Bench Study of Transcutaneous Hydrocephalic Shunt Flow Sensor Alignment Accuracy and Repeatability

Hydrocephalus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00651950
• Other study ID #: TSI-G-HYDRO-1C-H
• Secondary ID: 2R44NS049680-02
• Status: Withdrawn
• Phase: N/A
• First received: March 31, 2008
• Last updated: June 4, 2012
• Start date: March 2009
• Est. completion date: December 2010

Study information

• Verified date: June 2012
• Source: Transonic Systems Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2010
• Est. primary completion date: December 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• neurosurgeon

• nurse

Exclusion Criteria:

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Hydrocephalus

Locations

Country	Name	City	State
United States	Children's Hospital of Wisconsin	Milwaukee	Wisconsin

Sponsors (2)

Lead Sponsor	Collaborator
Transonic Systems Inc.	National Institute of Neurological Disorders and Stroke (NINDS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Standard deviation of error between operator-measured flow measurements and actual flow measurements.		Daily and weekly	No
Secondary	Flow measurement accuracy vs. the number of times the measurement is conducted.		Daily, weekly	No

External Links

•   This page describes the shunt flow monitor research project and the research team.