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

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT00652197
First received: March 31, 2008
Last updated: June 4, 2012
Last verified: June 2012

March 31, 2008
June 4, 2012
March 2009
May 2013   (final data collection date for primary outcome measure)
Volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. [ Time Frame: 24-hour period ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00652197 on ClinicalTrials.gov Archive Site
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 ] [ Designated as safety issue: No ]
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Monitoring Patient Cerebro-Spinal Fluid Drainage With an Ultrasonic Flow Sensor
A Flow Monitor for Pediatric Hydrocephalic Shunts - Flow Sensor Study

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.

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Observational
Observational Model: Cohort
Time Perspective: Cross-Sectional
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Non-Probability Sample

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

Hydrocephalus
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Extraventricular Drainage
Includes pediatric hydrocephalus patients that are in recovery from shunt explanation.
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Enrolling by invitation
15
May 2013
May 2013   (final data collection date for primary outcome measure)

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
Both
up to 20 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00652197
TSI-G-HYDRO-1A-H, 2R44NS049680-02
No
Transonic Systems Inc.
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
Transonic Systems Inc.
June 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP