Updated: A Helmet-Based Ventilator Alternative for COVID-19 Patients
Original publication date: April 30, 2020
Update: On August 6, 2020, the FDA issued an Emergency Use Authorization (EUA) for the Subsalve Oxygen Treatment Hood. It is the only helmet-based ventilator to be FDA approved and the first to be approved for COVID-19 related respiratory distress. Previously, it has been used off-label. More than 20,000 hoods have been distributed internationally over the past few months.
Many people have sprung into action during this coronavirus pandemic, offering their expertise and helping in any way they can. That is just what Aurika Savickaite, RN, MSN, her husband David Lukauskas, and his sister Viktorija Trimbel did from their home in Chicago in mid-March.
Aurika worked as an ICU nurse and patient care manager at the University of Chicago Medicine for 10 years. She is an expert in non-invasive ventilation (NIV), which supports a patient’s breathing and provides ventilation without using an invasive artificial airway tube placed via intubation.
While talking with David at the kitchen table, Aurika noticed that helmet NIV would be extremely helpful for coronavirus disease 2019 (COVID-19) patients, the disease caused by the novel coronavirus. To help spread word about NIV, they launched the Helmet Based Ventilator initiative, a website that compiles information about helmet-based NIV for healthcare professionals.
Non-invasive ventilation (NIV)
NIV can be administered via face mask, which fits over the mouth and nose, or via transparent plastic helmet, which goes over a patient’s head and seals around the neck. The helmet provides a pressurized system of oxygen-enriched air to help the patient breathe. Compared to invasive mechanical ventilators that require intubation, NIV allows patients to be more comfortable, as they can remain awake and do not require sedation. Because patients are awake, NIV also reduces the workload on healthcare workers who take care of them (taking care of cognizant patients is less burdensome than taking care of sedated patients).
In addition to the mechanical ventilator shortage due to the coronavirus pandemic, there is currently another critical shortage – the shortage of sedatives, drugs that are constantly needed while patients are using mechanical ventilators. The U.S. Food and Drug Administration (FDA) is currently reporting multiple sedative shortages, including the common sedatives midazolam and propofol.
“If you say we need ventilators and not … the drugs to make them go, we’re going to have a ton of ventilators sitting around not being used,” Dan Kistner, PharmD, Group Senior Vice President at the healthcare performance improvement company Vizient, told Vox. “It’s like having a car without gas.”
This is where non-invasive ventilation can step in – by not needing patients to be sedated, using NIV removes the need for sedatives in the first place.
Helmet Based Ventilator initiative
BioSpace spoke to Aurika to learn more about the Helmet Based Ventilator initiative, NIV helmets, and how they can be used during this coronavirus pandemic.
Any text in italics was added for clarity and more information.
What made you start the Helmet Based Ventilator initiative?
Aurika: “I worked with patients during a clinical study where we tested the helmet ventilator in the ICU at the University of Chicago. My final capstone paper for my Nurse Practitioner degree was about the study.”
Can you talk about what the Helmet Based Ventilator initiative has done so far?
Aurika: “With the help of the AmbiFi team, we developed the Interactive Smart Procedure - Protocols and Guidelines about Helmet Ventilation (NIV) from the University of Chicago Medicine. It is a free tool that is available now in English and Spanish and will be translated into more languages. It has narrated step-by-step instructions, critical checklists, patient triage, helmet setup, patient helmet placement, monitoring, and weaning instructions.”
This tool is also available via the AmbiFi mobile app. Download ‘AmbiFi’ on the Apple App Store or the Google Play Store, then log in with the following credentials to access the Helmet Ventilation Smart Procedure: Username: covid19, Password: Covid19!
The Helmet Based Ventilator website includes many articles written for a variety of audiences, such as doctors, manufacturers, helmet suppliers, and funders. Content includes medical guidelines about NIV administration, hands-on review videos that show helmet ventilators from different manufacturers, helmet NIV infographics, and other news coverage about NIV.
How do helmet-based ventilators work?
Aurika: “The helmet is used for non-invasive positive pressure ventilation (NPPV). NPPV via helmet is known and used in Europe, especially Italy. Helmet NPPV works like NPPV via facemask but is better tolerated by the patient and has minimal-to-no air leakage.”
Dr. John P. Kress, MD, advisor of the Helmet Based Ventilator initiative, shows how helmet ventilators work in this video. Dr. Bhakti Patel, MD explains the best practices for helmet ventilation in this video tutorial.
Can any hospital use helmet-based ventilators? What equipment does a hospital need to run the helmet?
Aurika: “The hospital must have a reliable fresh gas flow. You can do that one of three ways: with a ventilator set to pressure support mode, a BiPAP V60, or a fresh gas flow off the wall. The pressure is created by the gas flow and peep valve. The seal around the neck has minimal-to-no air leakage.”
The infographic below shows how helmet ventilators are hooked up.
How does a helmet ventilator compare to an oxygen face mask?
Aurika: “Our study (published in JAMA in 2016) showed a dramatic reduction in the intubation rate of acute respiratory distress syndrome (ARDS) patients using a helmet ventilator compared to oxygen face masks. There is more research from Italy supporting these findings.”
In this video overview of the 2016 clinical study, Dr. Patel said that “helmet ventilation reduced the chances of needing a ventilator from 60 percent to 20 percent. If we treat five patients with ARDS with the helmet, we can prevent one death.”
Why are helmet ventilators important, especially during this COVID-19 pandemic?
Aurika: “Helmet ventilation is better tolerated by the patient and prevents virus aerosolization – it saves lives and resources. For COVID-19 specifically, 20-30 percent of COVID-19 patients who received helmet ventilation avoided intubation, according to feedback from Italian doctors. Avoiding intubation is especially important for COVID-19 patients because 80 percent of intubated COVID-19 patients die.”
A clinical study from Wuhan published in The Lancet Respiratory Medicine showed that 19 of the 22 ICU COVID-19 patients who were intubated died (86 percent). According to the Associated Press, New York City officials say that 80 percent of intubated COVID-19 patients have died.
What are the advantages of helmet ventilators?
Aurika: “It is a simple design and helmets can be produced in large quantities. It is easy to use – the simple helmet-based NIV procedure can be learned quickly by clinicians. Helmets are inexpensive, only costing about $150 per helmet (ranging from $125-280). Patients can move around and be prone while using the helmet. Also, you don’t have to take it off if the patient needs to have oral liquids or suction.”
What about the limitations of helmet ventilators?
Aurika: “It is noisy for the patient – they have to use earplugs or headphones. It can also create pressure on the armpits or the neck, but we have tips on how to minimize these issues. Skin necrosis, gastric distension, or eye irritation are occasionally observed during helmet NIV, while these may be results of long-term treatments with face masks.”
Where are COVID-19 patients currently being treated using the helmet ventilator?
Aurika: “US hospitals are ordering and using helmets for COVID-19 patients as we speak. According to a recent Wall Street Journal article, helmets are currently being used on COVID-19 patients at the University of Chicago Medicine and the Hospital of the University of Pennsylvania. Massachusetts General Hospital has also ordered helmets.”
Check out the article on HelmetBasedVentilator.com to learn more about US hospitals using helmet ventilators.
How can a healthcare professional get a helmet ventilator?
Aurika: “To purchase a helmet ventilator, please contact a manufacturer directly. We have four US-based manufacturers listed on our website: Sea-Long Medical Systems, Amron International, Extol, and Lombardi Undersea in partnership with Subsalve USA. Virgin Galactic is another manufacturer not listed on our website yet because they are still testing their helmet. We regularly provide updates about helmet ventilator suppliers and manufacturers.”