Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation

Sponsor

Synapse Biomedical (Industry)

Overall Status

Withdrawn

CT.gov ID

NCT04457427

Collaborator

(none)

Enrollment

Location

Arms

62.9

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Diaphragm Issues Ventilator-Induced Lung Injury Tracheostomy	Device: NeuRx Diaphragm Pacing System (DPS)	N/A

Detailed Description

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 Design

Study Type:

Interventional

Actual Enrollment :

0 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Prospective, Single-center, Randomized Clinical Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation

Anticipated Study Start Date :

Dec 1, 2016

Anticipated Primary Completion Date :

Mar 1, 2022

Anticipated Study Completion Date :

Mar 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: Tracheostomy, no DPS 5 patients undergoing tracheostomy for failure to wean will receive no additional intervention.
Experimental: Trachesotomy with immediate DPS stimulation and monitoring 5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate stimulation and monitoring.	Device: NeuRx Diaphragm Pacing System (DPS) 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.
Active Comparator: Trachesotomy with DPS monitoring, stimulation on day 5 5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate monitoring followed by stimulation on day 5 post-procedure.	Device: NeuRx Diaphragm Pacing System (DPS) 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.

Arm

Intervention/Treatment

No Intervention: Tracheostomy, no DPS

5 patients undergoing tracheostomy for failure to wean will receive no additional intervention.

Experimental: Trachesotomy with immediate DPS stimulation and monitoring

5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate stimulation and monitoring.

Device: NeuRx Diaphragm Pacing System (DPS)

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.

Active Comparator: Trachesotomy with DPS monitoring, stimulation on day 5

5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate monitoring followed by stimulation on day 5 post-procedure.

Device: NeuRx Diaphragm Pacing System (DPS)

Outcome Measures

Primary Outcome Measures

Device and procedure safety [Through study completion, an average of 6 years]
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
Monitoring [Through study completion, an average of 6 years]
Detection of rhythmic diaphragm burst activity for identifying the level of diaphragm dysfunction
Stimulation [Through study completion, an average of 6 years]
Increase in magnitude of diaphragm burst activity with stimulation

Secondary Outcome Measures

Effects of diaphragm stimulation [Through study completion, an average of 6 years]
Effects of diaphragm stimulation on ventilator parameters (plateau pressure, compliance, tidal volumes), oxygenation, weaning time, extubation failure, and length of stay

Other Outcome Measures

Electrode removal [Through study completion, an average of 6 years]
(3) Safe and complete removal of electrodes prior to discharge from the hospital or thirty (30) days, whichever occurs first

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Patient is intubated, on mechanical ventilation, undergoing tracheostomy, and expected to undergo mechanical ventilation for at least 5 days
Signed written informed consent has been obtained prior to performing any study related procedure(s)
Subject is at least 18 years of age
Negative pregnancy test if the patient is a female of child-bearing potential. (Females of child-bearing potential exclude women who are post-hysterectomy or post-menopausal.)

Exclusion Criteria:

Diaphragm malformation which makes electrode insertion impossible
Presence of an implantable cardioverter-defibrillator
Severe chronic obstructive pulmonary disease (COPD)
Subject is pregnant or breastfeeding
Diagnosis of neuromuscular disease or high level spinal cord injury prior to tracheostomy
Terminal patients expected to die during their stay in the hospital
Participation in other clinical studies that could interfere with the results in the ongoing study