Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor

NCT00652249 | Withdrawn

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

Brief Summary

The study hypothesis is that a transit-time ultrasonic sensor can help doctors diagnose a malfunctioning shunt valve. The study will simulate an implanted shunt flow monitoring system by placing the flow sensor and a programmable shunt valve into the patient's Extra-Ventricular Drainage line. Flow will be measured as the doctor raises/lowers the drainage bag to simulate the patient sitting up/lying down. The doctor will simulate a malfunctioning shunt by changing the valve's pressure release settings for each cycle of raising/lowering the bag. By monitoring shunt flow during these changes, the doctors hope to develop new ways to diagnose malfunctioning shunt valves when implanted shunt flow monitors become available.

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 as a function of the shunt valve pressure release setting and drainage bag position.

  24 to 48 hours

Secondary Outcomes (1)

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

  24 to 48 hours

Study Arms (1)

Extraventricular Drainage/Pressure

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, who have had an external ventriculostomy and are instrumented with an Extra-Ventricular Drainage system.

You may qualify if:

• Diagnosed with Hydrocephalus
• Newborn through age 20
• External Ventriculostomy with an Extra-Ventricular Drainage system installed

You may not qualify if:

• Not diagnosed with Hydrocephalus
• Older than age 20
• No External Ventriculostomy with an Extra-Ventricular Drainage system installed

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: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: June 5, 2012

Record last verified: 2012-06

Locations

US (1)