Trial Shows Promise in Reducing Ventilation Time in Critically Ill Patients — FDA Grants Emergency Use Authorization to New Muscle Stimulator

A recent trial, conducted by Liberate Medical, found the use of the Ventfree Respirator Muscle Stimulant reduced the overall stay time in hospital for critically ill patients needing ventilation.

Due to the recent pandemic and increased influx of ill patients, hospital ventilators are being pushed to their limit, with some hospitals failing to receive an adequate number of units. This spike in ventilator use is a result of the complications arising from the COVID-19 virus. The virus’s mortality rate is largely attributed to the respiratory failure that results. The need to combat this respiratory failure is important and ventilators have been key in keeping this failure down in critically ill patients. While the ventilators are working to prevent respiratory failure, the duration it takes for a patient to recover is excessive. The influx of patients and the length of ventilator use on a single patient creates a major shortage in ventilators. Sadly, this has forced many hospitals to choose who should or should not receive a ventilator.

The Ventfree respiratory muscle stimulant is Liberate Medicals newest attempt at solving the ventilator crisis. When mechanical ventilation is used, it often causes a disuse atrophy of the major respiratory muscles. This atrophy ultimately can lead to greater complications, making it difficult to wean a patient off the ventilation. A study evaluated 25 critically ill patients on ventilation using Functional electrical stimulation (FES). FES sends electrical pulses to many of the major muscles. Specifically, abdominal FES can improve respiratory function.This study found that administering FES to the abdominal muscles to these patients maintained abdominal muscle thickness and ultimately shortened ICU length of stay.

Liberate Medical funded two randomized trials to determine the effectiveness of their Ventfree system. The VentFree Respiratory Muscle Stimulator uses proprietary non-invasive neuromuscular electrical stimulation to contract the abdominal wall muscles in synchrony with exhalation during mechanical ventilation. In both trials, the Ventfree system was found to decrease the ICU duration of stay and overall ventilation usage. These findings brought forth the FDA breakthrough Device Designation that Ventfree received last year and now Ventfree was just given the Emergency Use Authorization. Due to this new authorization, Liberate Medical has been working with a few United States-based manufacturers to speed up the production in hopes of having the device in the hands of nationwide hospitals immediately.

With this newest use authorization, we can only hope that the Ventfree device can help combat the number of growing deaths caused by the COVID-19 virus. While cases are on the decline and many of the states are beginning to open back up, It may become pivotal having the Ventfree device stationed in hospitals nationwide if a second wave of COVID-19 occurs this fall and winter.

Thank you for reading

Aaron Forsythe LECOM School of Pharmacy