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Clinical Trials/NCT00651950
NCT00651950
Withdrawn
N/A

A Flow Monitor for Pediatric Hydrocephalic Shunts - Bench Study of Sensor Alignment Accuracy and Repeatability

Transonic Systems Inc.1 site in 1 countryMarch 2009
ConditionsHydrocephalus

Overview

Phase
N/A
Intervention
Not specified
Conditions
Hydrocephalus
Sponsor
Transonic Systems Inc.
Locations
1
Primary Endpoint
Standard deviation of error between operator-measured flow measurements and actual flow measurements.
Status
Withdrawn
Last Updated
13 years ago

Overview

Brief Summary

The study hypothesis is that nurses and doctors can use a transcutaneously powered ultrasonic flow sensor to make repeatable and accurate hydrocephalic shunt flow measurements.

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.

Detailed Description

The study hypothesis is that a transcutaneously powered ultrasonic flow sensor for hydrocephalic shunts can be repeatedly and accurately read by medical personnel ranging from nurses to senior neurosurgeons. 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.

Registry
clinicaltrials.gov
Start Date
March 2009
End Date
December 2010
Last Updated
13 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • neurosurgeon

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Standard deviation of error between operator-measured flow measurements and actual flow measurements.

Time Frame: Daily and weekly

Secondary Outcomes

  • Flow measurement accuracy vs. the number of times the measurement is conducted.(Daily, weekly)

Study Sites (1)

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