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NCT06565702

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

Sponsor: The First Affiliated Hospital of Anhui Medical University

View on ClinicalTrials.gov

Summary

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.

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

OBSERVATIONAL

Enrollment

Start Date

2024-08-20

Completion Date

2025-12-30

Last Updated

2024-08-22

Healthy Volunteers

Conditions

Blood Pressure

Inclusion Criteria: Subjects should meet all of the following requirements for inclusion in the study: 1. Both sexes; at least 30% of the subjects are male and at least 30% of the subjects are female. 2. Subject's age \> 12 years. 3. Arm circumference distribution: 1. At least 20% of the subjects should have arm circumference within each quarter interval of the total arm circumference range; 2. At least 10% of the subjects should have arm circumference within the upper one-eighth interval of the total arm circumference range; 3. At least 10% of the subjects shall have an arm circumference within the lower one-eighth interval of the total arm circumference range. 4. Blood pressure distribution: 1. At least 5% of subjects shall have a systolic blood pressure ≤100 mmHg (13.33 kPa); 2. At least 5% of subjects shall have a systolic blood pressure ≥ 160 mmHg (21.33 kPa); 3. At least 20% of subjects should have a systolic blood pressure ≥ 140 mmHg (18.66 kPa); 4. Diastolic blood pressure should be ≤60 mmHg (8.0 kPa) in at least 5% of subjects; 5. Diastolic blood pressure should be ≥100 mmHg (13.33 kPa) in at least 5% of subjects; (f) At least 20% of subjects should have a diastolic blood pressure ≥85 mmHg (11.33 kPa); 5. Subjects must be willing and able to comply with the study procedures by signing an informed consent form after being informed about the study. consent form after understanding the contents of the study. 6. Good compliance and ability to complete the clinical trial. Exclusion Criteria: Subjects who fulfill any of the following requirements cannot be included in the study: (1) Mental illness, impaired consciousness, or other conditions that prevent them from cooperating with the study; (2) Require hemodialysis; (3) Taking anticoagulant drugs for cardiovascular diseases; (4) Pregnant and lactating women; (5) Patients with cardiac arrhythmia; (6) Patients with peripheral arterial disease and diseases that may affect arterial compliance; (7) Other conditions that are considered by the physician to be unsuitable for enrollment. \-

Locations (1)

The First Affiliated Hospital of Anhui Medical University Hospital

Hefei, Anhui, China