Hypertension Clinical Trial
Official title:
Determining the Accuracy of the HeartBeat Algorithm for Calculating Blood Pressure
The goal of the study was to compare the current gold standard blood pressure instrument (a mercury-filled sphygmomanometer with cuff and stethoscope) with the new experimental algorithm developed by HeartBeat Technologies Ltd. To that end, participants were recruited from Markham, Ontario and participated in a series of alternating blood pressure measurements over a period of 45 minutes. Comparisons were made between manual measurements and device measurements to determine the quality of the device readings. Measurements were taken by trained nurses and staff were consistent across the study duration.
The gold standard instrument for blood pressure measurement is a mercury-filled
sphygmomanometer with cuff and stethoscope (Canadian Agency for Drugs and Technologies in
Health; Canadian Electronic Library, 2012). However, such a device is not the most convenient
for client self-monitoring or virtual (remote) care. Thus, there is a desire for an accurate,
reliable alternative for the traditional mercury-containing sphygmomanometer.
HeartBeat Technologies Ltd. ("Heartbeat") has developed a novel approach to measuring blood
pressure after an initial blood pressure reading using the conventional measurement method,
supplemented by specific characteristics of a person (age, gender, height, weight, and heart
rate), has established a "baseline measurement" for the person. The "novel approach" uses a
finger pulse oximeter, the Contec CMS50EW device (Figure 1) (manufactured by Contec Medical
Systems Co., Ltd., Shanghai, People's Republic of China). The finger pulse oximeter detects
the changes in blood volume directly below the person's skin and indirectly measures oxygen
saturation in the blood. The measurement is in the form of a photoplethysmogram (PPG) which
is captured by the Contec oximeter and then, by Bluetooth technology, transmitted to a
smartphone or tablet. A HeartBeat application, called MediBeat, on the smartphone or tablet
then transmits the PPG to a server where a proprietary algorithm analyzes the baseline
measurement for the person and the PPG to calculate the person's current blood pressure.
Heartbeat's intent is that the current blood pressure reading would then be made available to
both the client and the health provider through separate web-based interfaces. Providers
would be able to log onto the HeartBeat web-based application from anywhere to review and
monitor the blood pressure of multiple clients, while clients can log onto the application to
track their own measurements.
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