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NCT04633785 Clinical Trial

Validation of Wrist Type Oscillometric Blood Pressure Monitorings

Blood Pressure Clinical Trial

Official title:
Validation of Wrist Type Oscillometric Blood Pressure Monitorings

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04633785
Other study ID # 2020-11-001CC
Secondary ID
Status Not yet recruiting
Phase
First received
Last updated
Start date December 1, 2020
Est. completion date June 30, 2021

Study information
Verified date November 2020
Source Taipei Veterans General Hospital, Taiwan
Contact Hao-Min Cheng, M.D., Ph.D.
Phone (886)-2-28757302
Email hmcheng@vghtpe.gov.tw
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Since the wrist devices have the advantage of being smaller, lighter, and more inexpensive than the upper arm devices, wrist devices become increasingly popular. However, it is of utmost importance to ensure that the BP measuring device can measure BP accurately. This study will be aimed to validate a wrist type oscillometric blood pressure monitoring with reference to the brachial blood pressure measured by auscultatory method with a mercury sphygmomanometer.

Description:

High blood pressure (BP) is one of the major cardiovascular risk factors in adults. Home blood pressure monitoring is superior to office-based measurements for prediction of the future development of cardiovascular diseases and is recommended by major guidelines. To monitor BP at home, patients can use devices that measure BP either at the arm or at the wrist. Among BP monitors, the wrist device is relatively easy to use, as the cuff can be used with one hand easily and correctly around the wrist than around the arm, and undressing is not necessary. Since the wrist devices have the advantage of being smaller, lighter, and more inexpensive than the upper arm devices, wrist devices become increasingly popular. However, it is of utmost importance to ensure that the BP measuring device can measure BP accurately. To make sure the performance of these devices, several guidelines have proposed protocols to validate these devices. This study will be aimed to validate a wrist type oscillometric blood pressure monitoring with reference to the brachial blood pressure measured by auscultatory method with a mercury sphygmomanometer.

Recruitment information / eligibility
Status Not yet recruiting
Enrollment 100
Est. completion date June 30, 2021
Est. primary completion date June 30, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 12 Years and older
Eligibility Inclusion Criteria: - above 12 years old Exclusion Criteria: - unclear Korotkoff sounds - wrist circumference outside of the designated range (13.5-23 cm) - arrhythmias

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No Intervention
There are no interventions in this study. The mercury sphygmomanometer and the wrist sphygmomanometer will be used in this study to collect blood pressure values from the study subjects.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Taipei Veterans General Hospital, Taiwan

Outcome
Type Measure Description Time frame Safety issue
Primary Validation The present study will be aimed to evaluate the accuracy of the wrist type oscillometric blood pressure monitorings. 7 months
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