Pivotal Evaluation of Abdominal Neuromuscular Electrical Stimulation (VentFree) for Weaning From Mechanical Ventilation
NCT ID: NCT05759013
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ENROLLING_BY_INVITATION
NA
272 participants
INTERVENTIONAL
2024-02-15
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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VentFree Respiratory Muscle Stimulator
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.
Breath synchronized abdominal FES
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 Respiratory Muscle Stimulator
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.
Sham breath synchronized abdominal FES
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.
Interventions
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Breath synchronized abdominal FES
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 FES
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. Participant has been receiving invasive mechanical ventilation for ≥ 24 hours.
Exclusion Criteria
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.
22 Years
ALL
No
Sponsors
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United States Department of Defense
FED
Liberate Medical
INDUSTRY
Responsible Party
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Principal Investigators
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Angus Mclachlan, PhD
Role: STUDY_DIRECTOR
Liberate Medical
Locations
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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
St. George Hospital
Kogarah, , Australia
Prince of Wales Hospital
Randwick, , Australia
Royal North Shore Hospital
St Leonards, , 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
Radboud University Medical Center
Nijmegen, , Netherlands
Erasmus Medical Center
Rotterdam, , Netherlands
Countries
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Other Identifiers
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CDMRP - PR21220
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
LM-VF-P3
Identifier Type: -
Identifier Source: org_study_id