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

Completed · Not applicable · Has a placebo group

Conditions studied: Respiration, Artificial, Ventilators, Mechanical

In brief

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.

Key facts

Study ID

NCT05759013

Run by

Liberate Medical

People needed

250

Starts

2024-02-15

Expected to finish

2026-05-01

Last updated by the study team

2026-06-02

Who can join

Age: 22 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

• 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.
• Participant has a pacemaker and/or implanted electronic device.
• Participant is known or expected to be pregnant. NOTE: A negative urine or blood pregnancy test will be documented during screening for women of child-bearing potential.
• Participant is actively pharmacologically paralyzed at the time of enrollment. NOTE: Participants receiving neuromuscular blockers may be enrolled after a ≥ 12-hour washout period.
• Participant is tracheostomized at the time of enrollment.
• Participant is on home non-invasive ventilation (except for CPAP or BiPAP for obstructive sleep apnea).
• Participant is receiving or expected to receive comfort measures (palliative, hospice, comfort care, etc.) at the time of screening or enrollment.
• Participant is participating in any of the following:
• A study with the same or similar primary endpoint
• A study investigating electrical stimulation or respiratory muscle therapy
• Any study in which the investigator determines may interfere with the results of this study
• Participant is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
• Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results.
• Participant or legally authorized representative is unwilling to provide written informed consent.
• Participant or legally authorized representative is unable to provide written informed consent.

Where it is running

• St. George Hospital — Kogarah, Australia
• Prince of Wales Hospital — Randwick, Australia
• Royal North Shore Hospital — St Leonards, Australia
• 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
• 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

Full record on ClinicalTrials.gov

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