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05/24/2021 Chicago Four Italian physicians who have been using helmets for non-invasive ventilation for years share their expertise in a 2.5-hour webinar, recorded May 20, 2021. The experts present their data and share up-to-date, valuable information with viewers. A recording will be available for a limited time. Presenters describe the proper clinical treatment of Acute Respiratory Failure with non-invasive interfaces for adult and pediatric patients in acute and sub-acute departments. According to organizers, the main purpose of the webinar is to develop knowledge and skills related to the timing and ventilation modes of non-invasive interfaces. Topics include: · CPAP: the neverending story · NIV in COVID and non-COVID patients · Helmet NPPV: Tips & Tricks · Role of helmets & masks in pediatric patients · A discussion among participants The webinar shares information about the indications and contraindications for the use of the helmet, the benefits of the new Total Face Mask with ZERO CO2 rebreathing, the best setup of free flow CPAP system, and bedside analysis and optimization of the patient-ventilator interaction during pressure support ventilation with helmet, both for adult and pediatric patients. Helmet use is thoroughly evaluated and compared to other common interfaces for non-invasive ventilation, including clinical effectiveness and patient comfort. Faculty participants are: · Giorgio Conti, A. Gemelli Policlinico, Rome · Claudia Brusasco, Galliera Hospital, Genoa · Roberta Costa, A. Gemelli Policlinico Foundation IRCCS Catholic University of Rome · Giuseppe Foti, San Gerardo Hospital ASST, Monza Link to the Video: https://www.fadstartpromotion.it/nivinterfaces/home/ NOTE: To access the webinar recording you have to register here: https://www.fadstartpromotion.it/nivinterfaces/registrati/ Link to the FAQ page: https://www.fadstartpromotion.it/nivinterfaces/faq/

05/03/2021 Chicago A new device that monitors pressure and airflow during helmet ventilation has been approved for use with COVID-19 patients. The PEEP-Alert Pressure and Flow Monitor received Emergency Use Authorization, or EUA, from the US Food and Drug Administration on April 28, 2021. The new device measures actual airflow and pressure inside a helmet during non-invasive ventilation or NIV. It sounds a loud alarm if the airflow or pressure is too high or too low during patient use. Additionally, if anything is disconnected or occluded, the device will alert clinicians that something is wrong with the helmet setup. The PEEP-Alert monitor was created by PEEP-Alert Technologies, Inc., a team of researchers, engineers, and inventors who work at Oregon State University and the University of British Columbia. They wanted to find a way to ensure proper airflow and pressure levels were maintained in helmets during patient use. PEEP stands for positive end-expiratory pressure. If pressure is too high, it can cause lung injury, but the pressure that’s too low may not be effective. The continuous positive airway pressure, or CPAP, delivered via helmet also needs to provide fresh air to wash out the exhaled carbon dioxide. The new device provides visual and audible alarms if pressure or flow are outside of the parameters set by clinicians. It connects to the helmet outlet and can provide up to four days of continuous monitoring before it needs to be recharged. It is compatible with existing helmets and can be easily disinfected and reused. “This is great news. We have this new accessory for the helmet CPAP setup with alarms. It’s going to be easier for clinicians to monitor patients during the helmet-based ventilation therapy,” said Aurika Savickaite, co-founder of HelmetBasedVentilation.com The PEEP-Alert has been approved for use in Canada as well, and the emergency authorization allows it to be used in other countries. The FDA previously granted EUA for two helmet designs for NIV use. However, because many clinicians aren’t familiar with helmet-based ventilation, they haven’t been used as often. Questions arise about how to set up helmets and use them successfully. Dr. John P. Kress, a professor of medicine and director of the Medical Intensive Care Unit at the University of Chicago Medicine, a not-for-profit academic medical health system, recently shared some tips and best practices for helmet use, including the benefits of PEEP. Kress was part of a study at the University of Chicago, published in 2016, that found patients with acute respiratory distress syndrome, or ARDS, who received helmet-based ventilation had lower mortality rates and fewer days in the hospital than patients who received invasive ventilation with an endotracheal tube.

