Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains.

Completed

• Conditions: Infant, Newborn Diseases; Nervous System Diseases; Hydrocephalus

• Registration Number: NCT01108965
• 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 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-04-21
• Study First Submitted QC: 2010-04-21
• Study First Posted: 2010-04-22
• Study Start: 2010-08
• Primary Completion: 2012-05
• Study Completion: 2012-05
• Status Verified: 2016-05
• Last Update Submitted: 2016-05-25
• Last Update Posted: 2016-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

Inclusion Criteria

• Diagnosed with hydrocephalus
• Instrumented with an Extraventricular drainage system

Exclusion Criteria

• Not diagnosed with hydrocephalus
• Not instrumented with an extraventricular drainage system

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.	24 hour-period

Secondary Outcome Measures

Name	Time	Method
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)

SUNY Upstate Medical University; 🇺🇸 Syracuse, New York, United States