Selective Laryngeal Reinnervation for Bilateral Vocal Fold Paralysis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Change in breathing function is being assessed and measured by the Dyspnea Index (DI)
研究概览
简要总结
This is a prospective observational study examining the treatment outcomes of selective laryngeal reinnervation procedures for patients with bilateral vocal fold paralysis.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients aged 18-70
- •Patients with bilateral vocal fold paralysis without any improvement for 6 months
排除标准
- •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
结局指标
主要结局
Change in breathing function is being assessed and measured by the Dyspnea Index (DI)
时间窗: 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
时间窗: 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.
次要结局
未报告次要终点