Clinical Trial: Monitoring Patient Cerebro-Spinal Fluid Drainage With an Ultrasonic Flow Sensor

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: A Flow Monitor for Pediatric Hydrocephalic Shunts - Flow Sensor Study

Brief Summary:

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.

Detailed Summary:
Sponsor: Transonic Systems Inc.

Current Primary Outcome: Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. [ Time Frame: 24-hour period ]

Original Primary Outcome: Same as current

Current Secondary Outcome: 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 ]

Original Secondary Outcome:

Information By: Transonic Systems Inc.

Dates:
Date Received: March 31, 2008
Date Started: March 2009
Date Completion:
Last Updated: May 25, 2016
Last Verified: May 2016