Overall accuracy of the BpTRUâ„¢ -: an automated electronic blood pressure device
Overall accuracy of the BpTRUâ„¢ -: an automated electronic blood pressure device
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DOI：
10.1097/00126097-200402000-00009
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发表时间：
2004-02-01
影响因子：
1.3
通讯作者：
Wright, JM
中科院分区：
文献类型：
--
作者：
Mattu, GS;Heran, BS;Wright, JM
本报告的目的是将早期成人研究的数据与儿科研究的数据相结合，以确定BpTRU(TM) （BPM-100模型）与公认的标准听诊汞血压计相比的总体准确性。设计将成人和儿科研究中记录的个体血压点直接与从两项独立研究中收集和存储的数据中相应的观察者参考测量值进行比较。在成人研究中有255组读数，在儿科研究中有162组读数，在这项研究中，这些读数加在一起产生了417对血压读数。方法计算417次测量的总体观察者标准参考平均值，并计算其与总体平均BPM-100的差值，并计算SD和极差。在5、10和15毫米汞柱范围内的测量值以百分比表示。结果本研究共纳入121名受试者（成人研究85名，儿科研究36名）。从这些数据中，记录了417对测量结果。BpTRU（TM）与参考标准收缩压（BP）的平均差值为0.47±5.40 mmHg，其中89.2%的测量值在5 mmHg范围内，96.4%在10 mmHg范围内，99.3%在15 mmHg范围内。BpTRU（TM）与参考舒张压的平均差值为-2.12±5.93 mmHg，其中81.1%在5 mmHg范围内，92.1%在10 mmHg范围内，97.6%在15 mmHg范围内。结论BpTRU（TM）已被证明是一种准确的无创血压监测设备，适用于大范围年龄（3-83岁）的普通人群。该联合研究符合医疗器械进步协会的所有要求，并在BHS协议中达到了W级。(C) 2004利平科特·威廉姆斯·威尔金斯。
Background The objective of this report is to combine the data from an earlier adult study with the data from a paediatric study in order to determine the overall accuracy of the BpTRU(TM) (BPM-100 model) as compared to the recognized standard, auscultatory mercury sphygmomanometer.Design The individual blood pressure points recorded for both adult and paediatric studies were compared directly to its corresponding observer reference measurements from data collected and stored from the two separate studies. There were 255 sets of readings in the adult study and 162 sets from the paediatric study, which were combined to make 417 pairs of blood pressure readings for this study.Methods The overall observer standard reference mean for the 417 measurements was calculated and the difference between this and the overall mean BPM-100 was calculated with SD and ranges. Measurements within 5, 10 and 15 mmHg agreement were expressed as percentages.Results A total of 121 subjects were included for this study (85 from the adult study and 36 from the paediatric study). From these, 417 paired measurements were recorded. The mean difference between the BpTRU(TM) and the reference standard systolic blood pressure (BP) was 0.47 +/- 5.40 mmHg with 89.2% measurements within 5 mmHg, 96.4% within 10 mmHg and 99.3% within 15 mmHg. The mean difference between the BpTRU(TM) and reference diastolic BP was -2.12 +/- 5.93 mmHg with 81.1% within 5 mmHg, 92.1% within 10 mmHg and 97.6% within 15 mmHg.Conclusion The BpTRU(TM) has been shown to be an accurate non-invasive blood pressure monitoring device in the general population over a wide range of ages (3-83 years). This combined study meets all requirements of the Association of Advancement of Medical Instrumentation and achieved a grade W in the BHS protocol. (C) 2004 Lippincott Williams Wilkins.