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

May 25, 2016 updated by: Transonic Systems Inc.

A Flow Monitor for Pediatric Hydrocephalic Shunts - Flow Sensor Study

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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Actual)

16

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

No

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.

Description

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 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

Cohorts and Interventions

Group / Cohort
Extraventricular Drainage
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.
Time Frame: 24-hour period
24-hour period

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-hour period
24-hour period

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)

May 1, 2014

Study Completion (Actual)

May 1, 2014

Study Registration Dates

First Submitted

March 31, 2008

First Submitted That Met QC Criteria

March 31, 2008

First Posted (Estimate)

April 3, 2008

Study Record Updates

Last Update Posted (Estimate)

May 27, 2016

Last Update Submitted That Met QC Criteria

May 25, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TSI-G-HYDRO-1A-H
  • 2R44NS049680-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hydrocephalus

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Kazakhstan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe