Accuracy validation of the Microlife 3AS1-2 blood pressure device in a pregnant population with low blood pressure
Accuracy validation of the Microlife 3AS1-2 blood pressure device in a pregnant population with low blood pressure
复制标题
DOI：
10.1097/mbp.0000000000000134
复制
发表时间：
2015-10-01
影响因子：
1.3
通讯作者：
Shennan, Andrew H.
中科院分区：
文献类型：
--
作者：
Nathan, Hannah L.;de Greeff, Annemarie;Shennan, Andrew H.
目的评估 Microlife 3AS1-2 血压（BP）设备对低血压孕妇的准确性，以探讨低收入和中等收入国家低血压检测的适用性。方法根据英国高血压协会（BHS）协议方法，对手持式上臂半自动血压设备 Microlife 3AS1-2 进行前瞻性观察研究。从产前病房和诊所招募了 30 名临床收缩压低于 100mmHg 和/或舒张压低于 60mmHg 的（稳定）孕妇，并由南非一家区级医院的三名训练有素的观察员测量了她们的血压。根据 BHS 分级标准（A/B=通过）以及 ANSI/AAMI/ISO 标准的均值差和 SD (58mmHg) 评估准确性。结果根据 BHS 分级标准，设备达到了 A/A 级。观察者和测试设备之间的收缩压和舒张压平均差 +/- SD 分别为 0.5 +/- 6.2 和 1.3 +/- 5.4mmHg，满足 ANSI/AAMI/ISO 协议要求的标准。所有观察者差异均在 4mmHg 以内。结论根据 BHS 协议，Microlife 3AS1-2 血压装置对低血压孕妇是准确的。该装置之前已在怀孕和先兆子痫中得到验证，并且也符合世界卫生组织在资源匮乏环境中使用的标准。尽管不稳定的女性没有被纳入本次验证（出于安全和务实的原因），但该设备有可能改善产科出血或脓毒症继发性休克的检测，以及用于先兆子痫，特别是在低收入和中等收入国家。
ObjectiveTo assess the accuracy of the Microlife 3AS1-2 blood pressure (BP) device in pregnant women with low BP to investigate suitability for hypotensive detection in low-income and middle-income countries.MethodsA prospective observational study was carried out evaluating the Microlife 3AS1-2, a hand-held, upper-arm, semiautomated BP device, according to British Hypertension Society (BHS) protocol methods. Thirty (stable) pregnant women with a clinical systolic BP less than 100mmHg and/or diastolic BP less than 60mmHg were recruited from antenatal wards and clinics and their BP was measured by three trained observers at a district-level hospital in South Africa. Accuracy was assessed according to the BHS grading criteria (A/B=pass) and the ANSI/AAMI/ISO standard for mean difference and SD (58mmHg).ResultsThe device achieved an A/A grade according to the BHS grading criteria. The mean difference +/- SD between the observer and the test device was 0.5 +/- 6.2 and 1.3 +/- 5.4mmHg for systolic and diastolic BP, respectively, fulfilling the standard required by the ANSI/AAMI/ISO protocol. All observer differences were within 4mmHg.ConclusionAccording to the BHS protocol, the Microlife 3AS1-2 BP device is accurate in pregnant women with low BP. The device has been validated previously in pregnancy and pre-eclampsia and also fulfils the criteria of the WHO for use in a low-resource setting. Although unstable women were not included in this validation (for safety and pragmatic reasons), this device could potentially improve the detection of shock secondary to obstetric haemorrhage or sepsis, as well as being used in pre-eclampsia, particularly in low-income and middle-income countries.