Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor

June 4, 2012 updated by: Transonic Systems Inc.

A Flow Monitor for Pediatric Hydrocephalic Shunts - Study of Flow Sensor With the Shunt Valve

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.

Study Overview

Status

Withdrawn

Conditions

Hydrocephalus

Study Type

Observational

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- Wisconsin
  - Milwaukee, Wisconsin, United States, 53226
    - Children's Hospital of Wisconsin

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 20 years (Child, Adult)

Accepts Healthy Volunteers

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Pediatric hydrocephalus patients under the care of the Children's Hospital of Wisconsin, who have had an external ventriculostomy and are instrumented with an Extra-Ventricular Drainage system.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Observational Models: Cohort
Time Perspectives: Cross-Sectional

Number of groups / cohorts

Cohorts and Interventions

Group / Cohort
Extraventricular Drainage/Pressure Includes pediatric hydrocephalus patients that are in recovery from shunt explanation.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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	24 to 48 hours

Secondary Outcome Measures

Outcome Measure	Time Frame
Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. Time Frame: 24 to 48 hours	24 to 48 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Transonic Systems Inc.

Collaborators

National Institute of Neurological Disorders and Stroke (NINDS)

Investigators

Principal Investigator: Cornelis J Drost, BS, MS, Transonic Systems Inc.
Study Director: Bruce A Kaufman, MD, Children's Hospital and Health System Foundation, Wisconsin

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2009

Primary Completion (Actual)

December 1, 2010

Study Completion (Actual)

December 1, 2010

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria