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11 results found

  • "Subsalve" Helmet Non-Invasive Ventilation Set-up with safety features

    6/25/2020 Chicago Michael Lombardi of Lombardi Undersea LLC shares his expertise on Subsalve helmet - oxygen-hood NIV respiratory circuits and how to access some safety features through off-the-shelf components. Video Click here to learn more about Michael Lombardi

  • Webinar - Saving Lives Through Non-Invasive Ventilation via a Helmet

    Naeem Lughmani, Michael Lombardi (Subsalve), Emma Macbeath, and Aurika Savickaite.

  • "A gift from the sea" US diving experts designed an NIV Helmet "Oxygen Hood" for COVID patients

    “I’m thrilled this type of treatment is finally being considered seriously in the United States,” Michael Lombardi of Lombardi Undersea LLC., said about the systems. Lombardi also said the Rhode Island State Department of Health toured Lombardi’s manufacturing facility. Lombardi said. Lombardi is already taking orders. This format provides a couple of advantages, Lombardi said.

  • Hands-On Review of an NIV Helmet "Oxygen Hood" from the SUBSALVE USA

    Michael Lombardi in partnership with the Subsalve USA. A video by the manufacturer "Lombardi and Subsalve USA team up to take on the Covid-19 fight with the development and production of an oxygen treatment hood for noninvasive positive pressure ventilation (NIPPV). An interview with the designer of this helmet Michael Lombardi "A gift from the sea" US diving experts designed an NIV Helmet "Oxygen Hood" for COVID patients You can order this helmet directly from the manufacturer here.

  • Hands-On Review of an NIV Helmet "Oxygen Hood" from the SUBSALVE USA

    Michael Lombardi in partnership with the Subsalve USA . A video by the manufacturer "Lombardi and Subsalve USA team up to take on the Covid-19 fight with the development and production of an oxygen treatment hood for noninvasive positive pressure ventilation (NIPPV). An interview with the designer of this helmet Michael Lombardi "A gift from the sea" US diving experts designed an NIV Helmet "Oxygen Hood" for COVID patients You can order this helmet directly from the manufacturer here.

  • BUY a Helmet! Where to get a Helmet? (updated daily)

    At the present time, the Subsalve Oxygen Treatment Hood is the only such device with this specific indication as authorized by the FDA" Michael Lombardi. Updated 08/05/2020 4/9/2020 Lombardi Undersea LLC in partnership with Subsalve USA, both of Rhode Island USA is producing and shipping oxygen treatment hoods. Orders can be placed online or by submitting a PO to Michael Lombardi at michael@lombardiundersea.com.

  • BUY a Helmet! Where to get a Helmet? (updated daily)

    At the present time, the Subsalve Oxygen Treatment Hood is the only such device with this specific indication as authorized by the FDA" Michael Lombardi. Updated 08/05/2020 4/9/2020 Lombardi Undersea LLC in partnership with Subsalve USA, both of Rhode Island USA is producing and shipping oxygen treatment hoods. Orders can be placed online or by submitting a PO to Michael Lombardi at michael@lombardiundersea.com.

  • "Subsalve" Oxygen Treatment Hood Gains FDA Emergency Use Authorization

    08/13/2020 Chicago People diagnosed with COVID-19 -- and the physicians treated them -- have just received another piece of arsenal to fight the virus – the FDA issued Emergency Use Authorization (EUA) for the "Subsalve" noninvasive ventilation helmet. “This is a huge achievement for Michael Lombardy, his team, and the whole helmet industry,” said Aurika Savickaite, cofounder of www.HelmetBasedVentilation.com. “The FDA gave a green light for all the physicians to use the helmet for the COVID patients for noninvasive ventilation in the ICU settings, which is great.” The helmets gained momentum with the onset of COVID-19 early this year, with countries like Italy leading the way and introducing the concept to hospitals, physicians, and manufacturers in the United States. With many advantages over invasive-type ventilation, the helmet gained great interest when able to be used in the right situations for patients fighting COVID-19. Savickaite and her husband, David Lukauskas, started the website with the intention to share information about the noninvasive helmets when the COVID-19 pandemic struck, sharing the stories of physicians throughout the world, helmet manufacturers, and studies regarding helmet use. Savickaite, MSN, RN, was involved in the successful trial of the helmet ventilator in the ICU at the University of Chicago during a three-year study. Advantages of the helmet include faster recovery time, shortening an ICU stay, less need to intubate, lower ICU mortality, minimal or no sedation, and less cost, due to faster recovery, less-invasive treatment, and lower-cost device. However, these advantages were not being optimized, because some were hesitant to use "off-label" the FDA approved helmet, Savickaite said. It was more difficult to gain administrative approval for helmets – and there were some facilities that would not use the devices." Now, with FDA EUA approval, the doors will open more easily, gaining faster approval from administrators, less paperwork, and a safer legal process for the treatment. With faster administrative approval, more clinicians will be able to access the helmets, and more patients can be treated. “Hospitals should feel comfortable using this device and save more lives,” Savickaite said. “I truly believe, this will help more COVID patients, and at the same time, physicians will notice how well (the helmet) works for respiratory distress. In the future helmet can be used for patients who don’t have COVID, but who require non-invasive ventilation,” Savickaite said. For more information on the FDA approval for each helmet, got to the "Buy" page.

