Study of Combined Intercostal and Diaphragm Pacing for Artificial Respiration in Quadriplegic Patients
OBJECTIVES: I. Determine whether combined intercostal muscle and diaphragm pacing can maintain full-time ventilatory support in patients with ventilatory dependent quadriplegia who are not candidates for phrenic nerve pacing alone.
II. Evaluate the efficacy of the Medlink device to produce synchronous intercostal and diagram activation in these patients.
|Study Design:||Primary Purpose: Treatment|
|Study Start Date:||May 1991|
|Estimated Study Completion Date:||September 2000|
PROTOCOL OUTLINE: Patients have a Medlink spinal cord electrode surgically implanted and attached to a radiofrequency receiver implanted subcutaneously over the anterior chest wall.
If substantial inspired volumes can be generated by intercostal pacing, a phrenic nerve cuff electrode and radiofrequency receiver are implanted, and patients undergo combined intercostal muscle and diaphragm pacing.
Completion date provided represents the completion date of the grant per OOPD records
Please refer to this study by its ClinicalTrials.gov identifier: NCT00004415
|Study Chair:||Anthony F. DiMarco||Case Western Reserve University|