Validation of the Oscar 2 oscillometric 24-h ambulatory blood pressure monitor according to the British Hypertension Society protocol
Validation of the Oscar 2 oscillometric 24-h ambulatory blood pressure monitor according to the British Hypertension Society protocol
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DOI：
10.1097/mbp.0b013e3280acab1b
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发表时间：
2007-04-01
影响因子：
1.3
通讯作者：
Jones, Stephen C.
中科院分区：
文献类型：
--
作者：
Goodwin, James;Bilous, Mary;Jones, Stephen C.
目的血压测量仪器的准确性是最重要的，在仪器投入临床使用之前，应对其进行验证。我们根据英国高血压协会(BHS)协议对OSCAR-2示波式动态血压监测仪(尚德医疗，222型)进行了独立评估。在成功完成前三个阶段后，在静态验证阶段，由两名观察者同时对114名参与者进行血压测量，两名观察者彼此盲，不知道对方的读数和设备的读数，得到255对收缩压和舒张压数据对。读数使用同步同臂测量，每个观察者使用双头双耳听诊器和校准的水银血压计。结果在较高的压力范围内，仪器的平均值和观察者的平均值(和标准差)非常接近，观察者的平均血压和舒张压的平均值分别为0+/-7 mm Hg和-1+/-6 mm Hg。62%的标准血压与设备的收缩压差等于或小于5 mm Hg，70%的相似的舒张压等于或小于5 mm Hg，该仪器被归类为A级收缩和舒张压。结论根据英国高血压协会的方案，OSCAR 2被评为A级收缩和舒张压，可以推荐给成年人临床使用。
Objectives Accuracy of blood pressure measuring devices is of prime importance and should be validated before devices are used clinically. We carried out an independent evaluation of the Oscar 2 oscillometric ambulatory blood pressure monitor (SunTech Medical, Model 222) according to the British Hypertension Society (BHS) Protocol.Methods Validation of the Oscar 2 was carried out in accordance with Part 1 of the British Hypertension Society protocol. Having successfully completed the first three phases, in the static validation phase blood pressure measurements were made on 114 participants simultaneously by two observers blinded from each other's readings and those of the device, giving 255 data pairs for systolic and diastolic blood pressure. Readings were made using simultaneous same-arm measurement, each observer using a dual-head binaural stethoscope and a calibrated mercury sphygmomanometer. Data were recorded independently, to the nearest 2 mmHg and were checked by the supervisor who operated the device.Results The device mean and observer means (and standard deviations) were exceptionally close across a high range of pressures, with a mean difference for the better observer of 0 +/- 7 mmHg and - 1 +/- 6 mmHg for systolic and diastolic blood pressure, respectively. With 62% of all systolic blood pressure standard vs. device differences equal or less than 5 mmHg, and 70% of all similar differences for diastolic blood pressure equal to or less than 5 mmHg, the device was categorized as Grade A for systolic and diastolic blood pressure.Conclusion The Oscar 2 was graded A for both systolic and diastolic blood pressure by the British Hypertension Society protocol and can be recommended for clinical use in an adult population.