04/19/2021 Chicago Helmet use to deliver non-invasive ventilation, or NIV, has become more common in the United States because of COVID-19. A University of Chicago pulmonary medical doctor shares tips and suggestions for helmet use to treat patients who have COVID as well as others in respiratory distress. Dr. John P. Kress is a professor of medicine and director of the Medical Intensive Care Unit at the University of Chicago Medicine, a not-for-profit academic medical health system. Kress participated in a University of Chicago study published in 2016 on helmet use in patients with respiratory failure. It showed the benefits of helmet NIV in lowering mortality rates and hospital stays. But the one helmet that they used at that time was not easy to operate, so there was little demand for it, and European helmet manufacturers had no big interest in marketing their product here. Since COVID, the FDA has issued Emergency Use Authorization, or EUA, approval for two helmets to deliver NIV that are easier to use and more comfortable for patients. The new generation helmet neck rings come in many different sizes and doesn’t need to be cut to size. An inflatable pillow goes around the neck to improve the seal. Helmets also have better access to patients’ faces to suction their mouths, give oral fluids, and perform oral care. Like other treatments, as technology advances, the use increases gradually. Back in the 1990s, Kress said, people were skeptical of using BiPAP, a type of ventilation delivered via face mask, because they weren’t familiar with it. There are two ways to use a helmet, Kress said: Connect the helmet to a ventilator and use pressure support mode to deliver bi-level positive airway pressure. Use the helmet to deliver continuous positive airway pressure, or CPAP, by connecting gas flow from the wall, not a ventilator. A helmet used during pressure support ventilation (PSV) can create challenges like patient-ventilator asynchrony, which is different from problems caused when tracheal tubes are used, Kress said. “The helmet has high compliance, and so when the pressure from the ventilator is given during inhalation, what it initially does, is it inflates the helmet and moves the helmet up, with the neck ring being the most compliant part of the helmet. It (air) doesn’t go into the patient’s lungs, because the patient’s lungs are typically much less compliant than the helmet,” Kress said. In a pressure support mode, the ventilator continues to give the pressure until it’s programmed to stop, he said, which for most ventilators is 25 percent of the maximum flow. “That’s a long time when the maximum flow is very high because the helmet is so compliant,” Kress said. Two things have been shown in previous work by other helmet NIV experts to improve the synchrony between the patient, the ventilator, and the helmet, Kress said. Adjust the onset time on the ventilator from the default of 200 milliseconds to 50 milliseconds, which means the breath gets pushed in quicker. Increase the offset time, which is typically a percentage of the maximum flow, from a standard 25 percent or 35 percent to 50 percent. That makes the breath end quicker, Kress said. “That more rapid delivery and short time of inhalation before the breath ends has been shown in previous work – and we did it in our study – to improve synchrony substantially,” Kress said. Additionally, you can reduce the compliance of the helmet a little bit to help with synchrony, he said, by reducing the amount of movement upward. Sometimes the helmet “looks like a bobblehead going up and down,” he said. If you put something on top to hold it in place, the helmet won’t be as compliant, and you see less dyssynchrony. Using straps under the armpits can reduce the tendency of the helmet to bob up and down, he added, and some helmets come with straps on the top of the hood. For patients with hypoxemic respiratory failure, the key to helmet CPAP use is the fresh gas flow of at least 50 liters per minute, Kress said, to make sure you wash out the exhaled carbon dioxide. “What we usually do is just hook the helmet directly up to high-flow nasal cannula apparatus, which can give whatever FIO2 you want, at 60 liters a minute, which will for certain effectively wash out carbon dioxide. Then … you put a PEEP (positive end-expiratory pressure) valve on the expiratory limb.” When it comes time to wean a patient from the positive pressure of the helmet, Kress suggests you can open the front access port of the helmet – new helmet designs have a large access port to reach the patient’s face easily – and put a high-flow nasal cannula on the patient. Disconnect the gas flow from the helmet and hook it up to the high-flow nasal cannula to see if the patient is ready to come off positive pressure. “It buys you a little bit of time when transitioning from one to the other,” Kress said, and it’s much easier than taking off the entire helmet and neck ring. Caution, don’t connect the helmet to the ventilator and set it to CPAP mode. Because if you do that, the patient will rebreathe CO2. Only ventilator high flow modes can be used with the helmet interface. Recent helmet studies of COVID patients found an improved ability to stay off the mechanical ventilation, Kress said. “I think the key thing that makes the helmet different from a high-flow nasal cannula is the need for PEEP,” he said. “One thing interesting was that there has been this description written about, since COVID became such a problem, is the different phenotypes of COVID,” Kress said. One phenotype of COVID is seen with conventional acute respiratory distress syndrome, or ARDS, which is airspace filling, very stiff lungs, and the lungs are amenable to PEEP with recruitments, he said. “But then there’s this other curious group of COVID patients that don’t seem to fall into that biological, physiological category, that is high compliance, … and those patients don’t seem to benefit much from PEEP,” he said. Kress referenced a study by D.L. Grieco and colleagues of COVID patients using helmet NIV vs. high-flow nasal oxygen. The study didn’t make a distinction between the two COVID phenotypes, but overall, there was a benefit for the helmet group with PEEP. “PEEP will improve airspace lung recruitment,” Kress said, but “not everybody with COVID has that.” Helmets are an important component to manage patients, Kress said, particularly COVID patients who have airspace flooding that’s visible on the X-ray. Kress said he had a few patients who were going to be intubated, so they tried the helmet and had remarkable improvement. “You put the helmet on, and the patient’s respiratory rate goes from 40 to 16, their saturation on 100 percent high flow nasal cannula goes from 88 to 97 percent and their FI02 goes from 100 percent to 60, and that happens in 30 minutes. Those are the patients for whom the helmet is most clearly beneficial,” Kress said. But Kress warns to watch the patient carefully. “In the first 30 to 60 minutes (of helmet use), if there isn’t a substantial improvement, you should think twice and identify this person as somebody who isn’t going to benefit,” he said. “I think the biggest error people make, and they make the error with noninvasive mask ventilation, too, BiPAP, is they put the BiPAP on, the patient is clearly not performing well – high energy expenditure with breathing, saturation may be in quotes acceptable, but the patient is failing.” With a helmet or face mask, the patient’s ability to communicate is impaired. You can’t hear them as well, he said, and their saturation may be OK because you’re giving 100 percent oxygen. “But if the patient is working extremely hard to breathe, the saturation is largely