Monitoring Patient Cerebro-Spinal Fluid Drainage With an Ultrasonic Flow Sensor
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.
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||A Flow Monitor for Pediatric Hydrocephalic Shunts - Flow Sensor Study|
- Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. [ Time Frame: 24-hour period ] [ 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-hour period ] [ Designated as safety issue: No ]
|Study Start Date:||March 2009|
|Estimated Study Completion Date:||May 2013|
|Estimated Primary Completion Date:||May 2013 (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: NCT00652197
|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|