Hydrocephalus Clinical Trial
Official title:
A Flow Monitor for Pediatric Hydrocephalic Shunts - Bench Study of Sensor Alignment Accuracy and Repeatability
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.
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.
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Observational Model: Cohort, Time Perspective: Cross-Sectional
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