MediBeat - HeartBeat Observation Trial

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.

Study Overview

• Status: Completed
• Conditions: Hypertension; Blood Pressure; Hypotension; High Blood Pressure; Low Blood Pressure
• Intervention / Treatment: Device: Contec CMS50EW; Device: Sphygmomanometer

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 94
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Markham, Ontario, Canada, L3R 6H3
      • SE Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

3

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: SE Health
• Collaborators: Centre for Aging and Brain Health Innovation
• Investigators: Principal Investigator: Paul Holyoke, PhD, SE Health

Publications and helpful links

General Publications

• Holyoke P, Yogaratnam K, Kalles E. Web-Based Smartphone Algorithm for Calculating Blood Pressure From Photoplethysmography Remotely in a General Adult Population: Validation Study. J Med Internet Res. 2021 Apr 23;23(4):e19187. doi: 10.2196/19187.

Study record dates

Study Major Dates

• Study Start (Actual): October 4, 2019
• Primary Completion (Actual): November 22, 2019
• Study Completion (Actual): December 17, 2019

Study Registration Dates

• First Submitted: September 4, 2019
• First Submitted That Met QC Criteria: September 6, 2019
• First Posted (Actual): September 9, 2019

Study Record Updates

• Last Update Posted (Actual): April 1, 2020
• Last Update Submitted That Met QC Criteria: March 17, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Hypotension
• Other Study ID Numbers: MCD307-007-1920

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes