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

Blood Pressure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04238442
• Other study ID #: Pro00079695
• Status: Completed
• Phase: N/A
• Start date: August 14, 2019
• Est. completion date: February 5, 2020

Study information

• Verified date: April 2020
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 121
• Est. completion date: February 5, 2020
• Est. primary completion date: February 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Blood Pressure

Intervention

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).

Locations

Country	Name	City	State
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	A&D Medical

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy per International Standards Organization Protocol	Agreement of the device to mercury auscultation.	3 months