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

NCT05759013 · Status: ENROLLING_BY_INVITATION · Phase: NA · Type: INTERVENTIONAL · Enrollment: 272

Last updated 2025-11-12

No results posted yet for this study

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.

Conditions

  • Respiration, Artificial
  • Ventilators, Mechanical

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.

Sponsors & Collaborators

  • United States Department of Defense

    collaborator FED

  • Liberate Medical

    lead INDUSTRY

Principal Investigators

  • Angus Mclachlan, PhD · Liberate Medical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
22 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-02-15
Primary Completion
2025-12-31
Completion
2026-03-31
FDA Device
Yes

Countries

  • United States
  • Australia
  • France
  • Netherlands

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05759013 on ClinicalTrials.gov