MediBeat - HeartBeat Observation Trial

NCT ID: NCT04082819

Last Updated: 2020-04-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 94 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-04
• Study Completion Date: 2019-12-17

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.

Conditions

Low Blood Pressure; Blood Pressure; High Blood Pressure; Hypertension; Hypotension

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: DOUBLE

Study Groups

Low Blood Pressure

Low blood pressure (systolic: 0-129, diastolic: 0-79)

Group Type: OTHER

Contec CMS50EW

Intervention Type: DEVICE

Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.

Sphygmomanometer

Intervention Type: DEVICE

Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit.

Medium Blood Pressure

Medium blood pressure (systolic: 130-160, diastolic: 80-100)

Group Type: OTHER

Contec CMS50EW

Intervention Type: DEVICE

Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.

Sphygmomanometer

Intervention Type: DEVICE

Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit.

High Blood Pressure

High blood pressure (systolic: 161 or higher, diastolic: 101 or higher)

Group Type: OTHER

Contec CMS50EW

Intervention Type: DEVICE

Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.

Sphygmomanometer

Intervention Type: DEVICE

Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit.

Interventions

Contec CMS50EW

Participants' blood pressure will be measured 3 times with the wearable finger pulse oximeter at their study visit.

Intervention Type: DEVICE

Sphygmomanometer

Participants' blood pressure will be measured 4 times manually with a blood pressure cuff at their study visit.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 25 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Centre for Aging and Brain Health Innovation

OTHER

Sponsor Role: collaborator

SE Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul Holyoke, PhD

Role: PRINCIPAL_INVESTIGATOR

SE Health

Locations

SE Health

Markham, Ontario, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 33890856 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

MCD307-007-1920

Identifier Type: -

Identifier Source: org_study_id