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Completed

NCT Number: NCT05759013

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

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.

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Key information

Conditions

Respiration, Artificial Pathologic Processes Pathological Conditions, Signs and Symptoms Respiration Disorders Respiratory Aspiration Respiratory Tract Diseases Ventilators, Mechanical

Age range

22 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Monash Medical Centre, Clayton, Australia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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:
  • 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.

Treatment and study plan

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.

Other names: 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.

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.

    Time frame: From first FES treatment to 28 days or 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.

Secondary outcomes

  1. Cough peak flow

    Time frame: At 24 hours post-extubation

    Cough peak flow measurement

  2. Maximum expiratory pressure

    Time frame: At 24 hours post-extubation

    Maximum expiratory pressure measurement

  3. Incidence of device-related adverse events

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

    Number of device-related adverse events

  4. Time from first FES treatment administration to ICU discharge

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

    Duration of first FES treatment administration to ICU discharge

  5. Time from first FES treatment administration to hospital discharge

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

    Duration of first FES treatment administration to hospital discharge

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

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

    Number of of patients who were successfully liberated from mechanical ventilation

  7. Incidence of re-intubations

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

    Number of re-intubations

  8. Incidence of readmissions to the ICU

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

    Number of readmissions to the ICU

  9. Incidence of readmissions to the hospital

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

    Number of readmissions to the hospital

  10. Incidence of acute respiratory infections

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

    Number of participants that had diagnosed acute respiratory infections

  11. Incidence of hospital acquired infections

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

    Number of participants that had diagnosed hospital acquired infections

  12. Incidence of tracheostomy

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

    Number of participants that underwent tracheostomies

  13. Mortality

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

    Number of Deaths

  14. Maximum inspiratory pressure

    Time frame: At 24 hours post-extubation

    Maximum inspiratory pressure measurement

  15. Mobility as assessed by the ICU Mobility Scale

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

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

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

    Time frame: At 90 days after treatment

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

Sponsors and collaborators

Lead sponsor

Liberate Medical

Industry

Collaborators

  • United States Department of Defense

Registry information

Official study 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

Acronym: PREVENT

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Mar 8, 2023
Registry last updated
Jun 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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