Clinical Trial: Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of the NeuRx RA/4 Diaphragmatic Pacemaker in Tetraplegic Patients With Spinal Cord Injuries in Ventilator Support
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.
Detailed Summary:
Sponsor: University of Sao Paulo
Current Primary Outcome: 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 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: Functional rehabilitation by measure of total usage time, both day and night [ Time Frame: One year ]
Original Secondary Outcome: Same as current
Information By: University of Sao Paulo
Dates:
Date Received: June 23, 2011
Date Started: June 2011
Date Completion:
Last Updated: March 18, 2013
Last Verified: March 2013