Clinical trial NCT04082819: MediBeat - HeartBeat Observation Trial
Official title: Determining the Accuracy of the HeartBeat Algorithm for Calculating Blood Pressure
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Low Blood Pressure
Blood Pressure
High Blood Pressure
Hypertension
Hypotension
Lead sponsor: SE Health
Sponsor class: OTHER
Collaborators: name: Centre for Aging and Brain Health Innovation
First posted: 2019-09-09
Enrollment: 94
Sex: ALL
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Difference Between Systolic Manual Sphygmomanometer and Finger Pulse Oximeter Readings
timeFrame: 45 - 60 minutes
measure: Difference Between Diastolic Manual and Device Blood Pressure Readings
timeFrame: 45-60 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Markham
country: Canada
facility: SE Health
state: Ontario
Study officials:
affiliation: SE Health
name: Paul Holyoke, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.