Blood Pressure Clinical Trial
Official title:
CareTaker Self-Calibration Validation
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.
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.
;
Observational Model: Cohort, Time Perspective: Retrospective
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