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

This study has been completed.
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Transonic Systems Inc. Identifier:
First received: March 31, 2008
Last updated: May 25, 2016
Last verified: May 2016

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 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)
Extraventricular Drainage
Includes pediatric hydrocephalus patients that are in recovery from shunt explanation.


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.

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
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Please refer to this study by its identifier: NCT00652197

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)
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. Identifier: NCT00652197     History of Changes
Other Study ID Numbers: TSI-G-HYDRO-1A-H
2R44NS049680-02 ( US NIH Grant/Contract Award Number )
Study First Received: March 31, 2008
Last Updated: May 25, 2016

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

Additional relevant MeSH terms:
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases processed this record on May 25, 2017