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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, enouragment 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 meet 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.

11/11/2021 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, more 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/

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.

08/26/2021 Chicago Boston doctor encourages innovations like helmet-based ventilation The global COVID pandemic allowed for medical innovations to grow, including the use of helmet interfaces to deliver non-invasive ventilation. That’s thanks, in part, to doctors like Dr. Zaid Altawil, adjunct assistant professor of Emergency Medicine at (Boston University School of Medicine) and an emergency physician at Boston Medical Center, co-founder of hack/ED, a medical hackathon that focuses on innovation in emergency medicine, and founder of an innovation group leading efforts to find technological solutions to COVID pandemic challenges. “It was the perfect opportunity for us to introduce a new technology that is not really commonplace in the United States and have patients benefit from it,” Altawil said. “It was the right-place right-time kind of situation.” Helmets for non-invasive positive pressure ventilation He’s talking about using helmets for non-invasive ventilation to treat COVID patients as the number of infected individuals increased dramatically in spring 2020. “We had already at that point started to do solutions at the hospital. We gave ourselves some good credibility as a group of doctors, nurses that were sort of thinking outside of the box, able to circumvent some of the challenges that were present at the time in order to get out solutions to the patients that needed them,” Altawil said. He received his MD degree from the American University of Beirut and completed his residency in Emergency Medicine at Boston Medical Center in Boston. Prior to residency, he completed a research fellowship in Global Health at Massachusetts General Hospital. He is a strong believer in integrating equitable technological solutions in health care and incorporating design thinking into medical education. “Similar to how other providers faced a similar challenge at the beginning of COVID, there was a feared shortage of ventilators. In some places in the country there was an actual shortage, in others there was more of a feared shortage and a need to sort of plan for that eventual shortage,” he said. “There was a concern, of course, with non-invasive ventilation being a way of aerosolizing infectious particles. And what we saw was that the rates of non-invasive ventilation plummeted drastically. So, we had a double sort of problem. … We had more patients who needed non-invasive ventilation and positive pressure, but at the same time, we had less use because of the worry of the infection risk. It almost quadrupled, in a sense, the issue at hand.” That led to the innovation group looking for ways to solve the problem. Colleagues in Italy were using helmet ventilation, Altawil said. Of course, the urgency of the situation played a part as the pandemic turned a drastic corner where doctors needed to act fast, he added. “For us, we had an intervention that we needed to apply. We had a patient population we knew could benefit from this intervention. We were able to do the background research to see that this is in fact effective elsewhere,” Altawil said. Motivating stakeholders The next step was adding the human factor. “What I mean, you need to be able to motivate a larger group of people to think along the lines you do and understand what motivates them,” he said. He recognized he and his team needed to develop a plan to make everybody’s job easier. Altawil and his innovation team identified primary stakeholders at Boston Medical Center and their needs, then set to work finding solutions. Physicians needed evidence, so Altawil reached out to colleagues at the University of Chicago Medicine who studied helmets in a patient population in 2016. Study author Dr. Bhakti Patel was able to provide the clinical indications and physicians’ protocols, which were put into a packet to tell the Boston doctors how helmet ventilation could help. Respiratory therapists faced a lack of supplies and needed to know how to divide up existing resources. Helmet ventilation decreases the use of critical care ventilators, which helps stretch resources. Nurses provided the most hands-on care to patients and needed to think about how to deliver patient care easily. They also care about their patients and don’t want to see them intubated. Helmets can reduce intubation while still making it easy for nurses to clean, feed, and care for patients. Central processing or sanitation teams are responsible for sanitizing and disinfecting units, so Altawil’s team got in touch with helmet manufacturers to set up protocols to reuse or dispose of helmet equipment. Leadership was very helpful, he said, recognizing the drastic situation and working with providers to explore alternative interventions. Altawil said it helped to have the infection control team on their side. They also had a COVID-specific budget that helped them get supplies quickly, bearing in mind general supply chain issues outside of the hospital. “Without leadership, we wouldn’t have been able to implement it as quickly,” he said. “We