N/A
Completed N=94
MediBeat - HeartBeat Observation Trial
Low Blood Pressure · Blood Pressure · High Blood Pressure · Hypertension
Source: ClinicalTrials.gov NCT04082819 ↗
Enrolled (actual)
94
Serious AEs
0.0%
Results posted
Apr 2020
Primary outcomePrimary: Difference Between Systolic Manual Sphygmomanometer and Finger Pulse Oximeter Readings — 3; 3; 11 mmHg
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Difference Between Systolic Manual Sphygmomanometer and Finger Pulse Oximeter Readings |
3; 3; 11 | — |
| PRIMARY Difference Between Diastolic Manual and Device Blood Pressure Readings |
1; 0; 3 | — |
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
Data sourced from ClinicalTrials.gov (NCT04082819). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.