Clinical Research Directory
Browse clinical research sites, groups, and studies.
Pivotal Evaluation of Abdominal Neuromuscular Electrical Stimulation (VentFree) for Weaning From Mechanical Ventilation
Sponsor: Liberate Medical
Summary
The objective of this study is to evaluate the efficacy of the VentFree Respiratory Muscle Stimulator (VentFree) in critically ill adult patients who require invasive mechanical ventilation, when compared to sham.
Official title: A Randomized, Sham Controlled, Double-blinded, Multi-center Trial to Evaluate the Efficacy of the VentFree Respiratory Muscle Stimulator to Assist Ventilator Weaning in Critically Ill Patients
Key Details
Gender
All
Age Range
22 Years - Any
Study Type
INTERVENTIONAL
Enrollment
272
Start Date
2024-02-15
Completion Date
2026-03-31
Last Updated
2025-11-12
Healthy Volunteers
No
Interventions
Breath synchronized abdominal FES
Active abdominal stimulation will be applied for 30 minutes twice per day (minimum of four hours between stimulation sessions), for a minimum of five days per week, for 28 days or ICU discharge, whichever comes first.
Sham breath synchronized abdominal FES
Sham abdominal stimulation will be applied for 30 minutes twice per day (minimum of four hours between stimulation sessions), for a minimum of five days per week, for 28 days or ICU discharge, whichever comes first.
Locations (27)
MemorialCare Long Beach Medical Center
Long Beach, California, United States
University of Florida College of Medicine - Jacksonville
Jacksonville, Florida, United States
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States
Loyola University
Maywood, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
Weill Cornell Medicine / New York Presbyterian Hospital
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
MD Anderson Cancer Center
Houston, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
Memorial Hermann
Houston, Texas, United States
Providence Regional Medical Center
Everett, Washington, United States
Monash Medical Centre
Clayton, Australia
Nepean Hospital
Kingswood, Australia
St. George Hospital
Kogarah, Australia
Prince of Wales Hospital
Randwick, Australia
Royal North Shore Hospital
St Leonards, Australia
Centre Hospitalier Universitaire d'Angers
Angers, France
Hôpital Saint Joseph Saint Luc
Lyon, France
Pitié-Salpêtrière University Hospital
Paris, France
Jeroen Bosch Ziekenhuis (JBZ)
's-Hertogenbosch, Netherlands
Canisius Wilhelmina Ziekenhuis (CWZ)
Nijmegen, Netherlands
Radboud University Medical Center
Nijmegen, Netherlands
Erasmus Medical Center
Rotterdam, Netherlands