Clinical trial NCT05759013: Pivotal Evaluation of Abdominal Neuromuscular Electrical Stimulation (VentFree) for Weaning From Mechanical Ventilation
Official 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
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Respiration, Artificial
Ventilators, Mechanical
Keywords: Respiratory Muscle Stimulation
Mechanical Ventilation
Lead sponsor: Liberate Medical
Sponsor class: INDUSTRY
Collaborators: name: United States Department of Defense
First posted: 2023-03-08
Enrollment: 272
Sex: ALL
Minimum age (years): 22
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. Participant has been receiving invasive mechanical ventilation for \> 96 hours.
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.

Primary outcomes:
measure: Time from first FES treatment administration to successful liberation during the treatment period of 28 days or until ICU discharge, whichever occurs first.
timeFrame: From first FES treatment to 28 days or ICU discharge, whichever occurs first
Secondary outcomes:
measure: Cough peak flow
timeFrame: At 24 hours post-extubation
measure: Maximum expiratory pressure
timeFrame: At 24 hours post-extubation
measure: Incidence of device-related adverse events
timeFrame: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
measure: Time from first FES treatment administration to ICU discharge
timeFrame: From date of first FES treatment administration to date of ICU discharge or 90 days after treatment, whichever occurs first
measure: Time from first FES treatment administration to hospital discharge
timeFrame: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
measure: Incidence of patients who were successfully liberated from mechanical ventilation
timeFrame: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
measure: Incidence of re-intubations
timeFrame: From date of first FES treatment administration to 90 days after treatment
measure: Incidence of readmissions to the ICU
timeFrame: From date of first FES treatment administration to 90 days after treatment
measure: Incidence of readmissions to the hospital
timeFrame: From date of first FES treatment administration to 90 days after treatment
measure: Incidence of acute respiratory infections
timeFrame: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
measure: Incidence of hospital acquired infections
timeFrame: From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
measure: Incidence of tracheostomy
timeFrame: From date of first FES treatment administration to date of ICU discharge or 90 days after treatment, whichever occurs first
measure: Mortality
timeFrame: From Date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
measure: Maximum inspiratory pressure
timeFrame: At 24 hours post-extubation
measure: Mobility as assessed by the ICU Mobility Scale
timeFrame: Date of ICU discharge or 90 days after treatment, whichever occurs first
measure: Quality of life as assessed by EQ-5D (Quality of Life Survey)
timeFrame: At 90 days after treatment
Other outcomes:
Locations:
city: Hines
country: United States
facility: Edward Hines, Jr. VA Hospital
state: Illinois
city: Maywood
country: United States
facility: Loyola University
state: Illinois
city: Iowa City
country: United States
facility: University of Iowa
state: Iowa
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
city: Cincinnati
country: United States
facility: University of Cincinnati
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Houston
country: United States
facility: Memorial Hermann
state: Texas
city: Everett
country: United States
facility: Providence Regional Medical Center
state: Washington
city: Clayton
country: Australia
facility: Monash Medical Centre
city: Kingswood
country: Australia
facility: Nepean Hospital
city: Kogarah
country: Australia
facility: St. George Hospital
city: Randwick
country: Australia
facility: Prince of Wales Hospital
city: St. Leonards
country: Australia
facility: Royal North Shore Hospital
city: Paris
country: France
facility: Pitié-Salpêtrière University Hospital
city: 's-Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis (JBZ)
city: Nijmegen
country: Netherlands
facility: Canisius Wilhelmina Ziekenhuis (CWZ)
city: Nijmegen
country: Netherlands
facility: Radboud University Medical Center
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
Study officials:
affiliation: Liberate Medical
name: Angus Mclachlan, PhD
role: STUDY_DIRECTOR
References: