By InvitationNot Applicable

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

United States272 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 range22 Years

SexALL

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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.

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 completion2025-12-31

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