CareTaker Self-Calibration Validation (Self_Cal)
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|ClinicalTrials.gov Identifier: NCT02831777|
Recruitment Status : Completed
First Posted : July 13, 2016
Last Update Posted : July 13, 2016
The goal of the study is to test the capability of the CareTaker monitor to calibrate its continuous blood pressure readings independently. Currently the device requires another approved blood pressure monitor to provide a starting calibration.
The new control module enables the CareTaker to perform a pressure sweep of the internal pressure in the finger cuff. The resulting data is analyzed using a combination of pulse analysis/oscillometry approach.
|Condition or disease||Intervention/treatment|
|Blood Pressure||Device: non-invasive blood pressure monitor|
The specific objective of this project was to demonstrate the CareTaker's ability to perform self-calibration to the same performance standard as its predicate device. That device demonstrated efficacy by showing substantial equivalence to the performance of classical sphygmomanometry using a Riva-Rocci/Korotkoff (RRK) measurement on the brachial artery, meeting a bias of at least 5 mmHg and a standard deviation of 8 mmHg across 3 paired readings from at least 85 patients, for a total of at least 255 paired readings.
The study was performed at the University of Virginia Medical Center in Charlottesville, Virginia. UVA's Institutional Review Board approved (#18686) and supervised the study for subjects who were University of Virginia hospital patients and staff > 18 years of age and who were able to give verbal consent.
|Study Type :||Observational|
|Actual Enrollment :||140 participants|
|Official Title:||CareTaker Self-Calibration Validation|
|Study Start Date :||March 2016|
|Actual Primary Completion Date :||May 2016|
|Actual Study Completion Date :||May 2016|
- Device: non-invasive blood pressure monitor
Equivalence of CareTaker blood pressure to classical sphygmomanometry
- Performance comparison [ Time Frame: 8 minutes for 3 paired readings ]Comparison with performance of classical sphygmomanometry using a Riva-Rocci/Korotkov (RRK) measurement on the brachial artery, meeting a bias of at least 5 mmHg and a standard deviation of 8 mmHg
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02831777
|Principal Investigator:||Martin C Baruch, PhD||CareTaker Medical LLC|