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

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Brief Title

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

Official Title

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

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.
    


Study Type

Observational


Primary Outcome

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

Secondary Outcome

 Flow measurement accuracy vs. the number of times the measurement is conducted.

Condition

Hydrocephalus


Study Arms / Comparison Groups

 Operator Dependence
Description:  

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information



Estimated Enrollment

0

Start Date

March 2009

Completion Date

December 2010

Primary Completion Date

December 2010

Eligibility Criteria

        Inclusion Criteria:

          -  neurosurgeon

          -  nurse

        Exclusion Criteria:

          -  none
      

Gender

All

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Cornelis J Drost, BS, MS, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT00651950

Organization ID

TSI-G-HYDRO-1C-H

Secondary IDs

2R44NS049680-02

Responsible Party

Sponsor

Study Sponsor

Transonic Systems Inc.

Collaborators

 National Institute of Neurological Disorders and Stroke (NINDS)

Study Sponsor

Cornelis J Drost, BS, MS, Principal Investigator, Transonic Systems Inc.


Verification Date

June 2012