Monitoring Patient Cerebro-Spinal Fluid Drainage With an Ultrasonic Flow Sensor
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|ClinicalTrials.gov Identifier: NCT00652197|
Recruitment Status : Completed
First Posted : April 3, 2008
Last Update Posted : May 27, 2016
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.
|Condition or disease|
|Study Type :||Observational|
|Actual Enrollment :||16 participants|
|Official Title:||A Flow Monitor for Pediatric Hydrocephalic Shunts - Flow Sensor Study|
|Study Start Date :||March 2009|
|Actual Primary Completion Date :||May 2014|
|Actual Study Completion Date :||May 2014|
Includes pediatric hydrocephalus patients that are in recovery from shunt explanation.
- Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. [ Time Frame: 24-hour period ]
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|