Clinical trial NCT04633785: Validation of Wrist Type Oscillometric Blood Pressure Monitorings
Official title: Validation of Wrist Type Oscillometric Blood Pressure Monitorings
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Blood Pressure
Keywords: oscillometric
wrist blood pressure monitor
sphygmomanometer
Lead sponsor: Taipei Veterans General Hospital, Taiwan
Sponsor class: OTHER_GOV
First posted: 2020-11-18
Enrollment: 100
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients will be recruited from outpatient clinics at Taipei Veterans General Hospital from 2020 to 2021. A total of 100 subjects will be enrolled in the study, and informed consent forms will be obtained from before measurements. In accordance with the ANSI/AAMI/ISO, subjects will be screened to ensure that sex, age, wrist circumference, and BP readings fulfilled the participation requirements described in those protocols. If subjects aged less than 12 years old, having wrist circumference outside of the designated range (13.5-23 cm), having arrhythmias, who moved their arms or bodies during the BP measurements, and have unclear Korotkoff sounds will be excluded from this study.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

* above 12 years old

Exclusion Criteria:

* unclear Korotkoff sounds
* wrist circumference outside of the designated range (13.5-23 cm)
* arrhythmias

Primary outcomes:
measure: Validation
timeFrame: 7 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Center for Evidence-based Medicine, Taipei Veterans General Hospital, Taiwan
name: Hao-Min Cheng, M.D., Ph.D.
role: STUDY_DIRECTOR
References: