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

NCT05759013 | Enrolling By Invitation FDA Device

• 2 other identifiers: LM-VF-P3CDMRP - PR21220
• Study Type: interventional
• Target: 272
• Locations: 4 countries
• Sites: 27

Brief 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.

Conditions

Respiration, Artificial; Ventilators, Mechanical

Keywords

Respiratory Muscle Stimulation; Mechanical Ventilation

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (16)

• Cough peak flow

  At 24 hours post-extubation

• Maximum expiratory pressure

  At 24 hours post-extubation

• Incidence of device-related adverse events

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

• Time from first FES treatment administration to ICU discharge

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

• Time from first FES treatment administration to hospital discharge

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

Study Arms (2)

VentFree Respiratory Muscle Stimulator

EXPERIMENTAL

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 Stimulator

SHAM 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 FES DEVICE

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.

Also known as: VentFree Respiratory Muscle Stimulator

VentFree Respiratory Muscle Stimulator

Sham breath synchronized abdominal FES DEVICE

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.

Sham Respiratory Muscle Stimulator

Eligibility Criteria

• Age: 22 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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:

Sponsors & Collaborators

• Liberate Medical: lead
• United States Department of Defense: collaborator

Study Sites (27)

MemorialCare Long Beach Medical Center

Long Beach, California, 90807, United States

Location

University of Florida College of Medicine - Jacksonville

Jacksonville, Florida, 32206, United States

Location

Edward Hines, Jr. VA Hospital

Hines, Illinois, 60141, United States

Location

Loyola University

Maywood, Illinois, 60153, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Weill Cornell Medicine / New York Presbyterian Hospital

New York, New York, 10065, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45221, United States

Location

University of Pittsburgh

Pittsburgh, Pennsylvania, 15260, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MD Anderson Cancer Center

Houston, Texas, 077030, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

Memorial Hermann

Houston, Texas, 77030, United States

Location

Providence Regional Medical Center

Everett, Washington, 98201, United States

Location

Monash Medical Centre

Clayton, Australia

Location

Nepean Hospital

Kingswood, Australia

Location

St. George Hospital

Kogarah, Australia

Location

Prince of Wales Hospital

Randwick, Australia

Location

Royal North Shore Hospital

St Leonards, Australia

Location

Centre Hospitalier Universitaire d'Angers

Angers, 49933, France

Location

Hôpital Saint Joseph Saint Luc

Lyon, 69365, France

Location

Pitié-Salpêtrière University Hospital

Paris, France

Location

Jeroen Bosch Ziekenhuis (JBZ)

's-Hertogenbosch, Netherlands

Location

Canisius Wilhelmina Ziekenhuis (CWZ)

Nijmegen, Netherlands

Location

Radboud University Medical Center

Nijmegen, Netherlands

Location

Erasmus Medical Center

Rotterdam, Netherlands

Location

MeSH Terms

Conditions

Respiratory Aspiration

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Angus Mclachlan, PhD

  Liberate Medical

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 16, 2023
• First Posted: March 8, 2023
• Study Start: February 15, 2024
• Primary Completion: December 31, 2025
• Study Completion: March 31, 2026
• Last Updated: November 12, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (4); AU (5); FR (3); US (15)