The trial will examine whether VentFree, a neuromuscular electrical stimulator, can reduce the time acute respiratory failure patients spend on mechanical ventilation.

RT’s Three Key Takeaways:

1. The PREVENT trial aims to demonstrate that the VentFree respiratory muscle stimulator can reduce the duration of invasive mechanical ventilation in patients at risk of being difficult to wean.
2. VentFree is a non-invasive, breath-synchronized neuromuscular electrical stimulator. It has received the FDA’s Breakthrough Device Designation and Emergency Use Authorization in the United States, as well as CE marking in the European Union.
3. The PREVENT trial is a global effort, planning to enroll 272 patients across 25 centers in the United States, the European Union, and Australia, following two successful pilot randomized controlled trials completed in Europe and Australia.

Liberate Medical has begun patient enrollment in the PREVENT trial, a randomized clinical trial aiming to demonstrate that the VentFree respiratory muscle stimulator reduces the duration of invasive mechanical ventilation in acute respiratory failure patients at risk of being difficult to wean.

The VentFree respiratory muscle stimulator is the first and only non-invasive, breath-synchronized, neuromuscular electrical stimulator intended to reduce mechanical ventilation duration by improving expiratory muscle strength and cough. VentFree has US Food and Drug Administration (FDA) Breakthrough Device Designation, FDA Emergency Use Authorization in the United States and CE marking in the European Union.

Reducing the time patients spend on mechanical ventilation should reduce the risks of prolonged mechanical ventilation, including hospital-acquired infections, deteriorated quality of life, and death. 

The company says the PREVENT study will support FDA regulatory clearance of VentFree.

PREVENT Trial Builds on Prior Pilot RCTs

The PREVENT trial follows two successful pilot randomized controlled trials that were completed in Europe and Australia. PREVENT is a global collaborative effort that plans to enroll 272 patients from 25 centers across the United States, the European Union, and Australia.

The Prince of Wales Hospital in Sydney, Australia, enrolled the first patient globally, with the Baylor College of Medicine in Houston, Texas, and Providence Regional Medical Center in Everett, Washington, being the first sites to enroll a patient in the United States.

Supported by $6.5 Million in DOD Funding

The work is being supported by $6,480,942 in grant funding from The Assistant Secretary of Defense for Health Affairs endorsed by the Department of Defense.

“The initiation of patient enrollment in the PREVENT trial is a landmark event for Liberate Medical and innovation in critical care medicine. We are immensely grateful for the support of the US Department of Defense, our team, and our clinical partners across the world for their outstanding contributions to the successful initiation of this important trial,” says Angus McLachlan, CEO of Liberate Medical in a release.

Timothy Girard, MD, MSCI, professor of critical care medicine at the University of Pittsburgh and co-global principal investigator of the study, adds in a release, “The PREVENT trial is poised to provide invaluable insights into prevention of ventilator-induced complications. Our collaborative efforts, supported by the dedication of our participating sites, will potentially improve outcomes for mechanically ventilated ICU patients.”

Photo caption: VentFree

Photo credit: Liberate Medical