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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Ventilator-Induced Lung Injury, Tracheostomy, Diaphragm Issues

Intervention / Treatment
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* Device: NeuRx Diaphragm Pacing System (DPS)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Tracheostomy, no DPS<br>5 patients undergoing tracheostomy for failure to wean will receive no additional intervention. | |
| Experimental: Trachesotomy with immediate DPS stimulation and monitoring<br>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)<br>* 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.<br>|
| Active Comparator: Trachesotomy with DPS monitoring, stimulation on day 5<br>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)<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion, an average of 6 years | 
| Monitoring | Detection of rhythmic diaphragm burst activity for identifying the level of diaphragm dysfunction | Through study completion, an average of 6 years | 
| Stimulation | Increase in magnitude of diaphragm burst activity with stimulation | Through study completion, an average of 6 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | Through study completion, an average of 6 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Failure to wean, Lung Injury, Ventilator-Induced, Diaphragm pacing, Tracheostomy, Mechanical Ventilators, Ventilators, Pulmonary