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

This study is not yet open for participant recruitment.

Verified by Transonic Systems Inc., September 2008

Sponsors and Collaborators:	Transonic Systems Inc. Children's Hospital and Health System Foundation, Wisconsin Medical College of Wisconsin
Information provided by:	Transonic Systems Inc.
ClinicalTrials.gov Identifier:	NCT00652197

Purpose

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.

Condition
Hydrocephalus

MedlinePlus related topics: Hydrocephalus

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Cross-Sectional
Official Title:	A Flow Monitor for Pediatric Hydrocephalic Shunts - Flow Sensor Study

Further study details as provided by Transonic Systems Inc.:

Primary Outcome Measures:

Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. [ Time Frame: 24-hour period ] [ Designated as safety issue: No ]

Biospecimen Retention: None Retained

Biospecimen Description:

Estimated Enrollment:	15
Study Start Date:	November 2008
Estimated Study Completion Date:	March 2009
Estimated Primary Completion Date:	March 2009 (Final data collection date for primary outcome measure)

Groups/Cohorts
1 Pediatric hydrocephalus patients that are in recovery from shunt explanation.

Eligibility

Ages Eligible for Study:	up to 20 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Pediatric hydrocephalus patients under the care of the Children's Hospital of Wisconsin.

Criteria

Inclusion Criteria:

Age: newborn through age 20
Hydrocephalus
Instrumented with an Extra-Ventricular Drainage Line

Exclusion Criteria:

None

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00652197

Contacts

Contact: Bruce A Kaufman, MD	414-266-6435	bkaufman@mcw.edu
Contact: Sean M Lew, MD	414-266-6435	slew@mcw.edu

Locations

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

Sponsors and Collaborators

Transonic Systems Inc.

Children's Hospital and Health System Foundation, Wisconsin

Medical College of Wisconsin

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

More Information

This page describes the shunt flow monitor research project and the research team. This link exits the ClinicalTrials.gov site

Responsible Party:	Transonic Systems Inc. ( Cornelis J. Drost, President & CEO, Transonic Systems Inc. )
Study ID Numbers:	TSI-G-HYDRO-1A-H, 2 R44 NS049680-02
Study First Received:	March 31, 2008
Last Updated:	September 18, 2008
ClinicalTrials.gov Identifier:	NCT00652197
Health Authority:	United States: Food and Drug Administration

Keywords provided by Transonic Systems Inc.:

Hydrocephalus
shunt dysfunction
shunt flow

Study placed in the following topic categories:

Pseudotumor cerebri
Pseudotumor Cerebri
Infant, Newborn, Diseases
Central Nervous System Diseases

Hydrocephalus
Brain Diseases
Intracranial Hypertension
Hypertension

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on January 16, 2009