Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains.
The study hypothesis is that an ultrasonic flow sensor can accurately measure flow in hydrocephalic shunts.
The ultrasonic sensor will measure cerebrospinal 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.
Nervous System Diseases
Infant, Newborn Diseases
|Study Design:||Observational Model: Cohort
Time Perspective: Cross-Sectional
|Official Title:||A Flow Monitor for Pediatric Hydrocephalic Shunts|
- 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 ]
Biospecimen Retention: Samples With DNA
Cerebrospinal fluid samples are to be retained
|Study Start Date:||August 2010|
|Estimated Study Completion Date:||June 2013|
|Estimated Primary Completion Date:||June 2013 (Final data collection date for primary outcome measure)|
Includes hydrocephalus patients that are in recovery from shunt explanation.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01108965
|United States, New York|
|SUNY Upstate Medical University|
|Syracuse, New York, United States, 13210|
|Principal Investigator:||Cornelis J Drost||Transonic Systems Inc.|
|Principal Investigator:||Satish Krishnamurthy, MD||State University of New York - Upstate Medical University|