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临床试验/NCT06642129
NCT06642129招募中不适用

A Prospective Observational Study of Perioperative Lumbar Puncture Pressure and Shunt Valve Pressure Management in Patients with Traffic Hydrocephalus Undergoing Lumbopeitoneal Shunt Surgery

RenJi Hospital1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年6月1日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
30
试验地点
1
主要终点
primary outcome

研究概览

简要总结

Target population: patients 18 years of age or older who require surgical treatment with lumboperitoneal shunt surgery for traffic hydrocephalus Estimated sample size: 30 cases. Study design: this study is a multicenter prospective observational study, with lumbar puncture pressure measurement before and during surgery, and shunt valve setting pressure set according to the requirements of clinical practice in the hospital where it is performed, and the collection of relevant data, including preoperative lumbar puncture pressure, intraoperative lumbar puncture pressure after anesthesia, shunt valve initial pressure, shunt valve pressure at 6 months pressure, length of the intravertebral shunt, and length of the intraperitoneal shunt. Complications, shunt effects, and the number of shunt valve adjustments during the 6-month period were also observed and recorded.

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

入排标准

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

入选标准

  • Age of 18 years or older;
  • Confirmed diagnosis of communicating hydrocephalus;
  • Signed informed consent for surgery and informed consent for research.

排除标准

  • Pregnant women;
  • Inappropriate for lumboperitoneal shunt surgery despite the diagnosis of communicating hydrocephalus.

结局指标

主要结局

primary outcome

时间窗: preoperation to 6 months after surgery

1. Measurement of preoperative bedside lumbar puncture pressure(cmH2O); 2. Measurement of lumbar puncture pressure after anesthesia during lumboperitoneal shunt surgery(cmH2O) ; 3. Initial setting of shunt valve; 4. Setting of shunt valve at 6 months after lumboperitoneal shunt surgery

次要结局

  • secondary outcome(preoperation to 6 months after surgery)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Junfeng Feng

Chief Director of Brain Injury Center

RenJi Hospital

研究点 (1)

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