Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains.
|ClinicalTrials.gov Identifier: NCT01108965|
Recruitment Status : Completed
First Posted : April 22, 2010
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 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.
|Condition or disease|
|Hydrocephalus Nervous System Diseases Infant, Newborn Diseases|
|Study Type :||Observational|
|Actual Enrollment :||16 participants|
|Official Title:||A Flow Monitor for Pediatric Hydrocephalic Shunts|
|Study Start Date :||August 2010|
|Actual Primary Completion Date :||May 2012|
|Actual Study Completion Date :||May 2012|
Includes 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 ]
Biospecimen Retention: Samples With DNA
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|