Blood pressure
Conditions
Interventions
Test Medical Devices (Blood Pressure Monitors to be Measured):The blood pressure of the subjects was measured using the trial electronic sphygmomanometer YE680B
Control medical device (reference sphygmomanometer):Subject's blood pressure was measured using a conventional mercury sphygmomanometer
Sponsors
The First Affiliated Hospital of Anhui Medical University
Eligibility
Sex/Gender
All
Age
3 Years to 85 Years
Inclusion criteria
Inclusion criteria: 1. Age Requirement Adults and children aged 3 years and above are not suitable for newborns. The total enrollment is at least 100, of which at least 35 children aged 3-12 years are required; In this trial, children were defined as people aged 3 years (inclusive) to 12 years (inclusive); Adults and adolescents: 12 years old and above; 2. Gender requirements No less than 30% of subjects are required to be male and not less than 30% of subjects are female; 3. Blood pressure distribution requirements > = 5% of participants had systolic blood pressure (control reading) = 5% of participants had systolic blood pressure (control readings) > = 160 mmHg; > = 20% of participants had systolic blood pressure (control reading) > = 140 mmHg; Diastolic blood pressure (control reading) in > = 5% of participants = diastolic blood pressure (read by the control group) in = 5% of participants > = 100 mmHg; > = diastolic blood pressure (read by the control group) in 20% of participants > = 85 mmHg; Other blood pressures are distributed between these limits (blood pressure values here are calculated based on values read from mercury sphygmomanometers); 4. Arm circumference requirements (cuff range 17cm-52cm) At least 20% of subjects had arm circumference in any 1/4 segment of the overall cuff size; At least 10% of participants had arm circumference within 1/8 of the overall cuff size; At least 10% of subjects had arm circumference within the lower 1/8 of the overall cuff size; 5. Voluntarily participate in this clinical trial, and sign the informed consent form or the guardian signs the informed consent form; 6. Good compliance and ability to cooperate with the completion of the entire clinical trial.
Exclusion criteria
Exclusion criteria: 1. Those who have mental illness or are unable to cooperate quietly (talking/moving during the measurement); or subjects who may have difficulty in measuring blood pressure due to skin reasons, limb reasons, etc.; 2. Those who are receiving dialysis treatment or taking anticoagulants, antiplatelet agents, steroids and other drugs; 3. Those who are not covered by the size of the arm circumference cuff; or subjects who have difficulty measuring their blood pressure in a seated position; 4. Patients with arrhythmias.; 5. Patients with peripheral arterial disease and diseases that may affect arterial compliance; 6. Those who smoke, drink coffee or have not emptied their bladder within 30 minutes before the measurement; 7. Women who are pregnant at the time of participation in the study; 8. Other conditions that the doctor considers not suitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Measurement error mean vs. standard deviation; | — |
Secondary
| Measure | Time frame |
|---|---|
| Measure the agreement between the measured and reference blood pressure values (Bland-Altman analysis);Measure the relationship between arm circumference and measurement error;Relative error of pulse rate; | — |
Countries
China
Contacts
Public ContactSong Bing
The First Affiliated Hospital of Anhui Medical University
Outcome results
None listed