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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Respiration, Artificial
- Sponsor
- Liberate Medical
- Enrollment
- 272
- Locations
- 27
- Primary Endpoint
- Time from first FES treatment administration to successful liberation during the treatment period of 28 days or until ICU discharge, whichever occurs first.
- Status
- Enrolling By Invitation
- Last Updated
- 5 months ago
Overview
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.
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.
Investigators
Eligibility Criteria
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/m
- •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.
Outcomes
Primary Outcomes
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
- Cough peak flow(At 24 hours post-extubation)
- 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)
- 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)
- Incidence of patients who were successfully liberated from mechanical ventilation(From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first)
- Incidence of re-intubations(From date of first FES treatment administration to 90 days after treatment)
- Incidence of readmissions to the ICU(From date of first FES treatment administration to 90 days after treatment)
- Incidence of acute respiratory infections(From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first)
- Incidence of readmissions to the hospital(From date of first FES treatment administration to 90 days after treatment)
- Mortality(From Date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first)
- Incidence of hospital acquired infections(From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first)
- Incidence of tracheostomy(From date of first FES treatment administration to date of ICU discharge or 90 days after treatment, whichever occurs first)
- Maximum inspiratory pressure(At 24 hours post-extubation)
- Mobility as assessed by the ICU Mobility Scale(Date of ICU discharge or 90 days after treatment, whichever occurs first)
- Quality of life as assessed by EQ-5D (Quality of Life Survey)(At 90 days after treatment)