Trial Outcomes & Findings for MediBeat - HeartBeat Observation Trial (NCT NCT04082819)
NCT ID: NCT04082819
Last Updated: 2020-04-01
Results Overview
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.
COMPLETED
NA
94 participants
45 - 60 minutes
2020-04-01
Participant Flow
Healthy participants who were 25 years old and worked in Markham were recruited. Only healthy subjects were included; those who were under 25, had 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 were excluded.
Participant milestones
| Measure |
Low Blood Pressure
Low blood pressure (systolic: 0-129, diastolic: 0-79)
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.
|
Medium Blood Pressure
Medium blood pressure (systolic: 130-160, diastolic: 80-100)
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.
|
High Blood Pressure
High blood pressure (systolic: 161 or higher, diastolic: 101 or higher)
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.
|
|---|---|---|---|
|
Overall Study
STARTED
|
37
|
54
|
3
|
|
Overall Study
COMPLETED
|
37
|
54
|
3
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
Low Blood Pressure
n=37 Participants
Low blood pressure (systolic: 0-129, diastolic: 0-79)
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.
|
Medium Blood Pressure
n=54 Participants
Medium blood pressure (systolic: 130-160, diastolic: 80-100)
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.
|
High Blood Pressure
n=3 Participants
High blood pressure (systolic: 161 or higher, diastolic: 101 or higher)
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.
|
Total
n=94 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
40.1 years
STANDARD_DEVIATION 10.1 • n=37 Participants
|
44.2 years
STANDARD_DEVIATION 10.6 • n=54 Participants
|
48.0 years
STANDARD_DEVIATION 12.2 • n=3 Participants
|
42.7 years
STANDARD_DEVIATION 10.5 • n=94 Participants
|
|
Sex: Female, Male
Female
|
32 Participants
n=37 Participants
|
31 Participants
n=54 Participants
|
2 Participants
n=3 Participants
|
65 Participants
n=94 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=37 Participants
|
23 Participants
n=54 Participants
|
1 Participants
n=3 Participants
|
29 Participants
n=94 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
PRIMARY outcome
Timeframe: 45 - 60 minutesPopulation: The overall participants analyzed indicate the number of individuals who matched the ranges listed in the description for low, medium or high blood pressure categories, where they had blood pressure ranges falling between the respective values indicated for the systolic pressure measured.
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.
Outcome measures
| Measure |
Low Blood Pressure
n=37 Participants
Systolic score between 90 - 120mmHg.
|
Medium Blood Pressure
n=54 Participants
Systolic score between 130 - 160mmHg.
|
High Blood Pressure
n=3 Participants
Systolic score greater than 161mmHg.
|
|---|---|---|---|
|
Difference Between Systolic Manual Sphygmomanometer and Finger Pulse Oximeter Readings
|
3 mmHg
Standard Deviation 6
|
3 mmHg
Standard Deviation 6
|
11 mmHg
Standard Deviation 10
|
PRIMARY outcome
Timeframe: 45-60 minutesPopulation: The overall participants analyzed indicate the number of individuals who matched the ranges listed in the description for low, medium or high blood pressure categories, where they had blood pressure ranges falling between the respective values indicated for the diastolic pressure measured.
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.
Outcome measures
| Measure |
Low Blood Pressure
n=37 Participants
Systolic score between 90 - 120mmHg.
|
Medium Blood Pressure
n=54 Participants
Systolic score between 130 - 160mmHg.
|
High Blood Pressure
n=3 Participants
Systolic score greater than 161mmHg.
|
|---|---|---|---|
|
Difference Between Diastolic Manual and Device Blood Pressure Readings
|
1 mmHg
Standard Deviation 4
|
0 mmHg
Standard Deviation 6
|
3 mmHg
Standard Deviation 4
|
Adverse Events
Low Blood Pressure
Medium Blood Pressure
High Blood Pressure
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place