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

Nanjing Medical University

Status: Completed

Conditions: Blood Pressure

Treatments: Diagnostic Test: YuWell YE660D Electronic Sphygmomanometer

Study type: Interventional

Funder types: Other

Identifiers

NCT04931264

YUWELL-YLQX202101

Details and patient eligibility

About

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).

Enrollment: 92 patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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92 participants in 1 patient group

YuWell YE660D and mercury sphygmomanometer

Experimental group

Description:

Blood Pressure Measurement with the YuWell YE660D Electronic Sphygmomanometer (YuWell YE660D) and with Desk Mercury Sphygmomanometer.

Treatment:

Diagnostic Test: YuWell YE660D Electronic Sphygmomanometer