patient is doing. It’s continuous, and “the patient just takes what he needs from inside the helmet; pressure inside the interface remains stable and diaphragm works physiologically,” he said. The NIV helmet is connected to a ventilator, and as the patient inhales, the ventilator pushes air into the lungs. “If you move to NIV, it is obvious there’s a kind of communication/interaction between the patient and the ventilator,” Lambertini said. The CPAP helmet DIMAR produces is made from flexible biomedical plastic film and has a zipper across the lower front area. It includes a number of connectors to attach oxygenated airflow, a PEEP valve, filters, a manometer, or other devices to measure temperature, pressure, or flow inside the helmet. The neck collar is stretchy and unbreakable but provides a tight seal during use. DIMAR’s NIV helmet is made from stiffer biomedical plastic film with a thicker and more rigid neck collar. It is designed to be less compliant and limit the balloon effect, which you don’t want with a ventilator, Lambertini said. The rigid ring stabilizes the structure and connectors so they don’t move up and down during breathing, which could cause patient-ventilator asynchrony. But where DIMAR has created two helmets – one for each kind of use, CPAP or NIV – the US only has one helmet design approved for use with COVID patients. Lambertini said three things make a helmet a good interface: Patient comfort and easy management for long term treatment Absence of air leaks Dilution of carbon dioxide, or CO2 Comfortable and easy to use Helmets are more comfortable than full-face masks. They have a universal fit so the patient's facial shape is not an issue during helmet-based ventilation because nothing is touching their face. On the other hand, the mask puts lots of pressure on the face and head, which makes long-term use very difficult to maintain. Mr. Borsari demonstrated different pressure points using a water bottle. The same weight distributed in different ways will create more or less pressure. But even a light touch of your finger on your hand after an hour can result in a bruise. DIMAR’s helmets have straps that go under the patient’s arms to help create a good seal around the neck and keep the helmet from rising up or bobbing up and down during breathing. The helmets also have plastic loops at the top to add straps connected to weight to push the helmet down from the top in addition to the underarm straps. It releases pressure from under the arms for long-term helmet users, Lambertini said, offering greater patient comfort. The zipper can be opened by the patient or clinician to allow easy access to eat or put on glasses to read, for example. Even if the helmet needs to stay in place, the connectors allow for a straw to be inserted to get a sip of water, perform oral care or suction. DIMAR also offers a nebulizer attachment that fits the helmet interface. The clear plastic helmet allows the patient to see out all sides, zip opening doesn’t limit the 360° surrounding view. Adding filters to the airflow inlet and outlet protects from pathogenic agent aerosolization and greatly reduces noise in the helmet so patients can hear and speak easily. Patients also can talk while using the helmet, something that’s not possible with a face mask interface. In less than five minutes, Lambertini and a colleague placed a CPAP helmet on Aurika Savickaite to demonstrate how easy it is to use. They checked the helmet, put it on her, and connected it to a venturi system. After a few minutes, Lambertini and Savickaite switched it to wall air and then added oxygen, showing the flexibility of its uses. Removing the helmet also requires two people to stretch the neck collar to the sides and gently take off the patient’s head. But once it’s in place, only one person is needed to adjust the airflow, oxygen, pressures and attach any other accessories. Absence of air leaks Face masks don’t fit perfectly on some people’s faces, which means there are air leaks that can affect the delivery of oxygen and pressure to the patient’s lungs. DIMAR’s helmets are designed to have no air leaks. They are tested by inflating them under 100 centimeters of water pressure to make sure there are no leaks in the interface. This is why the helmet will inflate instantly when connected to the airflow or the ventilator. In a COVID environment, the CPAP helmet isn’t a protective device, Lambertini said, but it is less polluted. Placing a “filter before the PEEP valve can protect the environment from pathogenic agent actualization, which is something really problematic with a high-flow nasal cannula or with a face mask,” he said. Washing out CO2 Patients exhale carbon dioxide, which can cause problems if it’s rebreathed or allowed to build up. “When the helmet