Clinical Trial on the Accuracy of Blood Pressure Measurement by YE990 Medical Automatic Electronic Sphygmomanometer
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 85
- 试验地点
- 1
- 主要终点
- 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.
研究概览
简要总结
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.
详细描述
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 "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.
(One） criteria for admission Inclusion Criteria
Subjects should meet all of the following requirements for inclusion in the study:
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Both sexes; at least 30% of the subjects are male and at least 30% of the subjects are female.
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Subject's age > 12 years.
-
Arm circumference distribution:
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At least 20% of the subjects should have arm circumference within each quarter interval of the total arm circumference range;
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At least 10% of the subjects should have arm circumference within the upper one-eighth interval of the total arm circumference range;
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At least 10% of the subjects shall have an arm circumference within the lower one-eighth interval of the total arm circumference range.
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Blood pressure distribution:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Crossover
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
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.
时间窗: August 20, 2024 - December 30, 2025
Evaluate the relationship between the mean and standard deviation of error, the agreement between the measured and reference blood pressure values, and the relationship between arm circumference and measurement error.Reference standard: 255 sets of data from 85 subjects were calculated and compared separately for systolic and diastolic blood pressure, with a mean deviation of not more than ±5 mmHg and a standard deviation of not more than 8 mmHg.
次要结局
- Collect and document the occurrence of adverse events and device defects in subjects during use(August 20, 2024 - December 30, 2025)
研究者
Hejun Liu
Chief Physician M.D., M.S.
The First Affiliated Hospital of Anhui Medical University