had champions in each area, and they’d come together,” Altawil said. They would choose patients where regular non-invasive ventilation with a face mask would have been difficult. Then, they would implement helmet-based NIV and hope others would catch on. It was the hardest part and depended on “word of mouth and having other providers witness you doing it easily,” he said. But it worked, despite the learning curve of a new interface during a global pandemic. “You never know what you don’t know. And I think in that particular instance in our implementation, that learning curve, we did not know as much about that as we needed to be able to tackle it or prepare for it at least,” Altawil said. Future of helmet-based ventilation As COVID sees a renewed resurgence with the delta variant, Altawil envisions broader use of helmet ventilation across the US. Implementation, however, would not be without its challenges. “I think people are very resistant to change anywhere, so there is the mantra of if ‘it’s not broke, don’t fix it.’ And now that face masks can be used again, people might be a bit more resistant to go to something else. I’m talking about hospitals that have not ever implemented helmet ventilation,” he said. “But on the other hand, if all of the data we have on helmets now comes to light and shows a much better intervention, then there is a chance for helmet ventilation to have much broader use.” The University of Chicago study in 2016 showed improved outcomes, he noted. “Now we have a lot more patients of anecdotal, observational data we can borrow from.” While helmets may not be a blanket intervention, they will be a helpful tool to have in the facility for patients for whom a face mask may not work, he said. Seeking solutions to medical challenges Altawil plans to continue seeking solutions for emergency medicine. He helped launch hack/ED in 2019 to address real-world emergency medicine challenges. “How do you find a problem, bring it down to its root, and then bring a solution quickly?” he asked. Nonmedical engineers and design students from 50 universities competed to solve medical challenges. Early in COVID, Altawil helped test and promote adapted snorkel masks for medical providers who didn’t have access to hospital PPE. They were available at no cost through maskson.org. He also worked on setting up IVs outside of rooms to limit how often staff had to change PPE, and they brought monitors to ventilators that didn’t have them. “All of the work that we’re doing now was inspired by that early work in global health,” Altawil said. “You have this idea that the United States is the peak of technology, and everything is greatly available, but sometimes, that’s not the case. We noticed that with our work in the global health field that sometimes the simplest things can have the greatest impact. So we need to combine both of these worlds. “I think people are catching on to the idea that things in medicine do not have to be very slow, and we can do things fast but also safely,” he said. Aurika Savickaite, MSN, RN, founder of HelmetBasedVentilation.com agreed, noting this was evident during the pandemic. “I believe the main lesson is if it’s simple technology, and if it can make your job simpler, it’s sold,” she said. Helmets fit squarely into that category of providing a simple technology that benefits patients and is cost-effective, she said. Video

08/10/2021 Vilnius, Lithuania The synergy between data science and medical knowledge changes the traditional approach towards patients who need mechanical ventilation. Information technology (IT) specialists using the latest data processing technologies provide medical personnel with new possibilities for decisions making and patients’ monitoring. A Lithuanian based company Acrux Cyber Service with the help of critical care specialists from the Republic Vilnius University Hospital has developed a novel system where all the data from sensors of the ventilator are collected and analyzed using various algorithms in order to adapt ventilation to individual needs as much as possible and ensure maximum safety and quality of mechanical lung ventilation. The new generation ventilators provide and display an enormous amount of real-time data for each breathing cycle. For a long time, all this information was used to a limited extent because the data collection, storage, and analysis was a complex and resource-intensive process. Devices for centralized management are quite expensive and have their own shortcomings in the data processing. Luckily, rapidly evolving data science using artificial intelligence technologies has found a way to process information and create an innovative system, where medical personnel are able to monitor the settings and parameters of each ventilated patient. This system uses machine learning algorithms to automatically detect errors, patient-ventilator asynchronies, and other discrepancies between the patient and the device and warns the hospital staff. Moreover, the system employs various predictive analytics methods to offer the most suitable lung ventilation technique for each patient. We talked about this novel system with one of the innovators Dr. Saulius Vosylius, a professor of medicine at Vilnius University and Head of the Center of Anesthesiology and Critical Care Medicine in the Republic of Vilnius University Hospital. Dr. Saulius Vosylius has over 30 years of experience in