Bench Study of Transcutaneous Hydrocephalic Shunt Flow Sensor Alignment Accuracy and Repeatability
NCT ID: NCT00651950
Last Updated: 2012-06-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
OBSERVATIONAL
2009-03-31
2010-12-31
Brief Summary
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The study participants will align the flowmeter probe with a flow sensor hidden under a thick saline pad that simulates skin. A hidden pump will provide a known flow through the flow sensor as the participants make their measurements. Each participant will repeat these measurements over a period of weeks, and the data will tell whether operator skill influences flow measurement accuracy.
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Detailed Description
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The test will involve a prototype implantable hydrocephalic shunt flow sensor and readout electronics. The readout electronics use a pickup coil to transcutaneously operate the sensor once the coil is aligned with sensor's inductive coupling coils.
During the test, the shunt flow sensor will be hidden under a thick saline gel pad whose thickness approximates the skin thickness of an older pediatric patient. A syringe pump will provide a known flow rate through tubing connected to the sensor, but the study participants will not know the pump flow setting.
Three neurosurgeons and six floor nurses will perform this study. Each will use the Transonic flowmeter readout to align the pickup coils of the flowmeter with the hidden sensor to make flow measurements.
Each participant will repeat this measurement multiple times over non-consecutive days.
The recorded data will quantify measurement accuracy and repeatability between different operators, and will determine whether operator skill influences flow measurement accuracy.
Conditions
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Study Design
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COHORT
CROSS_SECTIONAL
Study Groups
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Operator Dependence
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* nurse
Exclusion Criteria
18 Years
ALL
Yes
Sponsors
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National Institute of Neurological Disorders and Stroke (NINDS)
NIH
Transonic Systems Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Cornelis J Drost, BS, MS
Role: PRINCIPAL_INVESTIGATOR
Transonic Systems Inc.
Bruce A Kaufman, MD
Role: STUDY_DIRECTOR
Children's Hospital and Health System Foundation, Wisconsin
Locations
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Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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TSI-G-HYDRO-1C-H
Identifier Type: -
Identifier Source: org_study_id
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