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Shock device may free ICU patients from ventilators faster

NCT ID NCT05759013

Symptom relief Sponsor: Liberate Medical Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a device called VentFree that uses mild electrical pulses to strengthen breathing muscles in critically ill patients on ventilators. 250 adults who had been on a ventilator for 1 to 4 days were randomly assigned to receive either real or sham (fake) treatment. The goal was to see if the device could help them wean off the ventilator sooner and improve cough strength.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

250 people

The number who actually took part.

Started

Feb 2024

Finished

May 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

22 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Participant is ≥ 22 years of age. 2. Participant has been receiving invasive mechanical ventilation for ≥ 24 hours. Exclusion Criteria: 1. Participant has been receiving invasive mechanical ventilation for \> 96 hours. 2. Participant is scheduled or expected to be disconnected from mechanical ventilation ≤ 24 hours after enrollment. 3. Participant was intubated for ≥ 24 hours during a prior episode of invasive mechanical ventilation during current hospitalization. 4. Participant has a BMI ≥ 40 Kg/m2. 5. Participant has no contraction of the abdominal wall muscles in response to abdominal FES as determined by ultrasound. 6. Participant has a pre-existing neuromuscular or muscular disorder that could affect the respiratory muscles (e.g., spinal cord injury or Guillain-Barré syndrome). 7. Participant has had open abdominal surgery ≤ 4 weeks prior to enrollment. 8. Participant has open or damaged skin at area of electrode placements. 9. Participant has a pacemaker and/or implanted electronic device. 10. 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. 11. Participant is actively pharmacologically paralyzed at the time of enrollment. NOTE: Participants receiving neuromuscular blockers may be enrolled after a ≥ 12-hour washout period. 12. Participant is tracheostomized at the time of enrollment. 13. Participant is on home non-invasive ventilation (except for CPAP or BiPAP for obstructive sleep apnea). 14. Participant is receiving or expected to receive comfort measures (palliative, hospice, comfort care, etc.) at the time of screening or enrollment. 15. 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 16. Participant is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits. 17. Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results. 18. Participant or legally authorized representative is unwilling to provide written informed consent. 19. Participant or legally authorized representative is unable to provide written informed consent.

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Conditions

The condition(s) this trial relates to.

Respiratory Aspiration

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Respiration, artificial Ventilators, mechanical

Contacts and locations

Locations

  • Baylor College of Medicine

    Houston, Texas, 77030, United States

  • Canisius Wilhelmina Ziekenhuis (CWZ)

    Nijmegen, Netherlands

  • Centre Hospitalier Universitaire d'Angers

    Angers, 49933, France

  • Edward Hines, Jr. VA Hospital

    Hines, Illinois, 60141, United States

  • Erasmus Medical Center

    Rotterdam, Netherlands

  • Houston Methodist Hospital

    Houston, Texas, 77030, United States

  • Hôpital Saint Joseph Saint Luc

    Lyon, 69365, France

  • Jeroen Bosch Ziekenhuis (JBZ)

    's-Hertogenbosch, Netherlands

  • Loyola University

    Maywood, Illinois, 60153, United States

  • MD Anderson Cancer Center

    Houston, Texas, 077030, United States

  • Memorial Hermann

    Houston, Texas, 77030, United States

  • MemorialCare Long Beach Medical Center

    Long Beach, California, 90807, United States

  • Monash Medical Centre

    Clayton, Australia

  • Nepean Hospital

    Kingswood, Australia

  • Pitié-Salpêtrière University Hospital

    Paris, France

  • Prince of Wales Hospital

    Randwick, Australia

  • Providence Regional Medical Center

    Everett, Washington, 98201, United States

  • Radboud University Medical Center

    Nijmegen, Netherlands

  • Royal North Shore Hospital

    St Leonards, Australia

  • St. George Hospital

    Kogarah, Australia

  • Tufts Medical Center

    Boston, Massachusetts, 02111, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45221, United States

  • University of Florida College of Medicine - Jacksonville

    Jacksonville, Florida, 32206, United States

  • University of Louisville

    Louisville, Kentucky, 40202, United States

  • University of Pittsburgh

    Pittsburgh, Pennsylvania, 15260, United States

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37232, United States

  • Weill Cornell Medicine / New York Presbyterian Hospital

    New York, New York, 10065, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.