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

Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age12+
SponsorThe First Affiliated Hospital of Anhui Medical University

About this trial

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.

Eligibility criteria

Qualifiers

Both sexes; at least 30% of the subjects are male and at least 30% of the subjects are female.

Subject's age > 12 years.

At least 20% of the subjects should have arm circumference within each quarter interval of the total arm circumference range;

At least 10% of the subjects should have arm circumference within the upper one-eighth interval of the total arm circumference range;

Disqualifiers

None

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

85 Participants
are grouped into 2 trial groups