NCT00580346撤回不适用
Dynamic Laryngotracheal Separation for Aspiration. Prevention of Silent Aspiration Pneumonia During Swallowing by an Implanted Stimulator
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
- 否
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
研究点 (2)
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