Status:
WITHDRAWN
Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
Lead Sponsor:
Synapse Biomedical
Conditions:
Diaphragm Issues
Ventilator-Induced Lung Injury
Eligibility:
All Genders
18+ years
Phase:
NA
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 implan...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 1 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2022
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT04457427
Start Date
December 1 2016
End Date
March 1 2022
Last Update
July 7 2020
Active Locations (1)
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1
Marmara Univeristy
Istanbul, Turkey (Türkiye)