MediBeat - HeartBeat Observation Trial

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Determining the Accuracy of the HeartBeat Algorithm for Calculating Blood Pressure

Conditions
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Low Blood Pressure, Blood Pressure, High Blood Pressure, Hypertension, Hypotension

Intervention / Treatment
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* Device: Contec CMS50EW
* Device: Sphygmomanometer


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: adult over 25 years of age Exclusion Criteria: those who have heart arrhythmias, atrial fibrillations or atrial flutters, an inaudible Korotkoff sound, wounds of the upper arms/wrists, missing fingers, and/or an arm circumference of more than 55 cm will be excluded

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low Blood Pressure<br>Low blood pressure (systolic: 0-129, diastolic: 0-79) | Device: Contec CMS50EW<br>* Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.<br>Device: Sphygmomanometer<br>* Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit.<br>|
| Other: Medium Blood Pressure<br>Medium blood pressure (systolic: 130-160, diastolic: 80-100) | Device: Contec CMS50EW<br>* Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.<br>Device: Sphygmomanometer<br>* Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit.<br>|
| Other: High Blood Pressure<br>High blood pressure (systolic: 161 or higher, diastolic: 101 or higher) | Device: Contec CMS50EW<br>* Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.<br>Device: Sphygmomanometer<br>* Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference Between Systolic Manual Sphygmomanometer and Finger Pulse Oximeter Readings | Each device reading was compared to the manual blood pressure reading taken before (R1) and after it (R2). The degree of alignment for systolic blood pressure was calculated by taking the difference between the two scores (manual and device). The reading with the best alignment was used. | 45 - 60 minutes | 
| Difference Between Diastolic Manual and Device Blood Pressure Readings | Each device reading was compared to the manual reading before (R1) and after (R2) it, to calculate the degree of alignment. The difference of the device and R1, and the device and R2 were taken. The smaller number was used for results reporting. | 45-60 minutes |