CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 94 enrolled
Drug / intervention
Contec CMS50EW +1 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04082819
NCT04082819N/ACompleted

Determining the Accuracy of the HeartBeat Algorithm for Calculating Blood Pressure

SE Health·interventional·Posted Sep 9, 2019·Updated Apr 1, 2020

In Brief

A clinical study evaluating Contec CMS50EW and Sphygmomanometer for Low Blood Pressure and 4 related conditions. Completed, enrolled 94 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 9, 2019
Enrollment StartOct 4, 2019
Primary CompletionNov 22, 2019
Study CompletionDec 17, 2019
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 6.8 years ago

Interventions

Contec CMS50EWdevice

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

Sphygmomanometerdevice

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