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Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor

A Flow Monitor for Pediatric Hydrocephalic Shunts - Study of Flow Sensor With the Shunt Valve

Status
Withdrawn
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00652249
Enrollment
0
Registered
2008-04-03
Start date
2009-03-31
Completion date
2010-12-31
Last updated
2012-06-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hydrocephalus

Keywords

Hydrocephalus, shunt dysfunction, shunt flow

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.

Interventions

None listed

Sponsors

National Institute of Neurological Disorders and Stroke (NINDS)
CollaboratorNIH
Transonic Systems Inc.
Lead SponsorINDUSTRY

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
No minimum to 20 Years
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system.24 to 48 hours

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026