The PREVENT trial is a groundbreaking clinical study investigating the VentFree Respiratory Muscle Stimulator’s efficacy in reducing the duration of invasive mechanical ventilation. This pivotal trial aims to support FDA clearance for the VentFree CRESTWOOD device.
VentFree is a non-invasive electrical stimulator that strengthens expiratory muscles and enhances cough effort. It targets patients at risk of prolonged mechanical ventilation in acute respiratory failure. The trial’s success could reduce the risks associated with prolonged ventilation, such as infections and diminished quality of life.
The PREVENT trial follows successful pilot studies in Europe and Australia. VentFree holds FDA Breakthrough Device Designation, Emergency Use Authorization in the US, and CE marking in the EU.
The global trial aims to enroll 272 patients from 25 centers worldwide. Australia, the US, and the EU are actively participating. The first patient enrollments occurred at the Prince of Wales Hospital in Sydney, the Baylor College of Medicine in Houston, and the Providence Regional Medical Center in Everett.
This trial represents a significant milestone for Liberate Medical and critical care innovation. The company expresses gratitude to its partners, the US Department of Defense, and clinical collaborators for their contributions.
Principal investigators emphasize the importance of expiratory muscles in respiratory health and the potential of this trial to revolutionize clinical care for critically ill patients. The PREVENT study aims to provide valuable insights into preventing ventilator-induced complications and improving patient outcomes.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
