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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00652197
First Posted: April 3, 2008
Last Update Posted: May 27, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Transonic Systems Inc.
  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

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

Resource links provided by NLM:


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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 16
Study Start Date: March 2009
Study Completion Date: May 2014
Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Extraventricular Drainage
Includes pediatric hydrocephalus patients that are in recovery from shunt explanation.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
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
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00652197


Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Transonic Systems Inc.
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
  More Information

Responsible Party: Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT00652197     History of Changes
Other Study ID Numbers: TSI-G-HYDRO-1A-H
2R44NS049680-02 ( U.S. NIH Grant/Contract )
First Submitted: March 31, 2008
First Posted: April 3, 2008
Last Update Posted: May 27, 2016
Last Verified: May 2016

Keywords provided by Transonic Systems Inc.:
Hydrocephalus
shunt dysfunction
shunt flow

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases