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WITHDRAWNNANCT04457427

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

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.

Lead sponsor: Synapse Biomedical•1 locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Synapse Biomedical

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.

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

No

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

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: July 7, 2020Terms

Trial snapshot

StatusWITHDRAWN

PhaseNA

Enrollment—

Start dateDec 2016

Last updatedJul 7, 2020

Condition

Diaphragm Issues Ventilator-Induced Lung Injury Tracheostomy

Locations shown

Marmara Univeristy

Istanbul

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 7, 2020Data synced to Clareo: May 25, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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