Study of Combined Intercostal and Diaphragm Pacing for Artificial Respiration in Quadriplegic Patients
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About
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.
Full 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
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Inclusion and exclusion criteria
PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Ventilator dependent quadriplegics who are not candidates for phrenic nerve pacing alone
Must have bilateral partial or unilateral phrenic nerve function
Must have been on ventilator support for at least 6 months and unweanable
--Patient Characteristics--
Cardiovascular: No active cardiovascular disease
Pulmonary: No active lung disease
Other: No active brain disease Stable condition
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Data sourced from clinicaltrials.gov
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