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

NCT00652197 | Completed

• 2 other identifiers: TSI-G-HYDRO-1A-H2R44NS049680-02
• Study Type: observational
• Target: 16
• Locations: 1 country
• Sites: 1

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.

Conditions

Hydrocephalus

Keywords

Hydrocephalus; shunt dysfunction; shunt flow

Outcome Measures

Primary Outcomes (1)

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

  24-hour period

Secondary Outcomes (1)

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

  24-hour period

Study Arms (1)

Extraventricular Drainage

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

Eligibility Criteria

• Age: Up to 20 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Age: newborn through age 20
• Diagnosed with Hydrocephalus
• Instrumented with an Extra-Ventricular Drainage Line

You may not qualify if:

• Age: older than age 20
• Not diagnosed with Hydrocephalus
• Not instrumented with an Extra-Ventricular Drainage Line

Sponsors & Collaborators

• Transonic Systems Inc.: lead
• National Institute of Neurological Disorders and Stroke (NINDS): collaborator

Study Sites (1)

Children's Hospital of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

MeSH Terms

Conditions

Hydrocephalus

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• Cornelis J Drost, BS, MS

  Transonic Systems Inc.

  PRINCIPAL INVESTIGATOR

• Bruce A Kaufman, MD

  Children's Hospital and Health System Foundation, Wisconsin

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2008
• First Posted: April 3, 2008
• Study Start: March 1, 2009
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: May 27, 2016

Record last verified: 2016-05

Locations

US (1)