Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||A Flow Monitor for Pediatric Hydrocephalic Shunts - Study of Flow Sensor With the Shunt Valve|
- 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. [ Time Frame: 24 to 48 hours ] [ Designated as safety issue: No ]
- Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. [ Time Frame: 24 to 48 hours ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Study Completion Date:||December 2010|
|Primary Completion Date:||December 2010 (Final data collection date for primary outcome measure)|
Includes pediatric hydrocephalus patients that are in recovery from shunt explanation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00652249
|United States, Wisconsin|
|Children's Hospital of Wisconsin|
|Milwaukee, Wisconsin, United States, 53226|
|Principal Investigator:||Cornelis J Drost, BS, MS||Transonic Systems Inc.|
|Study Director:||Bruce A Kaufman, MD||Children's Hospital and Health System Foundation, Wisconsin|