Anwar YA, Tendler BE, McCabe EJ, Mansoor GA, White WB
Section of Hypertension and Vascular Diseases, University of Connecticut School of Medicine, Farmington, Connecticut, USA.
Blood Press Monit. 1997 Apr;2(2):105-110.
Automatic noninvasive blood pressure measurement devices should be clinically validated prior to marketing using standard criteria such as those published by the Association for the Advancement of Medical Instrumentation and the British Hypertension Society. OBJECTIVE: To assess a new bedside oscillometric device (Accutorr Plus, Datascope Inc., Montvale, New Jersey, USA). METHODS: We compared measurements obtained using the device with mercury column measurements for 90 subjects (448 measurements). In addition to calculation of the limits of agreement for the device versus observers, we determined the impact of age, the blood pressure level, the body mass, and the arm size on the levels of agreement. RESULTS: There was a good agreement between observers, with a mean difference of 0.38 +/- 4.47 mmHg for the systolic and 0.0 +/- 3.7 mmHg for the diastolic blood pressure. The observer-device agreement was -0.04 +/- 7.93 mmHg for the systolic and 0.35 +/- 5.75 mmHg for the diastolic blood pressure. Regression analyses showed that, as the systolic blood pressure and age increased, the level of disagreement for the systolic blood pressure also increased ( P < 0.001 for both). CONCLUSIONS: The Accutorr Plus satisfied the criteria of the Association for the Advancement of Medical Instrumentation for a general adult population with large ranges in age, blood pressure, body mass and arm circumference. Not unlike many oscillometric devices, for systolic blood pressures > 190 mmHg, the device error increased.
自动无创血压测量设备在上市前应根据诸如美国医疗仪器促进协会和英国高血压学会发布的标准进行临床验证。目的：评估一种新型床旁示波法设备（Accutorr Plus，Datascope公司，美国新泽西州蒙特瓦尔）。方法：我们将该设备的测量结果与90名受试者（448次测量）的汞柱测量结果进行了比较。除了计算该设备与观察者之间的一致性界限外，我们还确定了年龄、血压水平、体重和手臂尺寸对一致性水平的影响。结果：观察者之间一致性良好，收缩压平均差异为0.38±4.47 mmHg，舒张压平均差异为0.0±3.7 mmHg。观察者与设备之间的一致性为收缩压-0.04±7.93 mmHg，舒张压0.35±5.75 mmHg。回归分析表明，随着收缩压和年龄的增加，收缩压的不一致程度也增加（两者P均<0.001）。结论：Accutorr Plus满足美国医疗仪器促进协会针对年龄、血压、体重和臂围范围较大的一般成年人群的标准。与许多示波法设备一样，对于收缩压>190 mmHg的情况，该设备误差会增加。
