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
  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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 15
Study Start Date: March 2009
Estimated Study Completion Date: May 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Extraventricular Drainage
Includes pediatric hydrocephalus patients that are in recovery from shunt explanation.

  Eligibility

Ages Eligible for Study:   up to 20 Years
Genders Eligible for Study:   Both
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
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 ClinicalTrials.gov identifier: NCT00652197

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

No publications provided

Responsible Party: Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT00652197     History of Changes
Other Study ID Numbers: TSI-G-HYDRO-1A-H, 2R44NS049680-02
Study First Received: March 31, 2008
Last Updated: June 4, 2012
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on October 30, 2014