Diagnosing Malfunctioning Hydrocephalic Shunt Valves With a Flow Sensor
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Purpose
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.
| Condition |
|---|
|
Hydrocephalus |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Cross-Sectional |
| Official Title: | A Flow Monitor for Pediatric Hydrocephalic Shunts - Study of Flow Sensor With the Shunt Valve |
- 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. [ Time Frame: 24 to 48 hours ] [ Designated as safety issue: No ]
- Recording of the pressure waveform related to the volumetric flow of patient cerebrospinal fluid through an Extra-Ventricular Drainage system. [ Time Frame: 24 to 48 hours ] [ Designated as safety issue: No ]
| Enrollment: | 0 |
| Study Start Date: | March 2009 |
| Study Completion Date: | December 2010 |
| Primary Completion Date: | December 2010 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
|
Extraventricular Drainage/Pressure
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 |
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.
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
Contacts and Locations| United States, Wisconsin | |
| Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| 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: | NCT00652249 History of Changes |
| Other Study ID Numbers: | TSI-G-HYDRO-1B-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 Nervous System Diseases Intracranial Hypertension |
ClinicalTrials.gov processed this record on May 16, 2013