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 ]

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.


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 ]

Using spreadsheets to patients and caregivers, will collect information related to the use of the device, such as total usage time, the preference to use it both day and night instead of a mechanical ventilator, or to use it partial time to perform any activity or acquire independence that would otherwise be difficult with mechanical ventilation.


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