irrelevant. And that person needs an advance in the care to perhaps an endotracheal tube,” he said. “Those patients have a very poor prognosis. “Not everybody is going to benefit from the helmet. Some patients will need to be intubated,” Kress said. “In hindsight, some won’t benefit. Some won’t benefit from being intubated. Unfortunately, those people usually die.” Kress has had some patients use a helmet for a week or longer. He also uses sedation from time to time for patients using helmet ventilation. Intubated patients traditionally were routinely sedated the moment you put the endotracheal tube in, which Kress doesn’t think is necessary in some cases but has been practice for many years. “With the helmet, we don’t begin with the idea focused on sedation but rather focused on alleviating the patient’s breathlessness,” he said. If a person is short of breath and distressed, and the helmet improves that, sedation may not be needed. Kress may use dexmedetomidine to alleviate distress, but if it’s not effective, those patients usually aren’t going to tolerate the helmet very well, and it’s risky to use other medications, he noted. Another recent study from A. Sforsa and colleagues showed a small group of patients with hypercapnic cardiopulmonary edema benefited from helmet treatment. Kress agreed that helmets could benefit hypercapnic hypoxemic patients. “If they have both problems, typically the hypercapnia is an epiphenomenon, meaning when your lungs are stiff from airspace flooding, you are going to be more inclined, in all comers, to have trouble. Because when your lungs are stiff and airspace filled, the energy expenditure with breathing is increased. It’s harder to breathe. If your lungs are wet like a sponge, it’s harder to breathe and eliminate carbon dioxide. And so the CO2 rise is usually a reflection not of bronchospasm or things of that sort but rather energy expenditure, because you’re breathing with your lungs being so flooded. And so the ability to eliminate carbon dioxide is impaired. “So it’s not uncommon to see patients with pulmonary edema of any type also have rising CO2, especially when you’re looking at people that are debilitated, weak, or essentially just running out from an endurance standpoint,” Kress said. Helmets sometimes are used for patients with chronic obstructive pulmonary disease, or COPD, as well. However, COPD patients generally benefit so well from BiPAP there isn’t as much positive impact from the helmet, he said. “But the incremental benefit, in my opinion, is driven more from the benefits of PEEP and airspace recruitment, which is, frankly, why, a decade ago, when we first started thinking about the idea of the helmet for ARDS, we chose to target that population because it seemed like they’d be more amenable to benefiting.” Currently, Dr. Bhakti Patel, John Kress, and the team at the University of Chicago Medicine are doing research to evaluate the efficacy of helmet NIV in reducing the duration of invasive mechanical ventilation in order to minimize ventilator needs during the COVID-19 pandemic. Watch a recorded on April 15 2021 video interview with Dr. John P Kress who shared his experience on the use of respiratory assist helmets for reducing the need for invasive mechanical ventilation in COVID-19 patients suffering from ARDS. Video

04/14/2021 Chicago In March 2020, as COVID-19 was declared a global pandemic, a group of volunteers banded together in Canada to create access to medical equipment around the world through open-source design solutions. “When we saw pictures and news articles in Italy, we thought to ourselves, ‘Well, we haven’t seen these methods of helmet-based ventilation in North America. Why is that? And why has Italy been using it widely in managing its COVID-19 patients?’” explained Vionarica Gusti, a team leader on COSMIC Medical’s bubble helmet project. As a result, a non-rigid ring helmet was designed for non-invasive ventilation (NIV). COSMIC Medical, based in Vancouver, BC, is a group of volunteer students and professionals who are committed to open-source design solutions for COVID. COSMIC Medical reached out to Aurika Savickaite, co-founder of HelmetBasedVentilation.com, in April. Savickaite connected with team members for an interview and updates on the helmet project. Gusti and her team had been working on a bag-mask ventilator but switched to a helmet design when they saw them widely used in Italy and read the University of Chicago study which showed lots of benefits of helmet-based NIV for patients with acute respiratory distress syndrome (ARDS). COSMIC Medical volunteers tried several designs but found them challenging because of rigid neck rings that required a large 3D printer or molding to create them. Gusti reached out to DIY Packraft, an inflatable raft maker in rural British Columbia for prototyping advice. The first functional prototypes of a soft neck collar that is heat-sealed to the bubble helmet were connected using a hairstyling flat iron to a plastic hood prototype from SEI Industries, Gusti said. “Helping out with the testing of the non-rigid ring design, I also saw that it was far superior to the rigid ring,” said project co-leader Arpan Grover. “We noticed that because (we were) 3D printing our designs there was a lot of variation in terms of actually clipping the two pieces together, which caused a lot of leakage through the neck seal. We didn’t want that because it was geared toward COVID patients, and we didn’t want aerosols to be leaking from the helmet at all. We wanted to minimize leakage as much as we possibly could.” The soft ring design reduces leakage to close to 2 percent, he said. The new design was simpler and better for the team, Gusti said. They could create prototypes in-house and test them right away. The team settled on biocompatible thermoplastic polyurethane (TPU) to create both the helmet and the neck seal. It needed to be transparent and not have a plastic smell. It’s a little more expensive, Gusti said, but because of the elasticity of the material, it makes a good gasket with whatever port is used. “We also noticed that using the TPU as a neck seal was very comfortable,” Grover said. “It was very easy to get on, as well, and surround the neck, even for four hours, it was very comfortable.” “Because of its very thin TPU, it attaches (to) your neck without constricting it,” Gusti said. The positive pressure of the helmet makes the seal very good, she added. The team plans clinical trials of the helmet and seeks fast-track options to produce it. Large-scale manufacturers with proper certifications are needed to partner with the team and bring the design to where patients need it. Helmets have been approved for use in NIV in Canada and the USA. Additionally, the design is open source for anyone to use. The simple design means it can be produced in other countries, especially developing countries, Savickaite said. Shipping to other countries is cost-prohibitive, Gusti added. Instead, other countries should manufacture their own. She said it costs about $100 (CAN) to produce one helmet. Large-scale manufacturing may bring the price down, she said. Savickaite praised the team and its work. “You have a great helmet design that’s comfortable to use, and you’re sharing it with the world. Amazing.” Video Link to helmet Design Files: https://github.com/COSMIC-medical/bubble-helmet

03/16/2021 Chicago This is a video review of two Harol Hoods for Non-Invasive Ventilation made in Italy. More information provided by the manufacturer here: Helmet Fast-Har and Helmet One-Har More Videos from Harol: Harol helmets are not FDA approved in the US. Other countries can order directly from the manufacturer here.