  • "Subsalve" Oxygen Treatment Hood Gains FDA Emergency Use Authorization

    08/13/2020 Chicago People diagnosed with COVID-19 -- and the physicians treated them -- have just received another piece of arsenal to fight the virus – the FDA issued Emergency Use Authorization (EUA) for the "Subsalve" noninvasive ventilation helmet. “This is a huge achievement for Michael Lombardy, his team, and the whole helmet industry,” said Aurika Savickaite, cofounder of www.HelmetBasedVentilation.com. “The FDA gave a green light for all the physicians to use the helmet for the COVID patients for noninvasive ventilation in the ICU settings, which is great.” The helmets gained momentum with the onset of COVID-19 early this year, with countries like Italy leading the way and introducing the concept to hospitals, physicians, and manufacturers in the United States. With many advantages over invasive-type ventilation, the helmet gained great interest when able to be used in the right situations for patients fighting COVID-19. Savickaite and her husband, David Lukauskas, started the website with the intention to share information about the noninvasive helmets when the COVID-19 pandemic struck, sharing the stories of physicians throughout the world, helmet manufacturers, and studies regarding helmet use. Savickaite, MSN, RN, was involved in the successful trial of the helmet ventilator in the ICU at the University of Chicago during a three-year study. Advantages of the helmet include faster recovery time, shortening an ICU stay, less need to intubate, lower ICU mortality, minimal or no sedation, and less cost, due to faster recovery, less-invasive treatment, and lower-cost device. However, these advantages were not being optimized, because some were hesitant to use "off-label" the FDA approved helmet, Savickaite said. It was more difficult to gain administrative approval for helmets – and there were some facilities that would not use the devices." Now, with FDA EUA approval, the doors will open more easily, gaining faster approval from administrators, less paperwork, and a safer legal process for the treatment. With faster administrative approval, more clinicians will be able to access the helmets, and more patients can be treated. “Hospitals should feel comfortable using this device and save more lives,” Savickaite said. “I truly believe, this will help more COVID patients, and at the same time, physicians will notice how well (the helmet) works for respiratory distress. In the future helmet can be used for patients who don’t have COVID, but who require non-invasive ventilation,” Savickaite said. For more information on the FDA approval for each helmet, got to the "Buy" page.

  • Professor Antonio Pesenti said "Italy is in the middle of ‘tsunami’ caring for COVID-19 patients"

    3/25/2020 Chicago Italy is in the midst of a “tsunami,” according to Prof. Antonio Pesenti, head of Lombardy intensive-care crisis unit. Pesenti is a professor of Anesthesiology and Intensive Care Medicine at the University of Milan, Italy. Yesterday, Prof. Pesenti spoke to John P. Kress, MD, about the helmet ventilation use during the COVID-19 crisis in Italy. Pesenti had predicted high numbers of patients would require intensive care in hospitals, more than they could handle. He told Dr. Kress that about 20% - 35% of patients improve on noninvasive ventilation (NIV) via the helmet. Prof. Pesenti said that when you apply the helmet, you will see results in one to two hours of helmet ventilation. Physicians will see if a patient needs intubation or is recovering from respiratory distress. According to the International Pulmonologist’s Consensus on COVID-19 guidelines we should not use noninvasive positive pressure for COVID-19 patients to prevent the spread of the virus. However, by using NIV via helmet with an antiviral filter creates a closed system to prevent the virus from passing from the patient to the medical staff. Successful use of helmets in Italy shows they are safe and can be used by US hospitals. Excerpt from: “International Pulmonologist’s Consensus on COVID-19” Chief editors: Dr.Tinku Joseph (India), Dr. Mohammed Ashkan Moslehi (Iran). NIV via helmet regularly is used in Italy but is not common in the US. Helmets were used in one hospital during a three-year study. Dr. Kress co-authored a report of that study of helmet-based ventilation at the University of Chicago Medical Center that found patients recovered faster and were less likely to be intubated compared to those using NIV face masks. The Lombardy region in northern Italy experienced the first cases of COVID-19 in the country and has been the hardest hit in Italy. Dr. Kress is a professor of medicine, specializing in pulmonary medicine and critical care medicine. He is the director of the Medical Intensive Care Unit at the University of Chicago Medicine. He is an advisor for HelmetBasedVentilation.com.

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DISCLAIMER: All research and clinical material published on this website is for informational purposes only. Readers are encouraged to confirm the information contained herein with other sources. Patients and consumers should review the information carefully with their professional health care provider. The information is not intended to replace medical advice offered by physicians. This website will not be liable for any direct, indirect, consequential, special, exemplary, or other damages arising therefrom. 

We share tips and ideas from those using helmets, but these may be off-label and untested ideas and should not be construed as medical advice, FDA approved modifications or proven safe or effective.  Please consider these with caution.

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