A Flow Monitor for Pediatric Hydrocephalic Shunts - Study of Flow Sensor With the Shunt Valve
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Hydrocephalus
- Sponsor
- Transonic Systems Inc.
- Locations
- 1
- Primary Endpoint
- Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage System as a function of the shunt valve pressure release setting and drainage bag position.
- Status
- Withdrawn
- Last Updated
- 13 years ago
Overview
Brief Summary
The study hypothesis is that a transit-time ultrasonic sensor can help doctors diagnose a malfunctioning shunt valve.
The study will simulate an implanted shunt flow monitoring system by placing the flow sensor and a programmable shunt valve into the patient's Extra-Ventricular Drainage line. Flow will be measured as the doctor raises/lowers the drainage bag to simulate the patient sitting up/lying down. The doctor will simulate a malfunctioning shunt by changing the valve's pressure release settings for each cycle of raising/lowering the bag.
By monitoring shunt flow during these changes, the doctors hope to develop new ways to diagnose malfunctioning shunt valves when implanted shunt flow monitors become available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with Hydrocephalus
- •Newborn through age 20
- •External Ventriculostomy with an Extra-Ventricular Drainage system installed
Exclusion Criteria
- •Not diagnosed with Hydrocephalus
- •Older than age 20
- •No External Ventriculostomy with an Extra-Ventricular Drainage system installed
Outcomes
Primary Outcomes
Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage System as a function of the shunt valve pressure release setting and drainage bag position.
Time Frame: 24 to 48 hours
Secondary Outcomes
- Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.(24 to 48 hours)