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临床试验/NCT00845442
NCT00845442已完成不适用

Dynamic Vocal Fold Abduction for Bilateral Paralysis

University Hospitals Cleveland Medical Center2 个研究点 分布在 1 个国家目标入组 6 人开始时间: 2006年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
6
试验地点
2

研究概览

简要总结

People who had paralysis of the vocal cords are often prevented from breathing by this problem because the cords will not open, and the patients have to wear a tracheostomy (neck breathing tube) to bypass this airway obstruction. This study examines the effects of vocal cord opening triggered by a pacemaker implanted over the chest wall. The device is connected to a nerve taken from a muscle close to the larynx (voice box) and implanted into the paralysed laryngeal muscle so it can reinnervate it. When this process is complete after a few weeks, the stimulator is turned on and the level of vocal cord opening is assessed. Airway improvement is checked by pulmonary function tests and measurements of vocal cord opening. The ultimate goal of the study is to lead to situations where patients with bilateral vocal fold paralyses could get rid of the neck breathing tube to have less complications, be more comfortable and socially acceptable.

详细描述

Data pending

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Device Feasibility
盲法
Double (Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Breathing difficulties from vocal cord paralyses
  • Tracheostomy tube
  • Ability to understand the purpose of the research
  • Appropriate hand motor coordination

排除标准

  • Lack of understanding the research
  • Poor hand motor coordination
  • Non-acceptance of tracheostomy
  • Inability to passively move the paralyzed vocal cords

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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