01/25/2021 Chicago I was delighted to discuss and share my expertise about a helmet NIV with Mr. Ismael Cordero, Senior Project Engineer at Emergency Care Research Institute (ECRI) back in July 2020. Our January 13, 2021, the ECRI team organized and recorded a webcast about NIV helmets. ECRI is the only organization worldwide to conduct independent medical device evaluations, with labs located in North America and Asia Pacific. ECRI is designated an Evidence-based Practice Center by the U.S. Agency for Healthcare Research and Quality and a federally certified Patient Safety Organization by the U.S. Department of Health and Human Services During the webcast, speakers shared their experience and focused on the use of respiratory assist helmets for supplying supplemental oxygen and reducing the need for invasive mechanical ventilation in COVID-19 patients suffering from acute respiratory distress syndrome. Speakers: Andrew Furman, MD, MMM, FACEP, Executive Director, Clinical Excellence, ECRI Bob Kopotic, PhDh, MSN, FAARC, Critical Care Senior Manager, Clinical and Medical Affairs, Edwards Lifesciences, LLC Maurizio Cereda, MD, Associate Professor, Critical Care Anesthesiology and Department of Radiology, Program Director, Adult Critical Care Medicine Fellowship, Co-Director, Surgical ICU, University of Pennsylvania, Perelman School of Medicine Michael J. Frazer, BS, RRT, CPFT, Associate Administrative and Clinical Director Respiratory Therapy and Pulmonary Diagnostics, Hospital of the University of Pennsylvania and Perelman Center for Advanced Medicine Ismael Cordero, BS, Senior Project Engineer, Device Evaluations, ECRI Marc Schlessinger, RRT-NPS, MBA, FACHE, Senior Associate, ASG, ECRI Jason Launders, MS, Director of Operations, Device Evaluations, ECRI ECRI is currently evaluating 4 helmet designs from the U.S. suppliers: Amron, Intersurgical, Sea-Long, and Subsalve. View the session recording, including live Q&A, plus supplementary materials:

10/26/2020 Chicago 06/07/2021: Open-source OxyJet flow-generator design available here. A university faculty and a team of research students have created a low-cost device to provide non-invasive ventilation using a helmet or mask and an oxygen source. The OxyJet nozzle uses jet mixing or the “venturi” effect to pull in environmental air to generate a huge amount of flow. The plastic part can be 3-D printed and connected to a high-pressure oxygen tank using standard connecting equipment. The device works with a snorkel-type or CPAP mask, or a helmet. Dr. Taufiq Hasan teaches in the Department of Biomedical Engineering at Bangladesh University of Engineering and Technology (BUET) in Dhaka, Bangladesh. As the COVID-19 pandemic took hold, they went to work trying to develop a low-cost system that would work in developing countries like their own. Aurika Savickaite, a co-founder of HelmetBasedVentilation.com, interviewed Hasan and his team. “At the beginning of the pandemic, we’ve all seen this situation where everybody was saying there’s a shortage of ventilators,” Hasan said. “We asked ourselves, ‘What can we do? We are biomedical engineers. We need to do something.’” Critically ill patients (about 5 percent of all patients) need invasive mechanical ventilators, but the mortality rate is high for intubated patients, he said. Severely ill COVID-19 patients (14 percent) need a high flow oxygen system or noninvasive ventilators. “These devices are very expensive, and so we wanted to develop low-cost non-invasive ventilators,” Hasan said. The team decided to focus on CPAPs (continuous positive airway pressure) because they could make a bigger impact by reducing ICU admissions, he said. Bangladesh presents unique challenges: Unreliable electric power, cylinders often the only source of oxygen – even in hospitals – and scarcity of medical devices. They tried a couple of designs but realized it needed to be lower cost and simpler. The OxyJet was created. The cost for the system is $50, without the helmet. It provides a high flow with a PEEP (positive end-expiratory pressure) of up to 20 cm H2O. It can offer a maximum flow of 100 LPM, but is optimized at 65 LPM. If you need a really high oxygen concentration, it’s necessary to use two tanks. OxyJet needs no electricity, and it’s very easy to use. The team created a user manual to go with it. Clinical trials are planned at Dhaka Medical College and Hospital (DMCH) in Bangladesh, comparing OxyJet’s high flow with high-flow nasal oxygen, Hasan said. “If that actually is established then … that means you can make huge savings, because our device, overall, it costs around $50, and you can have high flow nasal oxygen devices costing up to $5,000,” Hasan said. When the device is approved, the team plans mass production with the help of an industrial partner. Its low cost could be beneficial in other developing countries, he said. Team members noted the snorkel masks have more air leaks than helmets, but helmets are not readily available and are more expensive. However, helmets reduce aerosolization and are more comfortable, especially for extended wear. The team seeks sponsors and helmet donations. Savickaite noted the “biggest issue that the people, especially in underdeveloped countries, have is to create that high oxygen flow that’s required for helmet ventilation. How to increase oxygen and keep flow at 60L or above per minute, to prevent CO2 rebreathing, that can be challenging,” she said, noting it should be used in a hospital setting. She also suggests the OxyJet could be used when transporting patients by ambulance or in the ER. “If you can put this on the patient early in the disease, early in respiratory distress, you may avoid the progress of this, have fast recovery and the avoidance of intubation,” she said. Hasan and his team are excited, but they wish they had reached this point earlier. “We faced a lot of