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ENROLLING BY INVITATION
NCT05759013
NA

Pivotal Evaluation of Abdominal Neuromuscular Electrical Stimulation (VentFree) for Weaning From Mechanical Ventilation

Sponsor: Liberate Medical

View on ClinicalTrials.gov

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

DEVICE

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.

DEVICE

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