Beate Botta, Carsten Bramlage, Violetta Hachaturyan, Lena Jost, Peter Bramlage
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引用次数: 0
Abstract
Background: Accurate measurement of blood pressure (BP) is crucial for the diagnosis and ongoing management of hypertension. Only devices that have been validated using an established protocol should be used to measure BP. The aim of this study was to validate the Microlife BP3T01-1B, an automated upper-arm BP measuring device, according to the DIN EN ISO 81060-2:2018-11 (ANSI/AAMI/ISO 81060-2:2018) standard protocol.
Methods: BP measurements were performed in 85 adults and adolescents (age range: 13-86 years) using the same-arm sequential method of the DIN EN ISO 81060-2:2018-11 protocol, alternating between the test device and a reference mercury sphygmomanometer.
Results: A total of 255 valid comparisons were available for the analysis of criterion 1. The mean ± SD difference between the test device and the reference device values was -2.56 ± 7.53 mmHg for SBP and -3.10 ± 5.65 mmHg for DBP. The mean differences met the pass criterion of less than or equal to ±5 mmHg and the SD values met the pass criterion of ≤8 mmHg. All 85 participants were included in the analysis of criterion 2. The mean ± SD intraindividual difference between the test and reference devices was -2.56 ± 6.15 mmHg for SBP and -3.10 ± 4.85 mmHg for DBP. Both were within the required pass range of SD ≤6.43 mmHg for SBP and SD ≤6.20 mmHg for DBP.
Conclusion: The Microlife BP3T01-1B BP monitoring device fulfilled the criteria of the DIN EN ISO 81060-2:2018-11 (ANSI/AAMI/ISO 81060-2:2018) protocol in a general population and can be recommended for the measurement of BP in adults and adolescents.
背景：准确测量血压（BP）对高血压的诊断和持续治疗至关重要。只有已通过既定方案验证的设备才能用于测量血压。本研究的目的是根据DIN EN ISO 81060-2:2018-11 （ANSI/AAMI/ISO 81060-2:2018）标准协议验证Microlife BP3T01-1B，这是一种自动上臂血压测量装置。方法：采用DIN EN ISO 81060-2:2018-11协议的同臂顺序法对85名成人和青少年（年龄范围：13-86岁）进行血压测量，在测试装置和参考汞血压计之间交替进行。结果：标准1的分析共有255个有效对照。试验装置与参考装置值的平均±SD差为收缩压-2.56±7.53 mmHg，舒张压-3.10±5.65 mmHg。平均差值满足小于等于±5 mmHg的通过标准，SD值满足≤8 mmHg的通过标准。所有85名参与者被纳入标准2的分析。试验装置与参考装置之间的个体内平均±SD差异为收缩压-2.56±6.15 mmHg，舒张压-3.10±4.85 mmHg。两者均在收缩压SD≤6.43 mmHg和舒张压SD≤6.20 mmHg的要求通过范围内。结论：Microlife BP3T01-1B血压监测装置在普通人群中符合DIN EN ISO 81060-2:2018-11 （ANSI/AAMI/ISO 81060-2:2018）协议的标准，可推荐用于成人和青少年的血压测量。
期刊介绍：
Blood Pressure Monitoring is devoted to original research in blood pressure measurement and blood pressure variability. It includes device technology, analytical methodology of blood pressure over time and its variability, clinical trials - including, but not limited to, pharmacology - involving blood pressure monitoring, blood pressure reactivity, patient evaluation, and outcomes and effectiveness research.
This innovative journal contains papers dealing with all aspects of manual, automated, and ambulatory monitoring. Basic and clinical science papers are considered although the emphasis is on clinical medicine.
Submitted articles undergo a preliminary review by the editor. Some articles may be returned to authors without further consideration. Those being considered for publication will undergo further assessment and peer-review by the editors and those invited to do so from a reviewer pool.
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