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Respiration, ArtificialPREVENTNCT05759013

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

A study testing Breath synchronized abdominal FES in people with Respiration, Artificial and Ventilators, Mechanical, run by Liberate Medical at 27 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 22 years and older
What is being tested?
Breath synchronized abdominal FES
Type of treatment
Medical device
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
27 sitesin 4 countries
Study dates
15 Feb 2024to 1 May 2026
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 22 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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).
Show all 22Show fewer
  • 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.

Trial locations and contacts

27 sites in 4 countries.

27 sites in 4 countries

United States15 sites

  • Tufts Medical Center

    Boston, Massachusetts, 02111

  • University of Cincinnati

    Cincinnati, Ohio, 45221

  • Providence Regional Medical Center

    Everett, Washington, 98201

  • Edward Hines, Jr. VA Hospital

    Hines, Illinois, 60141

  • MD Anderson Cancer Center

    Houston, Texas, 077030

  • Baylor College of Medicine

    Houston, Texas, 77030

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • Memorial Hermann

    Houston, Texas, 77030

  • University of Florida College of Medicine - Jacksonville

    Jacksonville, Florida, 32206

  • MemorialCare Long Beach Medical Center

    Long Beach, California, 90807

  • University of Louisville

    Louisville, Kentucky, 40202

  • Loyola University

    Maywood, Illinois, 60153

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232

  • Weill Cornell Medicine / New York Presbyterian Hospital

    New York, New York, 10065

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260

Other trials in United States

Australia5 sites

  • Monash Medical Centre

    Clayton

  • Nepean Hospital

    Kingswood

  • St. George Hospital

    Kogarah

  • Prince of Wales Hospital

    Randwick

  • Royal North Shore Hospital

    St Leonards

Other trials in Australia

Netherlands4 sites

  • Jeroen Bosch Ziekenhuis (JBZ)

    's-Hertogenbosch

  • Canisius Wilhelmina Ziekenhuis (CWZ)

    Nijmegen

  • Radboud University Medical Center

    Nijmegen

  • Erasmus Medical Center

    Rotterdam

Other trials in Netherlands

France3 sites

  • Centre Hospitalier Universitaire d'Angers

    Angers, 49933

  • Hôpital Saint Joseph Saint Luc

    Lyon, 69365

  • Pitié-Salpêtrière University Hospital

    Paris

Other trials in France

About this study

Official title: 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

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.

Read the detailed description

Approximately 40% of patients who receive invasive ventilation require more than four days of ventilator support. Every additional day of mechanical ventilation results in increased patient morbidity and mortality and increased economic cost. Mechanically ventilated patients often develop expiratory muscle weakness, which has been linked to failed extubation and weaning.

Neuromuscular electrical stimulation (NMES) uses electrical pulses to induce a muscle contraction and has been shown to reduce or retard muscle atrophy. NMES applied to the abdominal wall muscles has been shown to improve respiratory function and assist ventilator weaning in spinal cord injury. Liberate Medical has previously shown that NMES applied to the abdominal wall muscles in synchrony with exhalation is feasible in patients receiving invasive mechanical ventilation. This study is a pivotal evaluation of the efficacy of exhalation synchronized abdominal NMES to assist ventilator weaning in critically ill patients.

Being tested
Breath synchronized abdominal FES, Sham breath synchronized abdominal FES
Keywords
Respiratory Muscle Stimulation, Mechanical Ventilation
Medical subject headings
Respiratory Aspiration

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Breath synchronized abdominal FESDevice

    Also called VentFree Respiratory Muscle Stimulator

    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.

Study groups in NCT05759013
Study groupRoleWhat they receive
VentFree Respiratory Muscle StimulatorExperimentalIn 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.
Receives: Device: Breath synchronized abdominal FES
Sham Respiratory Muscle StimulatorSham comparatorIn 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.
Receives: Device: Sham breath synchronized abdominal FES

What is being measured

The primary outcome is the main question the study is designed to answer.