was invented, we thought – they thought – the CO2 was higher around the neck or around the head of the patient,” Lambertini said. “So having the connection in this position,” he said as he pointed to his face, “helped the washout. But now we know the CO2 is in this area (bottom) of the helmet, so having the connectors here is better,” he said pointing to his shoulders. DIMAR’s CPAP helmet has more than two connections to separate inspiration and expiration. “It is much easier for the gas flow to enter and leave the interface, and this setup can generate a better washout,” Lambertini said. The additional connector ports are also used to create intentional air leakage to increase the CO2 washout. The volume of a helmet is greater than a face mask, so the patient will inhale more CO2 from a mask than a helmet, in case the airflow is lost, Lambertini said. Because, each minute, 100 to 300 milliliters of CO2 can be diluted faster in a six-liter helmet. There’s no contraindication for using filters, Lambertini added. Just keep in mind that a filter will add 3-4 centimeters of pressure, which will affect the PEEP, or positive end-expiratory pressure, in the helmet CPAP. “If you put the filter in the line with the PEEP valve, the value you set is lower than actual pressure in the helmet. Trust the manometer, not the indication on the PEEP valve” when using a helmet for CPAP setup, he said. Understanding how it works There’s a hesitancy among some clinicians and patients to use helmets. Lambertini said people have been told not to put a plastic bag over their heads, so they are worried about being able to breathe in a plastic helmet. Even some nurses say they would rather use a face mask than a helmet with their patients, he added. Despite the fact that they have never tested it personally, they make assumptions without looking into the physics, design features, testings, and studies that have been conducted on the safety and positive outcomes of using helmets for non-invasive ventilation. “It’s really a matter of being able to explain how it works and why it’s safe. That’s the key point. If you have some doubts, sometimes it’s difficult to make the patient comfortable,” Lambertini said. “This is what we mean when we say that you need to be confident with the machines you are using, with the devices and the interfaces, because when you understand how it works, you can do whatever you want and switch from one device to the other very easily, being confident with what you are doing.” Video:

10/30/2021 Chicago For more than 40 years, Harol has been providing non-invasive ventilation products to help hospital patients. The COVID-19 pandemic increased demand for its helmets dramatically, but the company still struggles to train clinicians about its products and to reach a global market. “(W)e started 20 years ago, talking about using helmets. We know that it works,” said Massimo Callegher, co-owner and production manager at Harol based in Milan, Italy. “We started selling them for hyperbaric therapy, and then some ICU doctor had an idea to use it for ventilation. Harol manufactures 4,000 helmets a year. But during the pandemic, it turned out 16,000 helmets from March through December 2020. “At the beginning of 2020, we had just one machine to manufacture helmets. Now we have three,” Massimo Callegher said. “We started by making less than 50 pieces a day, and now we have a capacity of 150 a day.” “We have completely changed our way of manufacturing the helmet, especially at the beginning of the pandemic, the numbers were dramatic,” he said. Harol offers about 15 products, including face masks and helmets for non-invasive ventilation in various sizes and styles. Confusion is common Despite being the first distributor for the helmet interface, the company still finds some clinicians don’t understand its products or the best way to use them. “With CPAP, when you deliver high flow and the helmet is completely enlarged, you have to make sure you’re providing appropriate CPAP therapy and giving enough airflow to the patient,” said Cristina Callegher, co-owner and sales director. “Sometimes, clinicians don’t understand what we mean - flow generator.” Continuous positive airway pressure, or CPAP, is a type of positive airway pressure that is maintained during inspiration and expiration. Helmet CPAP ventilation uses high flow to achieve results without the use of a ventilator. “They think CPAP is the ventilator mode,” Massimo Callegher added. “Dr. Foti says never connect a helmet to a ventilator in CPAP mode.” (Giuseppe Foti, MD, is director and associate professor at the Emergency Department, ASST Monza, San Gerardo Hospital, Italy, and a researcher in helmet ventilation.) Instead, the helmet becomes the CPAP. If you have a venturi system, you