Status:
NOT_YET_RECRUITING
Clinical Trial on the Accuracy of Blood Pressure Measurement by YE990 Medical Automatic Electronic Sphygmomanometer
Lead Sponsor:
The First Affiliated Hospital of Anhui Medical University
Conditions:
Blood Pressure
Eligibility:
All Genders
12+ years
Brief 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...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Subjects should meet all of the following requirements for inclusion in the study:
- Both sexes; at least 30% of the subjects are male and at least 30% of the subjects are female.
- Subject's age \> 12 years.
- Arm circumference distribution:
- 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;
- At least 10% of the subjects shall have an arm circumference within the lower one-eighth interval of the total arm circumference range.
- Blood pressure distribution:
- At least 5% of subjects shall have a systolic blood pressure ≤100 mmHg (13.33 kPa);
- At least 5% of subjects shall have a systolic blood pressure ≥ 160 mmHg (21.33 kPa);
- At least 20% of subjects should have a systolic blood pressure ≥ 140 mmHg (18.66 kPa);
- Diastolic blood pressure should be ≤60 mmHg (8.0 kPa) in at least 5% of subjects;
- 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);
- 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.
- Good compliance and ability to complete the clinical trial.
Exclusion
- 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.
- \-
Key Trial Info
Start Date :
August 20 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 30 2025
Estimated Enrollment :
85 Patients enrolled
Trial Details
Trial ID
NCT06565702
Start Date
August 20 2024
End Date
December 30 2025
Last Update
August 22 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
The First Affiliated Hospital of Anhui Medical University Hospital
Hefei, Anhui, China, 230000