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

This study has been withdrawn prior to enrollment.
(Withdrawn due to lack of enrollment.)
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Transonic Systems Inc.
ClinicalTrials.gov Identifier:
NCT00651950
First received: March 31, 2008
Last updated: June 4, 2012
Last verified: June 2012
  Purpose

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.


Condition
Hydrocephalus

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: A Flow Monitor for Pediatric Hydrocephalic Shunts - Bench Study of Sensor Alignment Accuracy and Repeatability

Resource links provided by NLM:


Further study details as provided by Transonic Systems Inc.:

Primary Outcome Measures:
  • Standard deviation of error between operator-measured flow measurements and actual flow measurements. [ Time Frame: Daily and weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Flow measurement accuracy vs. the number of times the measurement is conducted. [ Time Frame: Daily, weekly ] [ Designated as safety issue: No ]

Enrollment: 0
Study Start Date: March 2009
Study Completion Date: December 2010
Primary Completion Date: December 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Operator Dependence

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Three neurosurgeons and six nurses

Criteria

Inclusion Criteria:

  • neurosurgeon
  • nurse

Exclusion Criteria:

  • none
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00651950

Locations
United States, Wisconsin
Children's Hospital of Wisconsin
Milwaukee, Wisconsin, United States, 53226
Sponsors and Collaborators
Transonic Systems Inc.
Investigators
Principal Investigator: Cornelis J Drost, BS, MS Transonic Systems Inc.
Study Director: Bruce A Kaufman, MD Children's Hospital and Health System Foundation, Wisconsin
  More Information

No publications provided

Responsible Party: Transonic Systems Inc.
ClinicalTrials.gov Identifier: NCT00651950     History of Changes
Other Study ID Numbers: TSI-G-HYDRO-1C-H, 2R44NS049680-02
Study First Received: March 31, 2008
Last Updated: June 4, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Transonic Systems Inc.:
Hydrocephalus
shunt dysfunction
shunt flow

Additional relevant MeSH terms:
Hydrocephalus
Brain Diseases
Central Nervous System Diseases
Intracranial Hypertension
Nervous System Diseases

ClinicalTrials.gov processed this record on November 25, 2014