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

February 17, 2023 updated by: Cardiovascular Research New Brunswick

Calibration of the Cloud DX Pulsewave Health Monitor (PAD-2A) Oscillometric Wrist Cuff Home Blood Pressure Monitor, According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2: AMD_2020) (CCV-4)

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 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.

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
      • Saint John, Canada
        • Recruiting
        • Horizon Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

For this study, we will recruit and consent approximately 200 adult male and female patient participants (≥ 19 years of age; minimum 30% male/female) who are referred to the Complicated Hypertension Clinic at the Saint John Regional Hospital (SJRH) and non-patient participants who are willing to volunteer to consent to participate in the study. Eligibility of participants for this study is based on the inclusion and exclusion criteria as per the ISO 81060-2: AMD_2020 protocol, as described below.

Description

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 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 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Only
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Outpatients Complicated Hypertension Clinic
This study population consists of approximately 200 adult male and female participants (≥ 19 years of age; minimum 30% male/female). Participants will be recruited from eligible patients who are referred to the Complicated Hypertension Clinic at the Saint John Regional Hospital (SJRH) as well as non-patient participants who are willing to volunteer to consent to participate in the study.
Device: Pulsewave Health Monitor (PAD-2A) Device
This is an observational, comparison study of blood pressure measurements. 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 auscultatory blood pressure measurements via an aneroid sphygmomanometer (reference device), as per the ISO 81060-2: AMD_2020 universal protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Systolic Pressure
Time Frame: From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds)
Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff blood pressure device (mmHg)
From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds)
Systolic Pressure
Time Frame: From the start of manual inflation of the upper arm blood pressure cuff to the end of (manual) deflation of the upper arm blood pressure cuff (approximately 30-60 seconds)
Simultaneous auscultatory blood pressure measurements by 2 trained observers
From the start of manual inflation of the upper arm blood pressure cuff to the end of (manual) deflation of the upper arm blood pressure cuff (approximately 30-60 seconds)
Diastolic Pressure
Time Frame: From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds)
Non-invasive Pulsewave Health Monitor (PAD-2A) wrist cuff blood pressure device (mmHg)
From the start of cuff inflation to the end of cuff deflation (approximately 60 seconds)
Diastolic Pressure
Time Frame: From the start of manual inflation of the upper arm blood pressure cuff to the end of (manual) deflation of the upper arm blood pressure cuff (approximately 30-60 seconds)
Simultaneous auscultatory blood pressure measurements by 2 trained observers
From the start of manual inflation of the upper arm blood pressure cuff to the end of (manual) deflation of the upper arm blood pressure cuff (approximately 30-60 seconds)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cardiovascular Research New Brunswick

Collaborators

Dalhousie University
Horizon Health Network
Cloud DX Inc.
New Brunswick Health Research Foundation

Investigators

  • Principal Investigator: Martin MacKinnon, MD, FRCP(C), Complicated Hypertension Clinic, Saint John Regional Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 15, 2021

Primary Completion (Anticipated)

December 31, 2023

Study Completion (Anticipated)

December 31, 2023

Study Registration Dates

First Submitted

April 28, 2021

First Submitted That Met QC Criteria

April 28, 2021

First Posted (Actual)

May 3, 2021

Study Record Updates

Last Update Posted (Estimate)

February 21, 2023

Last Update Submitted That Met QC Criteria

February 17, 2023

Last Verified

February 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RS#: 2021-3003; R#: 101246
  • STP-PW2-002 (Other Identifier: Health Canada)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

Currently, the clinical research group is undecided regarding individual participant data (IDP) sharing with other researchers upon completion of this study, although it is acknowledged that the practice of data sharing among scientists, clinicians, and other professionals is of increasing importance, particularly for transparency in clinical research studies.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hypertension

Clinical Trials on Pulsewave Health Monitor (PAD-2A) Device

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Malawi

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe