This study is a randomized prospective, single-center feasibility study of the use and benefits of NeuRx DPS in patients undergoing tracheostomy for failure to wean.
15 patients undergoing tracheostomy for failure to wean will be randomized into one of 3 cohorts (5 in each cohort): Cohort A: tracheostomy with no intervention; Cohort B: tracheostomy with DPS implantation and immediate stimulation and monitoring and Cohort C: tracheostomy with DPS implantation with monitoring followed with stimulation on day 5.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
4 electrodes are implanted into the diaphragm, 2 on each side, during the tracheostomy procedure. The electrodes are connected to the NeuRx external stimulator which will be used to stimulate and monitor diaphragm activity.
Marmara Univeristy
Istanbul, Turkey (Türkiye)
Device and procedure safety
Device or procedure-related adverse events from time of implant until removal of electrodes prior to discharge from the hospital or 30 days, whichever occurs first
Time frame: Through study completion, an average of 6 years
Monitoring
Detection of rhythmic diaphragm burst activity for identifying the level of diaphragm dysfunction
Time frame: Through study completion, an average of 6 years
Stimulation
Increase in magnitude of diaphragm burst activity with stimulation
Time frame: Through study completion, an average of 6 years
Effects of diaphragm stimulation
Effects of diaphragm stimulation on ventilator parameters (plateau pressure, compliance, tidal volumes), oxygenation, weaning time, extubation failure, and length of stay
Time frame: Through study completion, an average of 6 years
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