CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 250 enrolled / 250 target
Drug / intervention
Breath synchronized abdominal FES +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05759013
NCT05759013N/ACompletedOn Track (8.8/mo)Completion was 4mo ago
CompareCT.gov

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

Liberate Medical·interventional·Posted Mar 8, 2023·Updated Jun 2, 2026

In Brief

A clinical study evaluating Breath synchronized abdominal FES and Sham breath synchronized abdominal FES for Respiration, Artificial and Ventilators, Mechanical. Completed, enrolled 250 participants across 27 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsRespiration, Artificial, Ventilators, Mechanical
CountriesAustralia, France, Netherlands, United States
CollaboratorsUnited States Department of Defense

Timeline

N/ACompletedFinished
202420252026
First PostedMar 8, 2023
Enrollment StartFeb 15, 2024
Primary CompletionFeb 15, 2026
Study CompletionMay 1, 2026
TodayJul 2, 2026
Enrollment to primary: 2 yearsPosted 3.3 years ago

Arms & Interventions

VentFree Respiratory Muscle Stimulatorexperimental

In the VentFree treatment group, abdominal functional electrical stimulation (FES) will be applied with a frequency of 30 hertz (Hz) and a pulse width of 350µs to cause a strong visible or palpable muscle contraction. The stimulation amplitude will be set to 90% of the participant's maximum tolerable level Discomfort associated with the maximum tolerable level will be recorded on the VAS with pain ratings from zero (no pain) to ten (worst pain). In uncommunicative patients, the maximum tolerable level will be determined as the stimulation intensity that results in a BPS \>4 or CPOT \>2. The stimulation amplitude will be titrated for each participant and each stimulation session. The stimulation amplitude will be evaluated every 10 (± 2) minutes after the start of each stimulation session and adjusted as necessary to maintain a consistent level of visual contraction and to ensure that the stimulation intensity remains within the participant's maximum tolerable level.

Device: Breath synchronized abdominal FES
Sham Respiratory Muscle Stimulatorsham_comparator

In the sham group, abdominal functional electrical stimulation (FES) will be set to cause sensory stimulation but no muscle contraction. Abdominal FES will be applied with a frequency of 30 hertz (Hz), a pulse width of 350 µs and a stimulation amplitude that does not cause abdominal wall muscle contraction. The stimulation amplitude will initially be set at 10 mA and reduced in steps of 2 milliamp (mA) until no muscle contraction is seen.

Device: Sham breath synchronized abdominal FES

Interventions

Breath synchronized abdominal FESdevice

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.

Sham breath synchronized abdominal FESdevice

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.