Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor
- Conditions
- Hydrocephalus
- Registration Number
- NCT00652249
- Lead Sponsor
- Transonic Systems Inc.
- Brief Summary
The study hypothesis is that a transit-time ultrasonic sensor can help doctors diagnose a malfunctioning shunt valve.
The study will simulate an implanted shunt flow monitoring system by placing the flow sensor and a programmable shunt valve into the patient's Extra-Ventricular Drainage line. Flow will be measured as the doctor raises/lowers the drainage bag to simulate the patient sitting up/lying down. The doctor will simulate a malfunctioning shunt by changing the valve's pressure release settings for each cycle of raising/lowering the bag.
By monitoring shunt flow during these changes, the doctors hope to develop new ways to diagnose malfunctioning shunt valves when implanted shunt flow monitors become available.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- Diagnosed with Hydrocephalus
- Newborn through age 20
- External Ventriculostomy with an Extra-Ventricular Drainage system installed
- Not diagnosed with Hydrocephalus
- Older than age 20
- No External Ventriculostomy with an Extra-Ventricular Drainage system installed
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage System as a function of the shunt valve pressure release setting and drainage bag position. 24 to 48 hours
- Secondary Outcome Measures
Name Time Method Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. 24 to 48 hours
Trial Locations
- Locations (1)
Children's Hospital of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States