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临床试验/NCT00580346
NCT00580346撤回不适用

Dynamic Laryngotracheal Separation for Aspiration. Prevention of Silent Aspiration Pneumonia During Swallowing by an Implanted Stimulator

University Hospitals Cleveland Medical Center2 个研究点 分布在 1 个国家开始时间: 2004年8月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
2
主要终点
Videotaping vocal cords and modified barium swallows

研究概览

简要总结

People who aspirate after neurologic insults such as stroke often develop fatal pneumonia. This study examines the effects of dynamic vocal cord closure on swallowing. Implants placed over the chest wall are connected to electrodes placed around the nerve that closes the vocal cords. The patient triggers closure by flipping the switch of a coil taped over the skin covering the internal stimulator. Vocal cord motion is verified by videotaping through an endoscope, and the status of swallowing is documented radiologically by a modified barium swallow.

详细描述

Data pending

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
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

  • Aspiration pneumonia after neurological insults (e.g. stroke)
  • Ability to understand the purpose of the research
  • Appropriate hand motor control
  • Inability to improve under standard treatments (speech-language pathologists)
  • Acceptance of a tracheostomy

排除标准

  • Lack of understanding the research
  • Poor hand motor coordination
  • Uncontrolled seizures
  • Pregnancy
  • Refusal to accept a tracheostomy

结局指标

主要结局

Videotaping vocal cords and modified barium swallows

时间窗: several months

次要结局

  • comfort in swallowing(one year)
  • Tolerance of implanted device(immediate to several years)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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