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

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Brief Title

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

Official Title

A Flow Monitor for Pediatric Hydrocephalic Shunts - Flow Sensor Study

Brief Summary

      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


Primary Outcome

Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.

Secondary Outcome

 Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.

Condition

Hydrocephalus


Study Arms / Comparison Groups

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

16

Start Date

March 2009

Completion Date

May 2014

Primary Completion Date

May 2014

Eligibility 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
      

Gender

All

Ages

N/A - 20 Years

Accepts Healthy Volunteers

No

Contacts

Cornelis J Drost, BS, MS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00652197

Organization ID

TSI-G-HYDRO-1A-H

Secondary IDs

2R44NS049680-02

Responsible Party

Sponsor

Study Sponsor

Transonic Systems Inc.

Collaborators

 National Institute of Neurological Disorders and Stroke (NINDS)

Study Sponsor

Cornelis J Drost, BS, MS, Principal Investigator, Transonic Systems Inc.


Verification Date

May 2016