challenges,” he said. They would order parts, but they weren’t delivered. They didn’t have adequate testing equipment to measure parameters in the lab. “We hope to get this working, no matter how long it takes. But it is what it is. In a developing country, you have different challenges, which are not present in developed ones, especially when you are trying to create something new. So, it took some time,” Hasan said. Savickaite offered praise for OxyJet: “I love it. It’s simple, it’s cheap, and it works!” Video More info about the device: "OxyJet CPAP: Design and Evaluation of a Low-cost Non-Invasive Ventilator for COVID-19 patients" Md Kawsar Ahmed, Meemnur Rashid, Kaisar Ahmed Alman, Farhan Muhib, Saeedur Rahman, and Taufiq Hasan. Department of Biomedical Engineering (BME), Bangladesh University of Engineering and Technology (BUET) Dhaka - 1000, Bangladesh. Email: taufiq@bme.buet.ac.bd Update 06/07/2021: Paper published by the team: OxyJet: Design and Evaluation of A Low-Cost Precision Venturi Based Continuous Positive Airway Pressure (CPAP) System Md. Kawsar Ahmed, Meemnur Rashid, Kaisar Ahmed Alman, Farhan Muhib, Saeedur Rahman, and Taufiq Hasan Open-source OxyJet flow-generator design available here. Update 12/11/2020: Initially, the team wanted to open-source the design but this move will slow the mass-production of the OxyJet in Bangladesh. For that reason, OxyJet is not an open-source design.

11/19/2020 Chicago Helmet based non-invasive ventilation (NIV) study at the New York hospital shows this treatment saves lives among the sickest of COVID-19 patients and adds to a growing list of research. Oxygen hoods demonstrate significant improvement in oxygen saturation and prevent intubation in some people with acute respiratory distress, according to Dr. Owen O’Neill, MD, MPH, FUHM, founding medical director of the Department of Hyperbaric Medicine at Phelps Hospital Northwell Health. “Mechanical ventilation and mortality rates were reduced by about 27 percent by using the hoods,” O’Neill said. “Our study of the hoods was actually begun around the beginning of April (2020) when we had a very high incidence of COVID in the hospital,” O’Neill said. The medical staff got interested in the hoods because they can deliver 100% oxygen without any leaks and reduce the virus spread (helmet NIV creates a closed system). Results of the study, “The use of hyperbaric oxygen hoods as an alternative to conventional high flow oxygen delivery systems during the COVID pandemic,” were shared Nov. 12, 2020, at Associate Council Town Hall. Study author O’Neill is an assistant professor of medicine at New York Medical College and an assistant professor of emergency medicine in the Division of Undersea and Hyperbaric Medicine at Upstate Medical University. He has been practicing the specialty for more than 30 years. He is also the President & CEO of US Hyperbaric Inc., America’s leading commercial diving and tunnel medicine team. This study involved a total of 136 patients; 58 received the hood intervention (Helmet CPAP) and 78 were in a control group. The control group included patients seen prior to hood use, and randomization wasn’t possible since it would be unethical to deny all treatment options to patients. Hoods averted imminent intubation and mechanical ventilation in all patients. For patients about to be intubated, hood use allowed them to avoid or delay the intubation, O’Neill said. The mean improvement in post hood oxygen saturation was 8.8%. Of the 78 in the control group, 37 (47%) needed intubation. Of the 58 who received helmet CPAP, 23 (39.7%) got intubated. “These patients are the sickest ones,” Dr. O’Neil said. “Still, a high percent avoided intubation,” he added. “We achieved a 27 percent risk reduction of the need for intubation,” O’Neill said. “The problem with this was it wasn’t statistically significant. … Although we didn’t reach a level of statistical significance, we did have a 27 percent risk reduction, so you can’t argue with that.” Mortality rates also showed a 27 percent risk reduction. In the control group, 54 of 78 patients died, (69%); 36 of 58 in the hood intervention group died (62%). The goal of any intervention was to save lives. “When we look at intubated patients, they have up to a 97% mortality rate, so we really want to try and do whatever we can to prevent people from needing intubation,” O’Neill said. “By not intubating them right away, we decreased their mortality chances. We also gave them medications that were getting a chance to work.” Helmet aka hood based NIV and mechanical ventilation allow patients recovery time while medications are used to treat the virus. “It’s the bridge,” O’Neill said, giving “time for the patient to recover.” O’Neill said they received positive feedback from some of the survivors. “Of the ones that survived, we had a number of letters back thanking us for keeping them from being intubated. They can remember how uncomfortable they were. And when they got the hood on, they became a bit more comfortable, again enough to hold them over,” he said. O’Neill and hospital staff faced challenges by conducting a study during a pandemic. Hospital leaders were on their side, and one of the benefactor’s daughter provided access to 100 hoods. Staffing in the respiratory department was the most difficult challenge, he said, so the hyperbaric department halted treatment to allow staff to work on the floor and help the respiratory department. O’Neill said it’s important to plan early. “Make the plan and follow your plan. Try and get everyone on board to follow the plan.” He suggests early meetings with pulmonary, critical care, and anesthesia departments. “Break out the data and show them the studies,” O’Neill said. “There’s definitely something pointing to the fact that the hood might be the better route to take.” There’s still more work to be done. O’Neill wants to conduct a prospective randomized trial with other colleagues and hospitals who use the different interfaces for high-flow positive pressure delivery, such as face masks, nasal cannulas, and hoods, and see who does better. If multiple places participate, it would make the study statistically significant, he said. O’Neill said his hospital is meeting to decide where and when oxygen hoods or helmets should fit into hospital policies. “I think they are still looking at using the hoods when patients are getting bad. We’re trying to institute it as primary usage for patients having respiratory difficulty. I’d like to see the hoods used right away,” O’Neill said. Video Congratulations to Dr. Owen J. O'Neill and his team! Their study was published on February 11, 2021, in the Respiratory Medicine journal.

