Clinical Trial on the Accuracy of Blood Pressure Measurement by YE990 Medical Automatic Electronic Sphygmomanometer

This study was a single-center, open-ended, self-controlled clinical study . Same armsequential method was used to measure the blood pressure of the subjects，inclusion of ≥85 subjects aged 12 years or older who met the enrollment criteria.In accordance with 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/Amd 1:2020)",the purpose of this study was to compare the blood pressure and pulse rate measured by an electronic sphygmomanometer with those measured by a reference sphygmomanometer (an upper-arm noninvasive auscultatory sphygmomanometer) and by palpation of the radial artery, and then to evaluate the accuracy and safety of the measurement of systolic blood pressure, diastolic blood pressure, and pulse rate by a fully automated electronic sphygmomanometer for medical use (Model No. YE990), which is manufactured by Jiangsu Yuyue Medical Equipment Co.

NCT Number	NCT06565702
Lead Sponsor	The First Affiliated Hospital of Anhui Medical University
Conditions	Blood Pressure
Enrollment	85 participants
Start Date	2024-08-20
Primary Completion	2025-08-20 (estimated)
Study Completion	2025-12-30 (estimated)
Updated on ClinicalTrials.gov	2024-08-22