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

Last updated: February 17, 2023
Sponsor: Cardiovascular Research New Brunswick
Overall Status: Active - Recruiting

Phase

N/A

Condition

Williams Syndrome

Stress

Vascular Diseases

Treatment

N/A

Clinical Study ID

NCT04869826
RS#: 2021-3003; R#: 101246
STP-PW2-002
  • Ages > 19
  • All Genders
  • Accepts Healthy Volunteers

Study 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 an aneroid sphygmomanometer (reference device), as per the methodology described in the ISO 81060-2: AMD_2020 protocol.

Eligibility Criteria

Inclusion

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.): Specifically for this test device, the wrist size of the consented participants will bedistributed accordingly for a Gaussian distribution: Lowest Octile: ≥ 13.5cm to < 14.7cm Lower Quarter: ≥ 13.5cm to < 15.9cm Lower-MiddleQuarter: ≥ 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

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/deflatedon the arm
  • Unwilling to volunteer to participate and to sign the study specific informed consentform

Study Design

Total Participants: 200
Study Start date:
June 15, 2021
Estimated Completion Date:
December 31, 2023

Study 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 5±8 mmHg of the average of the dual-observer auscultatory blood pressure measurements by adjusting the device algorithm.

Connect with a study center

  • Horizon Health Network

    Saint John,
    Canada

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.