Clinical Trial of YuWell YE660D Blood Pressure Monitor in General Population According to the ISO 81060-2:2018

The purpose of this study is to evaluate the accuracy of the YuWell YE660D oscillometric upper-arm blood pressure monitor for clinic and home in general population according to the Association for the Advancement of Medical Instrumentation/European Society of Hypertension/International Organization for Standardization (AAMI/ESH/ISO) Universal Standard (ISO 81060-2:2018).

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Key information

Conditions

Blood Pressure

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210011, China

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

12 Years and older;
Subjects voluntarily participate in the clinical trial and sign the informed consent.

Exclusion criteria

Disturbance of consciousness;
Patients requiring hemodialysis;
Taking anticoagulant drugs due to cardiovascular and cerebrovascular diseases;
Pregnant and lactating women;
Patients with cardiac arrhythmias;
Other conditions that the investigator considers ineligible for clinical trial.

Treatment and study plan

YuWell YE660D Electronic Sphygmomanometer

Diagnostic Test

Measurement blood pressure by YuWell YE660D Electronic Sphygmomanometer and Desk Mercury Sphygmomanometer

Primary outcomes

Blood pressure measurement data

Time frame: 30 minutes

Systolic Pressure and Diastolic Pressure

Sponsors and collaborators

Lead sponsor

The Second Hospital of Nanjing Medical University

Other

Collaborators

Jiangsu Yuyue medical equipment & supply Co., Ltd.

Registry information

Official study title

Validation of the YuWell YE660D Oscillometric Upper-arm Blood Pressure Monitor for Clinic and Home in General Population According to the AAMI/ESH/ISO Universal Standard (ISO 81060-2:2018)

Important dates

Study start: 2021
Primary completion: 2022
Study completion: 2022
First posted: Jun 18, 2021
Registry last updated: Mar 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed