Monitoring Device for Helmet CPAP - FDA EUA Approved
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.