CompletedNot Applicable

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

United States, Australia, France250 participantsStarted 2024-02-15

Plain-language 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.

Who can participate

Age range

22 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

. Participant is ≥ 22 years of age.
. Participant has been receiving invasive mechanical ventilation for ≥ 24 hours.

Exclusion criteria

. Participant has been receiving invasive mechanical ventilation for \> 96 hours.
. Participant is scheduled or expected to be disconnected from mechanical ventilation ≤ 24 hours after enrollment.
. Participant was intubated for ≥ 24 hours during a prior episode of invasive mechanical ventilation during current hospitalization.
. Participant has a BMI ≥ 40 Kg/m2.
. Participant has no contraction of the abdominal wall muscles in response to abdominal FES as determined by ultrasound.
. Participant has a pre-existing neuromuscular or muscular disorder that could affect the respiratory muscles (e.g., spinal cord injury or Guillain-Barré syndrome).
. Participant has had open abdominal surgery ≤ 4 weeks prior to enrollment.
. Participant has open or damaged skin at area of electrode placements.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Time from first FES treatment administration to successful liberation during the treatment period of 28 days or until ICU discharge, whichever occurs first.

Timeframe: From first FES treatment to 28 days or ICU discharge, whichever occurs first

Trial details

NCT IDNCT05759013

SponsorLiberate Medical

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-02-15

View on ClinicalTrials.gov More Respiration, Artificial trials