Evaluation of the NeuRx RA/4 Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries in Ventilator Support
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Volume comparison of the basal with the tidal volume obtained with the NeuRx RA/4 pacemaker in patients with diaphragmatic paralysis
Study Overview
Brief Summary
Permanent dependency of breathing apparatus due to spinal cord injury is traditionally treated with different types of mechanical ventilation. However, the electric ventilation became a possibility through their most current versions, such as diaphragmatic pacemakers.
Diaphragmatic pacemakers rhythmically stimulates the diaphragm to replace the functions of the respiratory center that doesn't works well or is inaccessible. However, this modality has the prerequisite that the phrenic nerve and diaphragm muscle are normal. The reason for the development of diaphragmatic pacemaker freeing the patient from the ventilator.
By using the mechanical energy of the diaphragm of the patient, the patient may come not need the ventilator tubing, tracheostomy, and with the help of their caregivers, the inconvenient mechanical ventilators.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •18 years old or more
- •Cervical spinal cord injuries patients under mechanical ventilation
- •Clinically stable after spinal cord injury
- •Clinical acceptable bilateral phrenic nerve function demonstrated with electromyography and neural conduction time
- •Fluoroscopic visible diaphragmatic movements under stimulation
- •Hemodynamically stable
- •No co-morbidities that can interfere with pacemaker implantation or function
- •Pregnancy negative test for women
- •Patient or legal representative informed consent
Exclusion Criteria
- •Active pulmonary disease
- •Active cardiovascular disease
- •Active cerebral disease
- •Hemodynamic instability or low oxygen levels in ambient air
- •Hospitalization for infection in the last 3 months
- •Significant scoliosis or chest disease
- •Poor compliance to the protocol from the patient or the caregiver
Arms & Interventions
NeuRx
Intervention: NeuRx RA/4 diaphragmatic pacemaker (Device)
Outcomes
Primary Outcomes
Volume comparison of the basal with the tidal volume obtained with the NeuRx RA/4 pacemaker in patients with diaphragmatic paralysis
Time Frame: One year
The ability of the NeuRx RA / 4 to obtain clinically acceptable tidal volume during a period of 4 continuous hours will be evaluated by spirometry. Clinically acceptable volume is defined as a volume in excess of 15% above the basal metabolic requirements of the particular patient. For a male patient, the flow volume to meet the basal metabolic requirement is set at 7 ml/kg body weight, while for a female patient, it is defined in 6ml/Kg body weight.
Secondary Outcomes
- Functional rehabilitation by measure of total usage time, both day and night(One year)
Investigators
Miguel L. Tedde
MD, PhD
University of Sao Paulo