Calibration of a Wrist Cuff Blood Pressure Device According to the AAMI/ESH/ISO Universal Standard

  • STATUS
    Recruiting
  • End date
    Jun 30, 2022
  • participants needed
    200
  • sponsor
    Cardiovascular Research New Brunswick
Updated on 16 August 2021

Summary

The objective of this study is to calibrate the blood pressure measurements of the Pulsewave Health Monitor (PAD-2A) device to be within 58 mmHg of the average of the dual-observer measurements via an aneroid sphygmomanometer (reference device), as per the methodology described in the ISO 81060-2: AMD_2020 protocol.

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 per the ISO 81060-2: AMD_2020 protocol. The data will be collected and analyzed in order to calibrate the PAD-2A device blood pressure measurements to be within 58 mmHg of the average of the dual-observer auscultatory blood pressure measurements by adjusting the device algorithm.

Details
Condition Vascular Diseases, Hypertension, Elevated Blood Pressure, high blood pressure, arterial hypertension
Treatment Pulsewave Health Monitor (PAD-2A) Device
Clinical Study IdentifierNCT04869826
SponsorCardiovascular Research New Brunswick
Last Modified on16 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Adults 19 years of age (minimum 30% male/female)
Wrist circumference between 13.5 cm. - 23 cm. (5.3 in. - 9.1 in.)
At least 20% of total participants, greater than 20.6 cm
At least 20% of total participants, between 18.3 cm. & 20.6 cm
At least 20% of total participants, between 15.9 cm. & 18.3 cm
At least 20% of total participants, less than 15.9 cm
At least 10% of total participants, greater than 21.8 cm
At least 10% of total participants, less than 14.7 cm
Willing to volunteer to participate and to sign the study specific informed consent form

Exclusion Criteria

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
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