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

Not Applicable

Withdrawn

• Conditions: Diaphragm Issues; Ventilator-Induced Lung Injury; Tracheostomy
• Interventions: Device: NeuRx Diaphragm Pacing System (DPS)

• Registration Number: NCT04457427
• Lead Sponsor: Synapse Biomedical

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.

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 Timeline

• Study Start: 2016-12
• Status Verified: 2020-03
• Study First Submitted: 2020-03-26
• Study First Submitted QC: 2020-06-30
• Last Update Submitted: 2020-06-30
• Study First Posted: 2020-07-07
• Last Update Posted: 2020-07-07
• Primary Completion: 2022-03
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Trachesotomy with immediate DPS stimulation and monitoring	NeuRx Diaphragm Pacing System (DPS)	5 patients undergoing tracheostomy for failure to wean will have DPS implanted concurrently and receive immediate stimulation and monitoring.
Trachesotomy with DPS monitoring, stimulation on day 5	NeuRx Diaphragm Pacing System (DPS)	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.

Primary Outcome Measures

Name	Time	Method
Stimulation	Through study completion, an average of 6 years	Increase in magnitude of diaphragm burst activity with stimulation
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

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Marmara Univeristy; 🇹🇷 Istanbul, Turkey