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

Not yet recruiting

• Conditions: Blood Pressure

• Registration Number: NCT06565702
• Lead Sponsor: The First Affiliated Hospital of Anhui Medical University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-7-15
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To evaluate the accuracy of the arm-type electronic blood pressure monitor (Model: YE660D) in measuring systolic blood pressure, diastolic blood pressure and pulse rate in adults aged 12 years and above.

Secondary Outcome Measures

Name	Time	Method
Collect and document the occurrence of adverse events and device defects in subjects during use