Pivotal Evaluation of Abdominal Neuromuscular Electrical Stimulation for Weaning from Mechanical Ventilation (PREVENT)

A Randomized, Sham Controlled, Doubleblinded, Multi-center Trial to Evaluate the
Efficacy of the VentFree Respiratory Muscle Stimulator to Assist Ventilator Weaning in Critically Ill Patients

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Overview
Principal Investigator: Nicholas Hill, MD

This is a randomized, sham controlled, double-blinded multi-center global clinical trial to evaluate exhalation synchronized abdominal functional electrical stimulation (FES) in adult patients receiving, or recently disconnected from, invasive mechanical ventilation to prevent or retard disuse atrophy of the abdominal wall muscles and reduce the number of days of ventilator support. Eligible participants will be randomized 1:1 to the VentFree Respiratory Muscle Stimulator or a sham treatment. FES or sham treatment will be applied as an adjunct to standard of care. Participation will last while patient is in hospital and for up to 3 months afterwards.

Study details
Inclusion Criteria
  • 1. Participant is ≥ greater than or equal to 22 years of age.
  • 2. Participant has been receiving invasive mechanical ventilation for 24 hours but ≤ 72 hours prior to enrollment.
  • 3. Participant or legally authorized representative is willing and able to provide written informed consent.
Exclusion Criteria
  • 1.Participant is scheduled or expected to be disconnected from mechanical ventilation ≤ 24 hours after enrollment.
  • 2. Participant has a BMI 40 or greater.
  • 3. Participant has no contraction of the abdominal wall muscles in response to abdominal FES as determined by ultrasound.
Study Requirements

Length of participation will be about 3-4 months. Participation lasts while patient is in the hospital and for 3 months after he/she has completed study treatment. There is no blood collected or x-rays performed as part of the research.