MediBeat - HeartBeat Observation Trial

Hypertension Clinical Trial

Official title:

Determining the Accuracy of the HeartBeat Algorithm for Calculating Blood Pressure

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04082819
• Other study ID #: MCD307-007-1920
• Status: Completed
• Phase: N/A
• Start date: October 4, 2019
• Est. completion date: December 17, 2019

Study information

• Verified date: March 2020
• Source: SE Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 94
• Est. completion date: December 17, 2019
• Est. primary completion date: November 22, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure
• High Blood Pressure
• Hypertension
• Hypotension
• Low Blood Pressure

Intervention

Device:
• Contec CMS50EW
Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.
• Sphygmomanometer
Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit.

Locations

Country	Name	City	State
Canada	SE Health	Markham	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
SE Health	Centre for Aging and Brain Health Innovation

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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