don’t need a machine, just the flow. But there’s a lot of confusion surrounding it. Harol sells a flow generator that helps achieve CPAP therapy with high flow, Cristina Callegher said. “Hospitals buy helmets but not the flow generator,” said Marco Bellati, a product specialist at Harol. Harol’s helmets can be used with a venturi system or connected to medical air and oxygen to create a high flow for patients in respiratory distress. If oxygen is in short supply, the helmet could be used with a high-flow nasal cannula to achieve a higher oxygen concentration for the patient. The bulk of the company’s helmets are sold in Italy where helmet ventilation is more common. Italian hospitals didn’t have dedicated respiratory units like US hospitals. Instead, clinicians in various departments have learned how to administer the therapy. “They started 20 years ago, and now lots of the departments have two or three doctors and nurses dedicated to respiratory therapies,” Massimo Callegher said. It is possible that helmet use will increase after the pandemic as people have time to study them and apply them in successful ways. The COVID pandemic is a stressful environment to work in, and implementing a new device is hard. Some clinicians ordered helmets but never used them because they didn’t know how to. “We face the same problem here,” Massimo Callegher said, noting there’s confusion over a brand name or color change. “You are comfortable with one product. It works. So change is always stressful.” Challenges to helmet use Harol would like to branch out to a global marketplace, particularly the US, but it lacks US Food & Drug Administration, or FDA, approval for its helmets – a lengthy, expensive process for any company to undertake and almost impossible for a small company. Two helmets have been approved for emergency use in the US for COVID patients. Clinicians who wish to use helmets in the US are limited to only COVID patients, or doctors and hospitals can choose to use them “off label.” “I really never understand why in the US” helmets for ventilation have not been approved, Massimo Callegher said. He recalled the former owner of Sea-Long, a US maker of hyperbaric helmets, tried many times to gain approval from the FDA. Helmets face challenges in the US because they are new to many clinicians. Face masks faced the same issues. Doctors were used to intubating patients and were hesitant to use face masks. Over time, their use increased and became regular. As more clinicians use helmets and conduct studies with them, they will become more familiar and regularly used. “We think that the doctor must believe in the product. It’s important,” Cristina Callegher said. “If they can’t trust (it), they give the sensation to the patient. “Usually, patients change their opinion about the helmet when they sense the airflow directly,” she added. “Then, they understand that they can breathe better.” “For us, the US will be an opportunity,” Massimo Callegher said. “The US is a big market for everything.” And helmets are a device that can limit the need for ICU care. “This is the reason why we spread all over the departments in Italian (hospitals) because the cost of stay in the ICU is 10 times the one in a general ward,” Massimo Callegher said. “This is the reason why a lot of physicians try to introduce this type of device.” But because of the pandemic, helmet makers were able to at least put their foot in the door. If US clinicians start to use helmets, everybody else will follow. A face mask interface is about five times cheaper than a helmet, but the results aren’t the same. Helmet use can prevent intubation close to 90 percent of the time in COVID patients. And overall costs to treat the patient are lower with helmet interface, requiring fewer days in the hospital, fewer days in the ICU, and often eliminating the need for intubation and mechanical ventilation. Harol’s helmet manufacturing Harol’s helmets come in a range of sizes and include either an access port at the top or a zipper at the bottom. They can be used with underarm straps or a cushion pillow inside the helmet that helps seat it against the patient’s body. Neck seals are made of polyurethane or silicone. The company doesn’t mold plastic, but it developed the components, which are made elsewhere and assembled onsite. During the pandemic, it wasn’t easy to find people to work, Bellati said. He and Massimo helped assemble helmets every day. “Most of the companies were closed because of the lockdown, but we worked 10 times more,” Massimo Callegher said. They had to train people and increase production. It wasn’t easy, he said, but they did it. “I like to think (the) 20,000 pieces we manufactured last year saved 20,000 lives. Maybe not, but this is my thinking,” Massimo Callegher said.