N/A
N=54
Electrical Activation of The Diaphragm for Ventilatory Assist
Spinal Cord Injury · Quadriplegia
Bottom Line
View on ClinicalTrials.gov: NCT00010374 ↗Enrolled (actual)
54
Serious AEs
15.1%
Results posted
Jul 2020
Primary outcome: Primary: Enrolled Subjects Achieve Clinically Acceptable Tidal Volume Sustained Over a Continuous 4 Hour Period. — 52; 1 Participants — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- NeuRx DPS (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Synapse Biomedical
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Enrolled Subjects Achieve Clinically Acceptable Tidal Volume Sustained Over a Continuous 4 Hour Period. |
52; 1 | <0.001 sig |
| SECONDARY Achieve Clinically Acceptable Basal Metabolic Requirement of Tidal Volume Measured in ml During Chronic Stimulation. |
745.6 | — |
| SECONDARY Number of Patients That Use NeuRx DPS to Breathe Without the Assistance of a Mechanical Ventilator for 24 Continuous Hours a Day |
31 | — |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- 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
Exclusion Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00010374). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.