根据国际协议对安灯KD - 391半自动血压监测仪在成人中的验证。

Validation of the Andon KD-391 semiautomated blood pressure monitor in adults according to the International Protocol.

作者信息

Wan Yi, Pan Feng, Liu Ya, Liang Ying, Yang Zhe, Zhao Huadong, Xu Yongyong

机构信息

Institute for Health Informatics, Fourth Military Medical University, Xi'an, China.

出版信息

Blood Press Monit. 2009 Aug;14(4):181-4. doi: 10.1097/MBP.0b013e32832db4c2.

DOI:10.1097/MBP.0b013e32832db4c2

PMID:19512888

Abstract

OBJECTIVE

Accurate blood pressure measurement is important for both the patients and the health service in appropriate treatment and estimation of clinical risk. Few automated devices have been shown to be accurate when compared with mercury sphygmomanometer. This study presents the validation results of the Andon KD-391 semiautomated blood pressure monitor according to the International Protocol of the European Society of Hypertension (ESH) in an adult population.

METHODS

Sequential measurements of systolic and diastolic blood pressures were obtained in 33 participants who fulfilled the requirements of the International Protocol using the mercury sphygmomanometer (two observers) and the test device (one supervisor). According to the ESH validation protocol, 99 couples of test device and reference blood pressure measurements were obtained during the two phases of the study (three pairs for each of the 33 participants).

RESULTS

In phase 1, the Andon KD-391 device produced 29, 38 and 44 measurements for systolic blood pressure and 28, 39 and 43 for diastolic blood pressure falling within the zones 5, 10 and 15 mmHg, respectively. The test device also passed phase 2 of the validation study with a mean (+/-SD) device-observer difference of -0.17+/-7.07 mmHg for systolic and -1.01+/-5.95 mmHg for diastolic blood pressure.

CONCLUSION

According to the results of the validation study on the basis of the ESH International Protocol, the Andon KD-391 can be recommended for clinical use in an adult population.

摘要

目的

准确测量血压对于患者和医疗服务机构进行适当治疗及评估临床风险均至关重要。与汞柱式血压计相比，很少有自动设备被证明是准确的。本研究根据欧洲高血压学会（ESH）的国际协议，展示了安多KD - 391半自动血压监测仪在成年人群中的验证结果。

方法

对33名符合国际协议要求的参与者，使用汞柱式血压计（两名观察者）和测试设备（一名监督员）依次测量收缩压和舒张压。根据ESH验证协议，在研究的两个阶段共获得99组测试设备与参考血压测量值（33名参与者每人3组）。

结果

在第一阶段，安多KD - 391设备测量的收缩压落在5、10和15 mmHg范围内的次数分别为29、38和44次，舒张压落在相应范围内的次数分别为28、39和43次。该测试设备也通过了验证研究的第二阶段，收缩压的设备 - 观察者平均差值为 -0.17±7.07 mmHg，舒张压为 -1.01±5.95 mmHg。