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

Synapse Biomedical

Status: Withdrawn

Conditions: Diaphragm Issues; Tracheostomy; Ventilator-Induced Lung Injury

Treatments: Device: NeuRx Diaphragm Pacing System (DPS)

Study type: Interventional

Funder types: Industry

Identifiers

NCT04457427

CLIN 20-1000-35

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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0 participants in 3 patient groups

Tracheostomy, no DPS

No Intervention group

Description:

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

Trachesotomy with immediate DPS stimulation and monitoring

Experimental group

Description:

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

Treatment:

Device: NeuRx Diaphragm Pacing System (DPS)

Trachesotomy with DPS monitoring, stimulation on day 5

Active Comparator group

Description:

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.

Treatment:

Device: NeuRx Diaphragm Pacing System (DPS)