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Study of Shunt Flow Sensor Accuracy in Extra-ventricular Drains.

This study has been completed.
National Institute of Neurological Disorders and Stroke (NINDS)
Information provided by (Responsible Party):
Transonic Systems Inc. Identifier:
First received: April 21, 2010
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 cerebrospinal 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.

Hydrocephalus Nervous System Diseases Infant, Newborn Diseases

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

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 ]

Biospecimen Retention:   Samples With DNA
Cerebrospinal fluid samples are to be retained

Enrollment: 16
Study Start Date: August 2010
Study Completion Date: May 2012
Primary Completion Date: May 2012 (Final data collection date for primary outcome measure)
Extraventricular Drainage
Includes hydrocephalus patients that are in recovery from shunt explanation.


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Hydrocephalus patients under the care of SUNY Upstate Medical University

Inclusion Criteria:

  • Diagnosed with hydrocephalus
  • Instrumented with an Extraventricular drainage system

Exclusion Criteria:

  • Not diagnosed with hydrocephalus
  • Not instrumented with an extraventricular drainage system
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01108965

United States, New York
SUNY Upstate Medical University
Syracuse, New York, United States, 13210
Sponsors and Collaborators
Transonic Systems Inc.
National Institute of Neurological Disorders and Stroke (NINDS)
Principal Investigator: Cornelis J Drost Transonic Systems Inc.
Principal Investigator: Satish Krishnamurthy, MD State University of New York - Upstate Medical University
  More Information

Responsible Party: Transonic Systems Inc. Identifier: NCT01108965     History of Changes
Other Study ID Numbers: TSI-C-HYDRO-2A-H
5R44NS049680-03 ( U.S. NIH Grant/Contract )
Study First Received: April 21, 2010
Last Updated: May 25, 2016

Keywords provided by Transonic Systems Inc.:
Shunt Dysfunction
Shunt Flow

Additional relevant MeSH terms:
Nervous System Diseases
Brain Diseases
Central Nervous System Diseases processed this record on August 22, 2017