Status:
UNKNOWN
Calibration of a Wrist Cuff Blood Pressure Device, According to the AAMI/ESH/ISO Universal Standard
Lead Sponsor:
Cardiovascular Research New Brunswick
Collaborating Sponsors:
Cloud DX Inc.
Horizon Health Network
Conditions:
Hypertension
Eligibility:
All Genders
19+ years
Brief Summary
The objective of this study is to calibrate the blood pressure measurements of the Pulsewave Health Monitor (PAD-2A) device to be within 5±8 mmHg of the average of the dual-observer measurements via a...
Detailed Description
The plan for this study is to calibrate the blood pressure measurements of the PAD-2A device with the dual-observer blood pressure measurements via an aneroid sphygmomanometer (reference device), as p...
Eligibility Criteria
Inclusion
- Adults ≥ 19 years of age (minimum 30% male/female)
- Wrist circumference between 13.5 cm. - 23 cm. (5.3 in. - 9.1 in.):
- Specifically for this test device, the wrist size of the consented participants will be distributed accordingly for a Gaussian distribution:
- Lowest Octile: ≥ 13.5cm to \< 14.7cm Lower Quarter: ≥ 13.5cm to \< 15.9cm Lower-Middle Quarter: ≥ 15.9cm to \< 18.3cm Upper-Middle Quarter: ≥ 18.3cm to \< 20.7cm Upper Quarter: ≥ 20.7cm to ≤ 23.0cm Highest Octile: ≥ 21.9cm to ≤ 23.0cm
- ● Willing to volunteer to participate and to sign the study specific informed consent form
Exclusion
- Wrist circumference less than 13.5 cm. (5.3 in.) or greater than 23 cm. (9.1 in)
- Hand or body tremors
- Irregular heart rhythm (bigeminy, trigeminy, isolated ventricular premature beat (VPB), atrial fibrillation)
- Korotkoff sound K5 not audible
- Pregnant
- A musculoskeletal disorder that prevents a non-invasive device to be inflated/deflated on the arm
- Unwilling to volunteer to participate and to sign the study specific informed consent form
Key Trial Info
Start Date :
June 15 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2023
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT04869826
Start Date
June 15 2021
End Date
December 31 2023
Last Update
February 21 2023
Active Locations (1)
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1
Horizon Health Network
Saint John, Canada