intensive care with his special interests in mechanical ventilation. “At the very beginning, the medical team decided which type and method of lung ventilation is the best for each patient. The initial parameters – volume or pressure, flow, frequency, oxygen fraction (FiO2), etc. are set by the physician. After setting up the device, a lot of data is generated by the ventilator itself. The problem is with data storage and processing because an enormous amount of data is provided during each inspiration and exhalation which is hard to process for medical staff. Of course, devices for centralized management of patient data exist but with a number of limitations.” Here, a solution was proposed by IT specialists. They came up with an idea to collect the data directly from the devices and send it to the server via a safe wireless connection. There the data is filtered and analyzed using various data science methods, including machine learning algorithms. Either real-time or summarized data could be accessed from the connected personal device – tablet, mobile phone, or laptop. It is important to note, that the data is completely depersonalized. The application does not store any personal information, yet the attending physician is able to fill in data on the dynamics of the patient’s health. Using this platform, the medical personnel can remotely monitor the parameters of ventilation of each patient in real-time or take a look at the summary report for certain period of time. The generated report shows how long the patient has been in the therapeutic range of ventilation, how often, and what type of asynchronies have occurred. Moreover, the system itself is able to detect discrepancies and trends in certain parameters which could be related to changing patient’s conditions. These features not only facilitate the work of medical specialists but also ensures maximum safety for patients. As Dr. Saulius Vosylius said, the biggest challenge during the ventilation process is ventilation-induced lung injury (VILI) so the risk for the development of VILI should be minimized. „If the airflow pressure is too high, the air is blown too quickly or there are discrepancies between patient respiratory forces and ventilator (so-called patient-ventilator asynchrony), the risk for VILI increases. The main goal of our project was to create a data analysis system which could detect early changes in ventilation parameters related to lung injury, find out the causes and suggest solutions to prevent VILI“, said the professor. The created system uses machine learning algorithms to recognize all irregular or incorrect respiratory cycles (e.g., the patient tries to inhale and the machine does not respond). In addition, these are not only recognized but the probable causes are provided when known (e.g. leak or excessive activity of the patient). During volume and pressure control ventilation it is also possible to calculate mechanical power, related to the risk of VILI. „An innovative artificial intelligence-based system, which is capable to process and analyze hundreds and thousands of different parameters of ventilated patients and provide the medical staff with the warnings and recommendations, is indispensable in intensive care units. Our system can warn staff about the changes in the ventilation process and make suggestions for ventilation methodology trying to adapt settings for individual needs. The early detection of deteriorating respiratory function enables us to make changes of ventilation settings for the best quality and the optimal treatment results“, said Dr. Saulius Vosylius. The professor believes that the current system could also be used to reduce human errors when irregular or incorrect respiratory cycles remain unnoticed. This would also be very useful for the less experienced medical workers or junior staff because ventilation parameters can be monitored remotely by the expert and useful recommendations are provided by the system itself. The software does not take on the decision-making function, but it provides the data which helps to make the best decision. „Mechanical lung ventilation is often seen as a method, but we should keep in mind that lung ventilation is a process that requires not only medical knowledge but also continuous monitoring and analysis of the ventilation parameters. We must assess the quality of the ventilation process in order to reduce hospital’s financial burden and save our human resources“, the professor noted. To date, the current system is being tested with invasive mechanical lung ventilation, but it is expected to also adapt algorithms for non-invasive lung ventilation methods to optimize non-invasive lung ventilation capabilities in the very near future. Dr. Jokūbas Drazdas, co-founder of Acrux Cyber Service is glad that the cooperation of data specialists and physicians has managed to create a unique and innovative system to facilitate the work of medical staff as well as maximize patients‘ safety. The new system is being tested in the Republic Vilnius University Hospital, where data from lung ventilation devices are analyzed and processed continuously. The developers emphasize the importance to involve more medical centers for wider recognition of the software. Acrux Cyber Service has started the process of certification of an innovative system in the EU, which is expected to expand the possibilities of using the system in Europe.

