Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With … (NCT04457427) | Clinical Trial Compass
WithdrawnNot Applicable
Randomized Study to Investigate the Safety and Performance of Diaphragm Stimulation Coupled With Mechanical Ventilation
Stopped: Study not started
Turkey (Türkiye)0Started 2016-12
Plain-language 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
What they're measuring
1
Device and procedure safety
Timeframe: Through study completion, an average of 6 years
2
Monitoring
Timeframe: Through study completion, an average of 6 years
3
Stimulation
Timeframe: Through study completion, an average of 6 years