跳至主要内容
临床试验/NCT00651950
NCT00651950撤回不适用

A Flow Monitor for Pediatric Hydrocephalic Shunts - Bench Study of Sensor Alignment Accuracy and Repeatability

Transonic Systems Inc.1 个研究点 分布在 1 个国家开始时间: 2009年3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
1
主要终点
Standard deviation of error between operator-measured flow measurements and actual flow measurements.

研究概览

简要总结

The study hypothesis is that nurses and doctors can use a transcutaneously powered ultrasonic flow sensor to make repeatable and accurate hydrocephalic shunt flow measurements.

The study participants will align the flowmeter probe with a flow sensor hidden under a thick saline pad that simulates skin. A hidden pump will provide a known flow through the flow sensor as the participants make their measurements. Each participant will repeat these measurements over a period of weeks, and the data will tell whether operator skill influences flow measurement accuracy.

详细描述

The study hypothesis is that a transcutaneously powered ultrasonic flow sensor for hydrocephalic shunts can be repeatedly and accurately read by medical personnel ranging from nurses to senior neurosurgeons.

The test will involve a prototype implantable hydrocephalic shunt flow sensor and readout electronics. The readout electronics use a pickup coil to transcutaneously operate the sensor once the coil is aligned with sensor's inductive coupling coils.

During the test, the shunt flow sensor will be hidden under a thick saline gel pad whose thickness approximates the skin thickness of an older pediatric patient. A syringe pump will provide a known flow rate through tubing connected to the sensor, but the study participants will not know the pump flow setting.

Three neurosurgeons and six floor nurses will perform this study. Each will use the Transonic flowmeter readout to align the pickup coils of the flowmeter with the hidden sensor to make flow measurements.

Each participant will repeat this measurement multiple times over non-consecutive days.

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

入选标准

  • neurosurgeon

排除标准

  • 未提供

结局指标

主要结局

Standard deviation of error between operator-measured flow measurements and actual flow measurements.

时间窗: Daily and weekly

次要结局

  • Flow measurement accuracy vs. the number of times the measurement is conducted.(Daily, weekly)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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