06/23/2021 Chicago Panicked by the global pandemic in early 2020, some Brazilian researchers found a way to help patients living in their state when they developed and brought to market a helmet design for non-invasive ventilation. Herbert Lima Santos da Rocha, an industrial designer since 2000, professor at University of Fortaleza (Unifor), and co-coordinator of lab research and innovation related to cities, teamed with others on a video call to talk about what they could do. News reports from Italy about COVID patients were grim. “We were expecting something bad,” Santos da Rocha said. “By what we were seeing in Italy, we were expecting something very bad.” During that initial meeting, they decided: “Let’s do something that would ease (the) impact on society.” First, they considered mechanical ventilators, but they faced an obstacle: Many of the companies and suppliers, such as those in China that they needed to rely on, were closed. By their second meeting, the team had landed on the idea of a helmet, like the ones used on old diving suits. They thought it was interesting that a patient could breathe oxygenated air, Santos da Rocha said. A team member, the pulmonologist Dr. Marcelo Alcantara, had worked with transparent helmets years before – an Italian model – to treat other lung diseases and suggested it could be used for COVID. The team agreed to pursue buying helmets, but that was impossible. The demand was so high, they never even got a call back from the manufacturers. At their next meeting, the team decided: Let’s make one. And so began the creation of Elmo, an assisted breathing helmet for patients with mild to moderate breathing issues. The team, based in the Brazilian state of Ceará, still faced the issue of not being able to get parts from other countries or even other states in their country. Instead, they decided to make the device using locally sourced supplies. “That was one of our first directives of our product. We need to find a solution to make it in our house,” Santos da Rocha said. The project was a joint effort between the University of Fortaleza (Unifor), the Federal University of Ceará (UFC), the Federation of Industries of the State of Ceará (Fiec), National Service for Industrial Training (Senai), and the Government of the State of Ceará, through the Secretariat of Health of Ceará (Sesa), the Public Health School of Ceará (ESP) and the Cearense Foundation for Scientific and Technological Development Support (Funcap). Injected, moldable plastic can be complicated and expensive. Even to make a mold would take months, Santos da Rocha said. They needed an efficient solution and came up with a simple two-ring design with a silicone neck seal. The design was easy to make into a mold and easy to produce 1,000 units, he said. Everybody was working at home at that time, Santos da Rocha said. He’d built a small home lab but didn’t have access to materials. He called a local store to buy a sheet of transparent PVC, picked it up, brought it home, and made the first version of the helmet using scissors and hot iron to weld the borders. As prototypes were tested, Esmaltec, a company in Ceará that makes refrigerators and stoves, was getting set up to produce the medical devices. The company has the machines and knowledge of the industrial process as well as “very good minds working there,” Santos da Rocha said. By 23 of June 2020, the helmets were being used on sick patients. One of the first was a woman aged 77 with oxygen saturation of about 90 percent, during the treatment with a face mask. After a few minutes of using a helmet, her saturation increased to 96 percent. During their months of production, they’d heard of other universities doing similar COVID work, even developing helmets, but they never were produced, Santos da Rocha said. “Many universities are used to research and publication,” he said, producing one unit to show the results. “But to make the product possible to be mass-produced, and finally be able to have a thousand units on the market, you don’t see that in university classes.” The other universities never reached the point of production, he said. “We had a team of people to make products for (the) market. “During research, tests, we were already contacting the government agencies with documentation to get the license to allow (us) to make the product,” he said. Esmaltec was doing its part to get ready for the production of a medical device. The prototype was simple, but “to deliver thousands of seals and thousands of hoods, all of that takes time.” Today, the company is able to produce around 500 units a day, and 9,000 helmets have already been delivered to hospitals, he said. The clinical trial results