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

Completed
Conditions
Hydrocephalus
Registration Number
NCT00652197
Lead Sponsor
Transonic Systems Inc.
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 Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
16
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.24-hour period
Secondary Outcome Measures
NameTimeMethod
Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.24-hour period

Trial Locations

Locations (1)

Children's Hospital of Wisconsin

🇺🇸

Milwaukee, Wisconsin, United States

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