NCT04363658Unknown不适用
Efficacy Study of Shunt Operation in Patients With Disorder of Consciousness of Post-traumatic Hydrocephalus (PTH) by Methods of Neuroelectrophysiology
Xiangya Hospital of Central South University1 个研究点 分布在 1 个国家目标入组 65 人开始时间: 2020年5月10日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- Score of glasgow outcome scale in 6 months after shunt operation
研究概览
简要总结
The symptoms of hydrocephalus containing consciousness condition with muscle tone in some patients will be relieved, after the cerebrospinal fluid release test is carried out. Neuroelectrophysiology in patients with disorders of consciousness of post-traumatic hydrocephalus (PTH) can establish the association with consciousness and muscle tone to a certain extent, and predict the shunt effect of PTH with disorders of consciousness.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 16 Years 至 70 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with disorder of consciousness in traumatic brain injury. The presence of hydrocephalus through image examination.
排除标准
- •Patients who cannot tolerate shunt surgery. Sedation maintained by greater than 0.15mg/kg/hour of midazolam or the infusion dose of propofol higher than 4mg/kg/hour.
- •Patients who are participating in drug research or other clinical trials.
结局指标
主要结局
Score of glasgow outcome scale in 6 months after shunt operation
时间窗: 6 months
次要结局
- Modified Ashworth Scale (MAS) in 1 month after shunting(1 month)
- Revised coma recovery scale (CRS-R) in 1 week after shunting(1 week)
- Score of glasgow outcome scale in 6 months after shunting under different ventricular pressure(6 months)
- Revised coma recovery scale (CRS-R) in 1 month after shunting(1 month)
- Modified Ashworth Scale (MAS) in 1 week after shunting(1 week)
研究者
研究点 (1)
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