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| Sponsors and Collaborators: |
Transonic Systems Inc. Children's Hospital and Health System Foundation, Wisconsin Medical College of Wisconsin |
|---|---|
| Information provided by: | Transonic Systems Inc. |
| ClinicalTrials.gov Identifier: | NCT00651950 |
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: | Cohort, Cross-Sectional |
| Official Title: | A Flow Monitor for Pediatric Hydrocephalic Shunts - Bench Study of Sensor Alignment Accuracy and Repeatability |
| Estimated Enrollment: | 9 |
| Study Start Date: | November 2008 |
| Estimated Study Completion Date: | March 2009 |
| Estimated Primary Completion Date: | March 2009 (Final data collection date for primary outcome measure) |
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 |
Three neurosurgeons and six nurses
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: Bruce A Kaufman, MD | 414-266-6435 | bkaufman@mcw.edu |
| Contact: Sean M Lew, MD | 414-266-6435 | slew@mcw.edu |
| United States, Wisconsin | |
| Children's Hospital of Wisconsin | |
| Milwaukee, Wisconsin, United States, 53226 | |
| 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
| Responsible Party: | Transonic Systems Inc. ( Cornelis J. Drost, President & CEO, Transonic Systems Inc. ) |
| Study ID Numbers: | TSI-G-HYDRO-1C-H, 2 R44 NS049680-02 |
| Study First Received: | March 31, 2008 |
| Last Updated: | September 19, 2008 |
| ClinicalTrials.gov Identifier: | NCT00651950 |
| Health Authority: | United States: Institutional Review Board |
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Hydrocephalus shunt dysfunction shunt flow |
|
Pseudotumor cerebri Pseudotumor Cerebri Infant, Newborn, Diseases Central Nervous System Diseases |
Hydrocephalus Brain Diseases Intracranial Hypertension Hypertension |
|
Nervous System Diseases |
