A Flow Monitor for Pediatric Hydrocephalic Shunts - Flow Sensor Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hydrocephalus
- Sponsor
- Transonic Systems Inc.
- Enrollment
- 16
- Locations
- 1
- Primary Endpoint
- Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.
- Status
- Completed
- Last Updated
- 9 years ago
Overview
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Age: newborn through age 20
- •Diagnosed with Hydrocephalus
- •Instrumented with an Extra-Ventricular Drainage Line
Exclusion Criteria
- •Age: older than age 20
- •Not diagnosed with Hydrocephalus
- •Not instrumented with an Extra-Ventricular Drainage Line
Outcomes
Primary Outcomes
Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.
Time Frame: 24-hour period
Secondary Outcomes
- Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.(24-hour period)