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

Sponsor

Transonic Systems Inc. (Industry)

Overall Status

Completed

CT.gov ID

NCT01108965

Collaborator

National Institute of Neurological Disorders and Stroke (NINDS) (NIH)

Enrollment

Location

Duration (Months)

0.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Hydrocephalus Nervous System Diseases Infant, Newborn Diseases

Study Design

Study Type:

Observational

Actual Enrollment :

16 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

A Flow Monitor for Pediatric Hydrocephalic Shunts

Study Start Date :

Aug 1, 2010

Actual Primary Completion Date :

May 1, 2012

Actual Study Completion Date :

May 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Extraventricular Drainage Includes hydrocephalus patients that are in recovery from shunt explanation.

Outcome Measures

Primary Outcome Measures

Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. [24 hour-period]

Secondary Outcome Measures

Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. [24 hour period]

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Diagnosed with hydrocephalus
Instrumented with an Extraventricular drainage system

Exclusion Criteria:

Not diagnosed with hydrocephalus
Not instrumented with an extraventricular drainage system

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	SUNY Upstate Medical University	Syracuse	New York	United States	13210

Sponsors and Collaborators

Transonic Systems Inc.
National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator: Cornelis J Drost, Transonic Systems Inc.
Principal Investigator: Satish Krishnamurthy, MD, State University of New York - Upstate Medical University