11/19/2020 Chicago This is a video review of the Haven Hood for Non-Invasive Ventilation made in India by Phoenix Medical Systems Helmets are made of medical-grade vinyl, PU, and medical-grade silicone. You can send your inquiry directly to the manufacturer here. Pictures shared by Phoenix Medical Systems: Recent feedback from the clinicians in India: "The Phoenix Haven Hood is the best innovative and remarkable product for covid and non-covid patients who require high PEEP. (eg.ARDS). It helps to protect the patient and caregivers, as it has a facility to filtrate the patient's exhaling air. This haven hood benefiting the patient as more intuitive and less cumbersome." Dr. Ram Kiran, Homi Bhabha Cancer Hospital Research Centre, Visakhapatnam "Haven Hood is a very good device for cooperative patients. It is most useful for moderate COVID symptoms patients. It helps to improve the saturation level for the patients. Also, it is greatly beneficial to caretaker as there is no aerosol dissemination." Dr Vijay Sekhar, Sai Bhaskar Hospital, Guntur "Haven Hood is a very good option for non-critical cases. It is maintaining SpO2 level very well. The patients feel more comfortable to use and they can consume food at any time." Dr. Arif, Medway hospital, Chennai

10/28/2020 Chicago As the United States continues to battle increasing cases of COVID-19, global efforts to fight the virus continues to unite manufacturers and medical personnel worldwide. A CPAP hood that got its start in Italy in 2001 has received the FDA Emergency Use Authorization (EUA) approval for its use in hospitals in the United States. It was a long – and perhaps sometimes bumpy – road to obtain these approvals, but all worth it in the end, according to Marco Finotti, Critical Care Product Manager at Intersurgical Complete Respiratory Systems, a UK-based company. Intersurgical developed the first helmet in 2001 as the available CPAP masks were exceedingly difficult to maintain the seal and uncomfortable for patients. “Italian physicians were looking to solutions to improve the CPAP quality for their patients in the ICU … They reached out to the small company StarMed … So together, with them, we designed the first CPAP hood,” Finotti said. The hood was connected to free flow gases, high flow blenders, and venturi flow drivers. Working with clinicians, they determined what components worked best for the patient and improved the efficacy of CPAP. Meantime from about 2002 to about 2005 clinical studies highlighting the advantages of the interface as well as important technical aspects, helped determine the best use of the new concept product. One example above all was the definition of the minimum flow needed to washout the patient’s expired CO2 from the hood. “Then we were quickly requested to extend the benefits of the hood interface (which are the comfort for the patient, the ability to start the treatment very early and continue for many hours if needed) to the mechanical ventilator,” Finotti said. The question arose: Could the same concept be used for mechanical ventilation in Pressure Support or Bipap ventilation modes? While the basic concept was still applicable, it needed to be tweaked. So, once again working with physicians, they developed a new family of hoods, designed specifically for the purpose of mechanical ventilation. “We learned, step-by-step, that the volume has to be reduced, the compliance of the system has to be reduced, and many other inputs led us to design an optimized hood for ventilation,” Finotti said. The company's Research and Development Team continues to develop new helmet models and accessories to improve hoods that can be used for different medical situations. This includes hoods for CPAP and hoods for use on the mechanical ventilator, “openable” hoods, and hoods with no rigid ring... The challenge was which hood should be presented to the FDA for emergency use authorization. “We did choose the NIV hood for the very simple reason that it’s a smaller design, but if it has to be used for CPAP, when it’s compared to a normal face mask, still has all the benefits of the hood interface compared to masks,” Finotti said. StarMed NIV is somewhat of a multi-use helmet, depending on the need of the patient and the clinician. It has some specific differences. “We are very proud of the material used for the neck seal: we really believe this is one of the big differences between our product and the others,” Finotti said. The material is an extremely thin, plastic film that is not silicon, but exceptionally soft and elastic. It also has biocompatibility that is optimal and is a better material for the application for which it is used. The neck seal has been improved not only for the patients’ compliance but for safety. The hood has an inflatable neck cushion that improves the patient’s comfort and helps to stabilize the interface to achieve optimal mechanical performance. As a result, many clinical studies have proven the effectiveness and great performance of NIV hoods in different patient populations. Even before COVID-19 