Electrical Activation of The Diaphragm for Ventilatory Assist
Completed · Not applicable
Conditions studied: Spinal Cord Injury, Quadriplegia
In brief
OBJECTIVES: The objectives of this study are to test the Diaphragm Pacing Stimulation (DPS) System for treating chronic ventilatory insufficiency in persons with respiratory muscle paralysis. The hypothesis being tested in the clinical trial is that laparoscopic stimulation of the diaphragm at the motor point with intramuscular electrodes is safe and effective in providing significant ventilatory support to individuals who are otherwise dependant on a mechanical ventilator. Patients in our initial study group have all suffered from high-level spinal cord injury and were full-time dependant on positive pressure mechanical ventilation prior to inclusion.
Key facts
- Study ID
- NCT00010374
- Run by
- Synapse Biomedical
- People needed
- 54
- Starts
- 2000-02-01
- Expected to finish
- 2008-10-01
- Last updated by the study team
- 2020-08-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Age 18 years or older
- Cervical spinal cord injury dependent on mechanical ventilation
- Clinically stable following acute spinal cord injury
- Bilateral phrenic nerve function clinically acceptable as demonstrated with EMG recordings and nerve conduction times
- Diaphragm movement with stimulation visible under fluoroscopy
- Clinically acceptable oxygenation on room air (>90%)
- Hemodynamically stable
- No medical co-morbidities that would interfere with the proper placement or function of the device
- Committed primary caregiver
- Negative pregnancy test in females of child-bearing potential
- Informed consent from patient or designated representative
You may not qualify if…
- Co-morbid medical conditions that preclude surgery
- Active lung disease (obstructive, restrictive or membrane diseases)
- Active cardiovascular disease
- Active brain disease
- Hemodynamic instability or low oxygen levels on room air
- Hospitalization for or a treated active infection within the last 3 months
- Significant scoliosis or chest deformity
- Marked obesity
- Anticipated poor compliance with protocol by either patient or primary caregiver
- Currently breastfeeding
Where it is running
- Craig Hospital — Englewood, Colorado, United States
- Shepherd Center — Atlanta, Georgia, United States
- University Hospital Of Cleveland — Cleveland, Ohio, United States
- The Methodist Hospital — Houston, Texas, United States
- Vancouver CoastHealth — Vancouver, British Columbia, Canada
Full record on ClinicalTrials.gov
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