A Flow Monitor for Pediatric Hydrocephalic Shunts - Flow Sensor Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.
研究概览
简要总结
The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in hydrocephalic shunts.
The ultrasonic sensor will measure cerebro-spinal fluid drainage in hydrocephalus patients with external ventriculostomies and extra-ventricular drainage systems. The sensor measurements will be compared with the volume of fluid collected by the drainage bag.
After a 24-hour measurement period, the doctor will change the drainage bag position to simulate the patient sitting up and leaning back, to see if this temporarily stops flow through the drainage line.
This data will show whether the sensor accurately measures typical drainage flows seen in hydrocephalus patients. This research will help develop an implantable flow monitor for pediatric hydrocephalus patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- — 至 20 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: newborn through age 20
- •Diagnosed with Hydrocephalus
- •Instrumented with an Extra-Ventricular Drainage Line
排除标准
- •Age: older than age 20
- •Not diagnosed with Hydrocephalus
- •Not instrumented with an Extra-Ventricular Drainage Line
结局指标
主要结局
Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.
时间窗: 24-hour period
次要结局
- Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.(24-hour period)