emerged, the company was working on different helmets and added some improvements that alone took a few months to complete. The flow diffusers were redesigned to generate less noise and improve flow dynamics, the access ports for feeding tubes and catheters were shaped for ensuring optimal seal on various lumen gauges. Two color-coded caps are provided for these accesses to cover all possible catheter options needed for patients of different sizes. “It’s an easy system to apply after you get used to it,” Savickaite said. “We’re going to go through the learning curve here, but with an early application to the patient – on the field, in the ER, on the wards – we can definitely increase the survival rate for these patients and prevent all the complications that may come with the delay of positive pressure ventilation.” Helmets can also be a huge benefit to immune-suppressed patients, she added. Savickaite credited the Italian physicians for their work and research. “I know that everybody is asking for more studies done in the US, but you can always look what the Italian physicians did, who spend so much time and have lots of experience with the helmet ventilation – and they are still using it, so that should be a good product, right?” “In today’s new world, where we are getting used to the new normal, I think the helmet is a great device to prevent the pathogens to spread out and prepare us for more pandemics. The helmet ventilation can actually stop that spread – or at least reduce it,” Savickaite said. About Intersurgical Complete Respiratory Systems: Intersurgical is a global designer, manufacturer, and supplier of a wide range of medical devices for respiratory support. “We provide flexible patient solutions for airway management, anesthesia, critical care, and oxygen & aerosol therapy for use within emergency care, hospitals, and in the home." Video You can send your inquiry directly to the manufacturer here Hands-On Review Video - NIV StarMed CaStar R Hood from Intersurgical Ltd

9/29/2020 Chicago This is a video review of the StarMed CaStar R Hood for Non-Invasive Ventilation made in Italy. The StarMed CaStar R Hood is FDA EUA Approved You can send your inquiry directly to the manufacturer here. More StarMed CaStar R Hood for NIV Product Info A list of studies done with StarMed helmets

09/25/2020 Chicago Now that helmet-based ventilation is becoming more accepted and available throughout the medical communities fighting COVID-19, one company, Charged Concepts, is working on developing accessories to further enhance the capabilities of helmet-based treatments. Charged Concepts, Inc., led by biomedical engineer and CEO Wayne Penn, is a global multidisciplinary research and design firm based in Nashua, New Hampshire. While its past projects range from phone charging systems to educational toys, the company’s main focus – and strength – lies in the medical field. Speakers: Wayne Penn, Charged Concepts; Aurika Savickaite, HelmetBasedVentilation.com; Evan Weinberg, Saigon South International School Educator; Travis Teague, Developer Growth Lead Helium Concepts. The Charged Concepts team features a diverse blend of engineers, physicians, nurses, industrial designers, and regulatory experts who collaborate to identify unmet challenges in the medical field, define their scopes, and develop innovative solutions. The team defines a truly “charged” concept as one that can be transformed into impactful programs, technologies, and initiatives. Since March, the Charged Concepts team has been developing important technologies that will complement and integrate with the helmet-based ventilation system, starting with a monitoring and alarm suite for the helmets. “Alarms play a very big role in a hospital, and are a very important part of the workflow,” said Aurika Savickaite, RN, MSN, and co-founder of HelmetBasedVentilation.com. In both ICU and non-ICU settings, medical teams rely on sensors, audible alarms, and visible alarms to manage and monitor patient care. In the busy environment of a hospital, nurses are mostly caring for more than one patient at a time. Alarms, triggered by sensors monitoring factors such as patient vitals, medication deliveries, and environmental conditions, keep medical personnel aware of the urgency of patient needs and enable faster responses to emergency situations. The monitoring and alarm suite under development by the Charged Concepts team will feature sensors to monitor flow rates, temperature, pressure, humidity, and carbon dioxide levels in the helmets, as well as calculate the fraction of inspired oxygen (FiO2) from air and oxygen mixing. Integrated software will trigger alarms when these conditions move outside of the intended ranges for treatment. Conveniently, the team’s monitoring and alarm suite can be added onto conventionally-available helmet-based ventilation systems without any physical modifications to the helmet. The team aims to create a streamlined tool that can quickly answer critical questions about treatment – What is the pressure inside the helmet? What is the oxygen concentration? Has carbon dioxide concentration reached a level that could be harmful to the patient? – giving the health provider team the information they need to monitor how the treatment is progressing and make better decisions for the patient. “We want to have the computers do the work of monitoring these factors during treatment, so the medical personnel can focus on the care of the patient,” said Charged Concepts team member and educator Evan Weinberg, who teaches engineering and technology at Saigon South International School in Vietnam. As part of his technology curriculum, Weinberg teaches high school students to code simple control systems to trigger lights or buzzers in response to changing conditions monitored by sensors. He hopes that, by securely streaming data from the monitoring and