Selective Bilateral Laryngeal Reinnervation as a Secondary Treatment in Case of Bilateral Vocal Fold Paralysis: Analysis of Phonatory and Ventilatory Results
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 5
- 试验地点
- 1
- 主要终点
- Maximal phonation time
研究概览
简要总结
Selective laryngeal bilateral reinnervation as a secondary treatment in patients with bilateral vocal fold paralysis, previously treated by endoscopy, without residual arytenoids ankylosis.
The surgical procedure is : functional reinnervation with the upper root of one phrenic nerve, is used for reinnervation of both cricoarytenoid muscles (laryngeal inspiratory muscles), and simultaneous reinnervation of adductor laryngeal muscles is performed by right and left thyro -hyoid nerves (coming from the hypoglossi) on both sides.
Results are obtained after 6 to 9 months delay. In case of good inspiratory arytenoid abduction, and residual dysphonia, a secondary vocal fold medialization is done by an endoscopic approach 12 months after reinnervation (included in the protocol).
Improvement is expected in voice and breathing, without aspiration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient with Bilateral vocal fold paralysis in a closure position 6 months to 36 months before.
- •Patient who has been treated by endoscopic treatment without satisfying result (voice or breathing).
- •Patient with passive mobile arytenoid at least on one side
- •Tracheostomized or not
- •Age > 18 years old
- •Good general situation
排除标准
- •Long term vocal fold paralysis (more than 3 years with strong denervation)
- •Ary-cricoid ankylosis or synechiae
- •Age >75 years
- •Anaesthesiologist contra indication
- •Strong respiratory disease history
- •Severe coagulation troubles
- •Ongoing neoplasia disease
- •Cardiac pace maker
- •Pregnant woman or without contraception
- •Impairment of the freedom
结局指标
主要结局
Maximal phonation time
时间窗: 18 Months
Maximal phonation time will be assessed at 18 Months
次要结局
- Voice quality assessed using quality of life questionnaire(18 Months)
- Voice quality assessed using computerized analysis(18 Months)
- Voice quality assessed using swallowing scores(18 Months)