Calibration of a Wrist Cuff Blood Pressure Device, According to the AAMI/ESH/ISO Universal Standard
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)
2 other identifiers
observational
200
1 country
1
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 an aneroid sphygmomanometer (reference device), as per the methodology described in the ISO 81060-2: AMD\_2020 protocol.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2021
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 28, 2021
CompletedFirst Posted
Study publicly available on registry
May 3, 2021
CompletedStudy Start
First participant enrolled
June 15, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2023
CompletedFebruary 21, 2023
February 1, 2023
2.5 years
April 28, 2021
February 17, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (4)
Systolic Pressure
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
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
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
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)
Study Arms (1)
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.
Interventions
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.
Eligibility Criteria
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.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cardiovascular Research New Brunswicklead
- Cloud DX Inc.collaborator
- Horizon Health Networkcollaborator
- New Brunswick Health Research Foundationcollaborator
- Dalhousie Universitycollaborator
Study Sites (1)
Horizon Health Network
Saint John, Canada
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Martin MacKinnon, MD, FRCP(C)
Complicated Hypertension Clinic, Saint John Regional Hospital
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 28, 2021
First Posted
May 3, 2021
Study Start
June 15, 2021
Primary Completion
December 31, 2023
Study Completion
December 31, 2023
Last Updated
February 21, 2023
Record last verified: 2023-02