Respiration, Artificial, Ventilators, Mechanical
Conditions
Keywords
Respiratory Muscle Stimulation, Mechanical Ventilation
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.
Interventions
DEVICEBreath synchronized abdominal FES
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.
DEVICESham breath synchronized abdominal FES
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.
Sponsors
Liberate Medical
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
22 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Cough peak flow | At 24 hours post-extubation | Cough peak flow measurement |
| 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 |
| 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 |
| 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 readmissions to the hospital | From date of first FES treatment administration to 90 days after treatment | Number of readmissions to the hospital |
| 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 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 |
| Mortality | From Date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first | Number of Deaths |
| 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) |
Countries
Australia, France, Netherlands, United States
Contacts
STUDY_DIRECTORAngus Mclachlan, PhD
Liberate Medical
Outcome results
None listed