Pivotal Evaluation of Abdominal Neuromuscular Electrical Stimulation (VentFree) for Weaning from Mechanical Ventilation
- Conditions
- Ventilators, MechanicalRespiration, Artificial
- Interventions
- Device: Breath synchronized abdominal NMESDevice: Sham breath synchronized abdominal NMES
- Registration Number
- NCT05759013
- Lead Sponsor
- Liberate Medical
- 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.
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 272
- Participant is ≥ 22 years of age.
- Participant has been receiving invasive mechanical ventilation for ≥ 24 hours.
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Participant has been receiving invasive mechanical ventilation for > 96 hours.
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Participant is scheduled or expected to be disconnected from mechanical ventilation ≤ 24 hours after enrollment.
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Participant was intubated for ≥ 24 hours during a prior episode of invasive mechanical ventilation during current hospitalization.
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Participant has a BMI ≥ 40 Kg/m2.
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Participant has no contraction of the abdominal wall muscles in response to abdominal FES as determined by ultrasound.
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Participant has a pre-existing neuromuscular or muscular disorder that could affect the respiratory muscles (e.g., spinal cord injury or Guillain-Barré syndrome).
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Participant has had open abdominal surgery ≤ 4 weeks prior to enrollment.
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Participant has open or damaged skin at area of electrode placements.
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Participant has a pacemaker and/or implanted electronic device.
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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.
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Participant is actively pharmacologically paralyzed at the time of enrollment. NOTE: Participants receiving neuromuscular blockers may be enrolled after a ≥ 12-hour washout period.
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Participant is tracheostomized at the time of enrollment.
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Participant is on home non-invasive ventilation (except for CPAP or BiPAP for obstructive sleep apnea).
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Participant is receiving or expected to receive comfort measures (palliative, hospice, comfort care, etc.) at the time of screening or enrollment.
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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
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Participant is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.
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Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results.
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Participant or legally authorized representative is unwilling to provide written informed consent.
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Participant or legally authorized representative is unable to provide written informed consent.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description VentFree Respiratory Muscle Stimulator Breath synchronized abdominal NMES 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 that does not cause discomfort to the participant. Participant discomfort will be measured using a visual analog pain scale (VAS) with pain ratings from zero (no pain) to ten (worst pain). For participants who are unable to communicate their level of pain, the Behavioral Pain Scale (BPS) will be used. The stimulation will be titrated for each participant and each stimulation session. After the stimulation has been titrated, a visible or palpable contraction of the abdominal wall will be confirmed. The stimulation will be evaluated every 10(± 2) minutes after the start of each stimulation session and adjusted as necessary so that no discomfort is caused to the participant. Sham Respiratory Muscle Stimulator Sham breath synchronized abdominal NMES 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.
- Primary Outcome Measures
Name Time Method Time from first FES treatment administration to successful liberation during the treatment period of 28 days or until ICU discharge, whichever occurs first. 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 Outcome Measures
Name Time Method Cough peak flow At 24 hours post-extubation Cough peak flow measurement
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 Duration of first FES treatment administration to ICU discharge
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 Duration of first FES treatment administration to hospital discharge
Maximum expiratory pressure At 24 hours post-extubation Maximum expiratory pressure measurement
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 Number of device-related adverse events
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 Number of of patients who were successfully liberated from mechanical ventilation
Incidence of re-intubations From date of first FES treatment administration to 90 days after treatment Number of re-intubations
Incidence of readmissions to the ICU From date of first FES treatment administration to 90 days after treatment Number of readmissions to the ICU
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 Number of participants that had diagnosed acute respiratory infections
Incidence of readmissions to the hospital From date of first FES treatment administration to 90 days after treatment Number of readmissions to the hospital
Mortality From Date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first Number of Deaths
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 Number of participants that had diagnosed hospital acquired infections
Incidence of tracheostomy 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
Maximum inspiratory pressure At 24 hours post-extubation Maximum inspiratory pressure measurement
Mobility as assessed by the ICU Mobility Scale 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)
Quality of life as assessed by EQ-5D (Quality of Life Survey) 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)
Trial Locations
- Locations (22)
Nepean Hospital
🇦🇺Kingswood, Australia
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
Edward Hines, Jr. VA Hospital
🇺🇸Hines, Illinois, United States
Loyola University
🇺🇸Maywood, Illinois, United States
University of Iowa
🇺🇸Iowa City, Iowa, United States
Tufts Medical Center
🇺🇸Boston, Massachusetts, 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
St. George Hospital
🇦🇺Kogarah, Australia
Prince of Wales Hospital
🇦🇺Randwick, Australia
Royal North Shore Hospital
🇦🇺St. Leonards, Australia