Diaphragm Issues, Tracheostomy, Ventilator-Induced Lung Injury
Conditions
Keywords
Mechanical Ventilators, Ventilators, Pulmonary, Failure to wean, Lung Injury, Ventilator-Induced, Tracheostomy, Diaphragm pacing
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.
Interventions
4 electrodes are implanted into the diaphragm, 2 on each side, during the tracheostomy procedure. The electrodes are connected to the NeuRx external stimulator which will be used to stimulate and monitor diaphragm activity.
Sponsors
Synapse Biomedical
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Stimulation | Through study completion, an average of 6 years | Increase in magnitude of diaphragm burst activity with stimulation |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Other
| Measure | Time frame | Description |
|---|---|---|
| Electrode removal | Through study completion, an average of 6 years | (3) Safe and complete removal of electrodes prior to discharge from the hospital or thirty (30) days, whichever occurs first |
Countries
Turkey (Türkiye)
Outcome results
None listed