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Validation of Wrist Type Oscillometric Blood Pressure Monitorings

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ClinicalTrials.gov Identifier: NCT04633785
Recruitment Status : Not yet recruiting
First Posted : November 18, 2020
Last Update Posted : November 18, 2020
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Study Description
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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.

Condition or disease Intervention/treatment
Blood Pressure Other: No Intervention

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.

Study Design
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Study Type : Observational
Estimated Enrollment : 100 participants
Observational Model: Other
Time Perspective: Cross-Sectional
Official Title: Validation of Wrist Type Oscillometric Blood Pressure Monitorings
Estimated Study Start Date : December 1, 2020
Estimated Primary Completion Date : June 30, 2021
Estimated Study Completion Date : June 30, 2021
Groups and Cohorts
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Group/Cohort Intervention/treatment
wrist BP 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.


Outcome Measures
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Primary Outcome Measures :
  1. Validation [ Time Frame: 7 months ]
    The present study will be aimed to evaluate the accuracy of the wrist type oscillometric blood pressure monitorings.


Eligibility Criteria
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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.
Criteria

Inclusion Criteria:

  • above 12 years old

Exclusion Criteria:

  • unclear Korotkoff sounds
  • wrist circumference outside of the designated range (13.5-23 cm)
  • arrhythmias
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04633785


Contacts
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Contact: Hao-Min Cheng, M.D., Ph.D. (886)-2-28757302 ext 307 hmcheng@vghtpe.gov.tw
Contact: Shu-Mei Yang, Ph.D (886)-2-55681049 ext 291 stellarsirius@gmail.com

Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan
Investigators
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Study Director: Hao-Min Cheng, M.D., Ph.D. Center for Evidence-based Medicine, Taipei Veterans General Hospital, Taiwan
More Information
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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT04633785    
Other Study ID Numbers: 2020-11-001CC
First Posted: November 18, 2020    Key Record Dates
Last Update Posted: November 18, 2020
Last Verified: November 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Veterans General Hospital, Taiwan:
oscillometric
wrist blood pressure monitor
sphygmomanometer