alarm suite to the phone of a nurse or doctor in real time, the Charged Concepts system will enable more efficient and appropriate care. “It’s something that will hopefully make things easier for [all treating COVID-19],” Weinberg said. “We’re looking to build these systems so they are robust and flexible enough to work both now and into the future, as well.” Travis Teague, Developer Growth Lead at Helium Systems, a provider of technologies related to low-power, long-range, encrypted communication between devices on the Internet of Things (IoT), said that their data technology system, “LoRaWAN”, allows for secure data transfer with a highly permeating radio signal for communication across very long distances. “Inside areas like hospitals, where it’s very "noisy" with signals being transferred to and from devices, a lot of times your Wi-Fi – 2.4, 5G – is not going to be as nearly as effective at transferring data as these sub-G bands [Helium’s radio signals], which allow you to have much better coverage [and] a lot better error correction,” Teague said. The technology uses a spread-spectrum-like chirp protocol, which allows users to work in very noisy environments and still have an exceptionally good end-to-end collection of the sensor data, Teague said. The encrypted data from the hospitals can be collected, scrubbed of patient-identifying information, and aggregated to allow others to learn from it. “The end goal is to increasing treatment response speed and efficacy while decreasing oxygen consumption rates and the consequent costs that go along with that,” Penn said, “if we can use [artificial intelligence] machine learning – or allow a nurse or doctor from the nurses’ station to remotely optimize and adjust a patient’s treatment protocol, without even having to go into the room – we can save the 30-60 seconds it would otherwise take for the caregiver to physically reach the patient and start that intervention. Every minute that we save buys the patient a greater chance of recovery and survival.” COVID-19 is an evolving problem, Weinberg said, and everyone needs to work together to get right. “We want to intervene as quickly as possible, [and] make the system intelligent, robust, and secure,” Penn said, “with the technology we’re developing, we can collect a pool of data for future researchers to perform retrospective studies – they can go back and see what worked and what didn’t work.” In addition to the monitoring and alarm suite, the Charged Concept team is developing a proning pillow accessory for the helmet-based ventilation systems. Proning pillows allow a patient receiving a helmet-based treatment to be moved into a prone position on their back or side, without removing the helmet. This positioning allows for improved lung expansion and enhanced expulsion of secretions, which can decrease pulmonary distress and improve breathing. “These accessories are extremely important for the helmet-based systems,” said Aurika Savickaite, RN, MSN, and co-founder of HelmetBasedVentilation.com. Though she acknowledged that her team is still waiting for studies to be finalized and published, she noted that Italian patient data collected early in the pandemic suggested that early proning of COVID-19 patients contributed to higher survival rates and fewer complications. In keeping with the team’s mission to identify and address unmet challenges, Penn emphasized that the accessories under development by the Charged Concepts team aim to “fill in the gaps” in helmet-based treatment protocols. He further stressed that the products are all “helmet-agnostic” and not specific to any one manufacturer’s helmet design. A universal line of products will increase adoption and make the helmet-based ventilation technology more accessible and cost-effective when it is needed most, he believes. The team is currently working to better understand the dorsal (back) lung region and how their proning pillows could allow patients to be positioned to better expel secretions and still be comfortable. They are developing a variety of proning pillow designs, including one that resembles a pair of earmuffs and one that can be inflated and deflated as necessary. They have even designed a pillow that could be moved with an external magnet to allow repositioning by the patient or medical team without removing the helmet. “All the technologies we are developing are designed to make the jobs of the nurses, doctors, and caretakers easier, allowing them to focus more on improving the patient’s care and comfort,” Penn said. “Ultimately, no matter what we do, no cost or amount of money made can replace the life of a loved one, so anything we can do to improve treatments and increase patient survival will be worth the effort,” Penn said. The team at Charged Concepts is pushing on with their development, emphasizing that they are resolved in knowing that the technologies that they are building now will lead to further adoption and advancements in non-invasive helmet based ventilation not only for COVID but for future infectious diseases, as well as have lasting impact in both first world and developing nations where infrastructure, resources, and personnel may be limited. Charged Concepts is currently seeking funding and additional strategic partners to translate the concept demonstrators into commercial products, perform clinical testing, obtain FDA Emergency Use Authorization, and manufacture in volume. Charged Concepts and Helium would like to acknowledge and thank the following organizations for their contributions to this project: Helmet Based Ventilation, SparkFun Electronics, ReSound Clinical and Regulatory Consulting, VFX Lab, Saigon South International School, Integron, Sgnl24, Cantina Films, Companies of Nassal, and NASA. If you would like more information or can help, please contact Charged Concepts at info@chargedconcepts.com Video