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

Not Applicable
Completed
Conditions
Blood Pressure
Interventions
Diagnostic Test: YuWell YE660D Electronic Sphygmomanometer
Registration Number
NCT04931264
Lead Sponsor
The Second Hospital of Nanjing Medical University
Brief Summary

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).

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
92
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.

Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
YuWell YE660D and mercury sphygmomanometerYuWell YE660D Electronic SphygmomanometerBlood Pressure Measurement with the YuWell YE660D Electronic Sphygmomanometer (YuWell YE660D) and with Desk Mercury Sphygmomanometer.
Primary Outcome Measures
NameTimeMethod
Blood pressure measurement data30 minutes

Systolic Pressure and Diastolic Pressure

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

The Second Affiliated Hospital of Nanjing Medical University

🇨🇳

Nanjing, Jiangsu, China

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