Pivotal Evaluation of Abdominal Neuromuscular Electrical Stimulation (VentFree) for Weaning From Mechanical Ventilation

Respiration, Artificial Clinical Trial

— PREVENT  

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05759013
• Other study ID #: LM-VF-P3
• Secondary ID: CDMRP - PR21220
• Status: Enrolling by invitation
• Phase: N/A
• Start date: February 15, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: April 2024
• Source: Liberate Medical
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Enrolling by invitation
• Enrollment: 272
• Est. completion date: March 31, 2025
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 22 Years and older

Eligibility

Inclusion Criteria:

1. Participant is = 22 years of age.

2. Participant has been receiving invasive mechanical ventilation for = 24 hours but = 72 hours prior to enrollment.

3. Participant or legally authorized representative is willing and able to provide written informed consent.

Exclusion Criteria:

1. Participant is scheduled or expected to be disconnected from mechanical ventilation = 24 hours after enrollment.

2. Participant has a BMI = 40.

3. Participant has no contraction of the abdominal wall muscles in response to abdominal FES as determined by ultrasound.

4. Participant has a pre-existing neuromuscular or muscular disorder that could affect the respiratory muscles (e.g., spinal cord injury or Guillain-Barré syndrome).

5. Participant has had open abdominal surgery = 4 weeks prior to enrollment.

6. Participant has open or damaged skin at area of electrode placements.

7. Participant has a pacemaker and/or implanted electronic device.

8. Participant has expected or diagnosed epilepsy.

9. Participant is being treated for anaphylaxis.

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:

Subjects receiving neuromuscular blockers may be enrolled after a = 12 hour washout period.

12. Participant is ventilated as a result of an uncomplicated elective surgery.

13. The primary reason for ICU admission is an alcohol or drug overdose without secondary complication.

14. Participant is tracheostomized at the time of enrollment.

15. Participant is on home non-invasive ventilation (except for CPAP for obstructive sleep apnea).

16. Participant has a life expectancy < 6 months based on medical history.

17. 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

18. Participant is unable or unwilling to comply with protocol requirements, including assessments, tests, and follow-up visits.

19. Participant has any other medical condition which in the opinion of the Investigator will make participation medically unsafe or interfere with the study results.

Related Conditions & MeSH terms

• Respiration, Artificial
• Ventilators, Mechanical

Intervention

Device:
• Breath synchronized abdominal NMES
Active abdominal stimulation will be applied for 30 minutes twice per day (minimum of four hours between stimulation sessions), five days per week, for 28 days or ICU discharge, whichever comes first.
• Sham breath synchronized abdominal NMES
Sham abdominal stimulation will be applied for 30 minutes twice per day (minimum of four hours between stimulation sessions), five days per week, for 28 days or ICU discharge, whichever comes first.

Locations

Country	Name	City	State
Australia	Monash Medical Centre	Clayton
Australia	St. George Hospital	Kogarah
Australia	Prince of Wales Hospital	Randwick
Australia	Royal North Shore Hospital	St. Leonards
United States	Tufts Medical Center	Boston	Massachusetts
United States	University of Cincinnati	Cincinnati	Ohio
United States	Providence Regional Medical Center	Everett	Washington
United States	Edward Hines, Jr. VA Hospital	Hines	Illinois
United States	Baylor College of Medicine	Houston	Texas
United States	Houston Methodist Hospital	Houston	Texas
United States	MD Anderson Cancer Center	Houston	Texas
United States	Memorial Hermann	Houston	Texas
United States	University of Iowa	Iowa City	Iowa
United States	Loyola University	Maywood	Illinois
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Liberate Medical	United States Department of Defense

Countries where clinical trial is conducted

United States,  Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	From first FES treatment to 28 days or ICU discharge, whichever occurs first
Secondary	Cough peak flow	Cough peak flow measurement	At 24 hours post-extubation
Secondary	Maximum expiratory pressure	Maximum expiratory pressure measurement	At 24 hours post-extubation
Secondary	Incidence of device-related adverse events	Number 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
Secondary	Time from first FES treatment administration to ICU discharge	Duration of 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
Secondary	Time from first FES treatment administration to hospital discharge	Duration of 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
Secondary	Incidence of patients who were successfully liberated from mechanical ventilation	Number of 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
Secondary	Incidence of re-intubations	Number of re-intubations	From date of first FES treatment administration to 90 days after treatment
Secondary	Incidence of readmissions to the ICU	Number of readmissions to the ICU	From date of first FES treatment administration to 90 days after treatment
Secondary	Incidence of readmissions to the hospital	Number of readmissions to the hospital	From date of first FES treatment administration to 90 days after treatment
Secondary	Incidence of acute respiratory infections	Number of participants that had diagnosed acute respiratory infections	From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Secondary	Incidence of hospital acquired infections	Number of participants that had diagnosed hospital acquired infections	From date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Secondary	Incidence of tracheostomy	Number of participants that underwent tracheostomies	From date of first FES treatment administration to date of ICU discharge or 90 days after treatment, whichever occurs first
Secondary	Mortality	Number of Deaths	From Date of first FES treatment administration to date of hospital discharge or 90 days after treatment, whichever occurs first
Secondary	Maximum inspiratory pressure	Maximum inspiratory pressure measurement	At 24 hours post-extubation
Secondary	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)	Date of ICU discharge or 90 days after treatment, whichever occurs first
Secondary	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)	At 90 days after treatment