NCT00004415

Study of Combined Intercostal and Diaphragm Pacing for Artificial Respiration in Quadriplegic Patients

• Status: Terminated
• Phase: N/A
• Study type: Interventional
• Enrollment: 5 (planned)
• Sponsor: Case Western Reserve University · Academic / Other
• Sex: All
• Age: 18 Years – 49 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• Quadriplegia

Interventions

Type	Name	Description
DEVICE	Medlink spinal cord electrode

Timeline

• Start date: 1991-05-01
• Completion: 2000-09-01
• First posted: 1999-10-19
• Last updated: 2015-04-07