Assessing the Accuracy of the A&D TM-2657W Oscillometric Device

The A&D automatic blood pressure device is a new kiosk that can measure blood pressure in the general population.

The investigators plan to use the existing International Standards Organization validation protocol to determine whether this device measures blood pressure accurately.

Study Overview

• Status: Completed
• Conditions: Blood Pressure
• Intervention / Treatment: Device: A&D TM-2657W oscillometric device

Detailed Description

Methods and Analysis

Study methodology will follow the ISO protocol:

• 85 adult (age 18 years or greater) subjects will be included (it is estimated that approximately 140 subjects will need to be screened as some will be ineligible). 85 is the recommended sample size for validation studies using the ISO protocol.
• Subjects will be recruited via an existing registry of over 250 individuals that have participated in past measurement studies, through advertisements, and from the University of Alberta Hypertension Clinic.
• Specific requirements for a certain percentage of subjects with specific age, sex, upper arm circumference, and baseline blood pressure levels will be observed to ensure that a representative sample is studied (according to the ISO standards).
• Subjects that are pregnant or with atrial fibrillation will be excluded. Blood pressure measurements will be taken using recommended, optimal technique.
• Nine measurements will be taken in each subject, alternating between blinded two-observer auscultation with a mercury-based sphygmomanometer (the reference standard) and the TM-2657. Careful attention will be paid to ensuring proper cuffing. The first two measurements will be discarded and the latter seven measurements (4 auscultatory and TM-2657 measurements) will be used in the analysis, which will be conducted according to ISO standards.
• Accuracy will be assessed according to Criterion 1 and 2 of the ISO standard. Bland-Altman plots will be generated. A plot of measurement error versus arm circumference will be generated as well.

• Study Type: Interventional
• Enrollment (Actual): 121
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Edmonton, Alberta, Canada
      • University of Alberta

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 18 years of age or older
• normal sinus rhythm
• have capacity to give consent
• following the International Standards Organization criteria for: gender distribution, limb size, blood pressure distribution

Exclusion Criteria:

• atrial fibrillation
• pregnancy

Study Plan

How is the study designed?

Design Details

• Primary Purpose: DIAGNOSTIC
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: BP oscillometric measurement; Oscillometric BP measurement	Device: A&D TM-2657W oscillometric device; Assessing the accuracy of the A&D TM-2657W oscillometric device using International Standards Organization validation protocol. This involves comparing the accuracy of the A&D device to 2 observer mercury auscultation (gold standard).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Accuracy per International Standards Organization Protocol	Agreement of the device to mercury auscultation.	3 months

Collaborators and Investigators

• Sponsor: University of Alberta
• Collaborators: A&D Medical
• Investigators: Principal Investigator: Jennifer Ringrose, MD, University of Alberta

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 14, 2019
• Primary Completion (ACTUAL): February 5, 2020
• Study Completion (ACTUAL): February 5, 2020

Study Registration Dates

• First Submitted: October 1, 2019
• First Submitted That Met QC Criteria: January 22, 2020
• First Posted (ACTUAL): January 23, 2020

Study Record Updates

• Last Update Posted (ACTUAL): April 10, 2020
• Last Update Submitted That Met QC Criteria: April 9, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: Pro00079695

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No