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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2022-03-31

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.

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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.

Conditions

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Diaphragm Issues Ventilator-Induced Lung Injury Tracheostomy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Tracheostomy, no DPS

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

Group Type NO_INTERVENTION

No interventions assigned to this group

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.

Group Type EXPERIMENTAL

NeuRx Diaphragm Pacing System (DPS)

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

NeuRx Diaphragm Pacing System (DPS)

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type DEVICE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No