are excellent but not yet published, Santos da Rocha said. “Fifty to 60 percent of (COVID) patients that normally would be intubated, they got the helmet, and they recovered without needing to be intubated,” he said. Response from clinicians was excellent, as well, he said. The team prepared materials to train medical teams and show them the possibilities for using Elmo. Santos da Rocha listened in at a meeting a couple of months ago when physicians in Ceará related patient success stories about the helmets that nearly made him cry. “They (patients) were able to take a bath. Before that they were bedbound. They couldn’t do anything. Now they were able to take a bath,” he said. Patients who finished treatment posted videos on Instagram. “No one asked them to do this,” he added. “We heard a story a few weeks ago that was very interesting, touching,” Santos da Rocha said. A morbidly obese patient with COVID needed to be transported via ambulance from his home in the south of the state. He was very ill, Santos da Rocha said. Ceará is a large state, and the trip would take four or five hours. “They placed the helmet on him, and he made the whole trip from his small city to the capital by ambulance wearing the helmet,” he said. “We designed something thinking to use (it) inside hospitals,” but it also works in other conditions. “That’s great!” he said. Elmo is intentionally designed to have a smaller volume of 20L inflated to help with flow and reduce rebreathing CO2, Santos da Rocha said. Two tubes connect to wall air and oxygen provide 30L per minute per each tube. An antibacterial filter adds about 2 to 3 cm of water. At setup, clinicians use a manometer to test pressure inside the helmet. Manual flows, including a mixture of air and oxygen, are 40, 45, 50, 55, and 60, depending on the patient, he said. In some prototypes, they noticed that CO2 was higher. “If we placed the outflow of the helmet higher, the CO2 is heavier, the patient would breathe CO2 (more),” Santos da Rocha said, noting he’s seen many helmet designs around the world where he’s sure the patient is breathing CO2 because of this design flaw. NAZAreno Júnior [@nazarenojr_]. (2021, April 29). EMPATIA sendo exercitada na prática! O capacete Elmo é uma criação cearense! Ele ajuda muito no tratamento da Covid19, contribuindo. Instagram. https://www.instagram.com/p/COQYTmphmyC/ Some patients need a higher flow and higher oxygen supplementation. In cases where oxygen is in short supply, the nasal cannula can be used inside a helmet to provide oxygen while creating flow with just medical air. “We tried to find some solutions that would lower the oxygen consumption,” Santos da Rocha said, but they wanted to make the helmet available as soon as possible. “The project could have taken more months if we went to find solutions to small problems that we knew were there, but we needed to make this product available.” In December 2020, Brazil was at the beginning of the second wave, with the recording of 750 COVID deaths a day. During the apex of the second wave a month ago, it was surpassing 3,200 COVID deaths per day. “We’re working now at this exact moment, we have another team, working on a better version of the helmet, different materials for the membrane,” he said. The goal is to make it at a lower cost and to last longer. Helmets can be cleaned and used for four to five patients before they start to degrade. Additionally, they are considering accessories for the helmet, such as a manometer to track breathing frequency and pressures. A new accessory will replace the PEEP valve to regulate outside flux and control internal pressure in the helmet, Santos da Rocha said. It will be cheaper than a PEEP valve, costing cents of a dollar. The plan is for the design to be done in October, he said. The new design team involves students, as well. During the initial design process, Santos da Rocha shared weekly updates with his students. Coincidentally, they were learning about creating equipment for people with disabilities. He could tell them in real-time about the equipment they actually planned to produce. “Usually, you don’t have this kind of richness of information. Usually, a professor creates a problem for them to solve. In this case, it was a real problem appearing,” he said. “Some contacted me months after when it appeared in (the) media.” “That one?” they’d ask. “Yes, that one,” he’d reply. Pictures: NAZAreno Júnior [@nazarenojr_]. (2021, April 29). EMPATIA sendo exercitada na prática! O capacete Elmo é uma criação cearense! Ele ajuda muito no tratamento da Covid19, contribuindo. Instagram. https://www.instagram.com/p/COQYTmphmyC/ Herbert Lima Santos da Rocha (2020). Home photography