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

    Successful liberation is defined as disconnection from mechanical ventilation that does not require invasive mechanical ventilation in the subsequent 7 days after disconnection, or until ICU discharge, or until live hospital discharge, whichever occurs first.

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

Secondary outcomes (16)

  1. Cough peak flow

    Cough peak flow measurement

    Measured: At 24 hours post-extubation

  2. Maximum expiratory pressure

    Maximum expiratory pressure measurement

    Measured: At 24 hours post-extubation

  3. Incidence of device-related adverse events

    Number of device-related adverse events

    Measured: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first

  4. Time from first FES treatment administration to ICU discharge

    Duration of first FES treatment administration to ICU discharge

    Measured: From date of first FES treatment administration to date of ICU discharge or 90 days after treatment, whichever occurs first

  5. Time from first FES treatment administration to hospital discharge

    Duration of first FES treatment administration to hospital discharge

    Measured: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first

  6. Incidence of patients who were successfully liberated from mechanical ventilation

    Number of of patients who were successfully liberated from mechanical ventilation

    Measured: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first

  7. Incidence of re-intubations

    Number of re-intubations

    Measured: From date of first FES treatment administration to 90 days after treatment

  8. Incidence of readmissions to the ICU

    Number of readmissions to the ICU

    Measured: From date of first FES treatment administration to 90 days after treatment

  9. Incidence of readmissions to the hospital

    Number of readmissions to the hospital

    Measured: From date of first FES treatment administration to 90 days after treatment

  10. Incidence of acute respiratory infections

    Number of participants that had diagnosed acute respiratory infections

    Measured: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first

  11. Incidence of hospital acquired infections

    Number of participants that had diagnosed hospital acquired infections

    Measured: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first

  12. Incidence of tracheostomy

    Number of participants that underwent tracheostomies

    Measured: From date of first FES treatment administration to date of ICU discharge or 90 days after treatment, whichever occurs first

  13. Mortality

    Number of Deaths

    Measured: From Date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first

  14. Maximum inspiratory pressure

    Maximum inspiratory pressure measurement

    Measured: At 24 hours post-extubation

  15. Mobility as assessed by the ICU Mobility Scale

    Mobility assessment score from 0 (participant is unable to move) - 10 (participant is able to walk independently)

    Measured: Date of ICU discharge or 90 days after treatment, whichever occurs first

  16. Quality of life as assessed by EQ-5D (Quality of Life Survey)

    Five (5) level Quality of Life assessment ranging from Level 1 (indicating no problem) to Level 5 (indicating unable to/extreme problems)

    Measured: At 90 days after treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2023
  2. Study start15 Feb 2024
  3. Primary completion15 Feb 2026
  4. Study completion1 May 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
250 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05759013
Sponsor's protocol ID
LM-VF-P3
Other IDs
CDMRP - PR21220
Acronym
PREVENT
Status last verified
May 2026
First submitted
16 Jan 2023
Last updated
2 Jun 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • McCaughey EJ, McLachlan AJ, Cai J, Cohen Freue G, Demoule A, Gotur DB, Hill NS, Dimatteo C, Oliva SP, Patel MB, Girard TD, Heunks L. Randomised, sham-controlled, double-blinded, multicentre international trial to evaluate the efficacy of the Ventfree Respiratory Muscle Stimulator to assist ventilator weaning in critically ill patients: a study protocol of a randomised controlled trial. BMJ Open. 2026 Apr 21;16(4):e113540. doi: 10.1136/bmjopen-2025-113540.

    PubMed 42014152

Questions about this trial

What is this clinical trial studying?

A study testing Breath synchronized abdominal FES in people with Respiration, Artificial and Ventilators, Mechanical, run by Liberate Medical at 27 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States, Australia, Netherlands, France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time from first FES treatment administration to successful liberation during the treatment period of 28 days or until ICU discharge, whichever occurs first. (time frame: From first FES treatment to 28 days or ICU discharge, whichever occurs first). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05759013, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.

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