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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
272
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.
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.
MemorialCare Long Beach Medical Center
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.
Time frame: From first FES treatment to 28 days or ICU discharge, whichever occurs first
Cough peak flow
Cough peak flow measurement
Time frame: At 24 hours post-extubation
Maximum expiratory pressure
Maximum expiratory pressure measurement
Time frame: At 24 hours post-extubation
Incidence of device-related adverse events
Number 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
Time from first FES treatment administration to ICU discharge
Duration of 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
Time from first FES treatment administration to hospital discharge
Duration of 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
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Long Beach, California, United States
University of Florida College of Medicine - Jacksonville
Jacksonville, Florida, United States
Edward Hines, Jr. VA Hospital
Hines, Illinois, United States
Loyola University
Maywood, Illinois, United States
University of Louisville
Louisville, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
Weill Cornell Medicine / New York Presbyterian Hospital
New York, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
University of Pittsburgh
Pittsburgh, Pennsylvania, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
...and 17 more locations
Incidence of patients who were successfully liberated from mechanical ventilation
Number of 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
Incidence of re-intubations
Number of re-intubations
Time frame: From date of first FES treatment administration to 90 days after treatment
Incidence of readmissions to the ICU
Number of readmissions to the ICU
Time frame: From date of first FES treatment administration to 90 days after treatment
Incidence of readmissions to the hospital
Number of readmissions to the hospital
Time frame: From date of first FES treatment administration to 90 days after treatment
Incidence of acute respiratory infections
Number of participants that had diagnosed 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
Incidence of hospital acquired infections
Number of participants that had diagnosed 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
Incidence of tracheostomy
Number of participants that underwent tracheostomies
Time frame: From date of first FES treatment administration to date of ICU discharge or 90 days after treatment, whichever occurs first
Mortality
Number of Deaths
Time frame: From Date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Maximum inspiratory pressure
Maximum inspiratory pressure measurement
Time frame: At 24 hours post-extubation
Mobility as assessed by the ICU Mobility Scale
Mobility assessment score from 0 (participant is unable to move) - 10 (participant is able to walk independently)
Time frame: Date of ICU discharge or 90 days after treatment, whichever occurs first
Quality of life as assessed by EQ-5D (Quality of Life Survey)
Five (5) level Quality of Life assessment ranging from Level 1 (indicating no problem) to Level 5 (indicating unable to/extreme problems)
Time frame: At 90 days after treatment