Selective Laryngeal Reinnervation for Bilateral Vocal Fold Paralysis
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Bilateral Vocal Cord Paralysis
- Sponsor
- Weill Medical College of Cornell University
- Enrollment
- 15
- Locations
- 2
- Primary Endpoint
- Change in breathing function is being assessed and measured by the Dyspnea Index (DI)
- Status
- Recruiting
- Last Updated
- 11 days ago
Overview
Brief Summary
This is a prospective observational study examining the treatment outcomes of selective laryngeal reinnervation procedures for patients with bilateral vocal fold paralysis.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients aged 18-70
- •Patients with bilateral vocal fold paralysis without any improvement for 6 months
Exclusion Criteria
- •Patients with neck or chest radiation
- •Patients with severe respiratory compromise
- •Patients with cricoarytenoid ankylosis
- •Patients with pacemakers
- •Patients who are pregnant
- •Patients with cochlear implant, or any nerve stimulator implants
Outcomes
Primary Outcomes
Change in breathing function is being assessed and measured by the Dyspnea Index (DI)
Time Frame: Pre-surgery and then post-surgery at 1 week, 1 month, 3 months and every 3 months thereafter up to 18 months, then at 24 months
The DI is a standardized and validated tool to quantify patients' symptoms of upper airway dyspnea. It's a 10-item questionnaire. The lowest score is 0, which indicates that the patient is never experiencing dyspnea symptoms, and the highest is 40, which indicates that the patient is always experiencing dyspnea symptoms.
Change in breathing function is being assessed and measured by pulmonary function testing
Time Frame: Pre-surgery and then post-surgery at 1 week, 1 month, 3 months and every 3 months thereafter up to 18 months, then at 24 months
Pulmonary function testing will measure the total inspiratory and expiratory tidal volumes.