Breath Synchronized Abdominal Muscle Stimulation to Facilitate Ventilator Weaning: a Pilot Study

TerminatedINTERVENTIONAL
Enrollment

2

Participants

Timeline

Start Date

February 22, 2017

Primary Completion Date

April 6, 2017

Study Completion Date

April 6, 2017

Conditions
Electric StimulationRespiration, ArtificialVentilator Weaning
Interventions
DEVICE

Breath synchronized abdominal NMES

VentFree prototype (VF03) that delivers electrical stimulation pulses to the abdominal muscles during exhalation with a frequency of 30 Hz, a pulse width of 350 µs and 90% of the maximum current that the participant can tolerate. These stimulation parameters were selected to cause a tetanic (continuous) contraction of the abdominal muscles, without pain for the patient. Stimulation will be administered for 30 minutes 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.

DEVICE

Sham breath synchronized abdominal NMES

Modified VentFree prototype (VF03) that delivers stimulation pulses to the abdominal muscles during exhalation with a frequency of 10 Hz, a pulse width of 100 µs and current set to 10 milliamp. These stimulation parameters were chosen to cause a twitch contraction of the abdominal wall muscles. Stimulation will be administered for 30 minutes, 2 times per day, 5 days per week, for 6 weeks; or until the patient is weaned from mechanical ventilation.

Trial Locations (1)

40204

Kindred Hospital, Louisville

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Liberate Medical

INDUSTRY