摘要

This study validated a hybrid mercury-free device as a replacement of the mercury sphygmomanometer for professional use, and also as a standard for future validations. A validation study was performed according to the European Society of Hypertension International Protocol 2010 (ESH-IP) in 33 subjects using simultaneous blood pressure (BP) measurements. A total of six BP measurements were taken per participant simultaneously by a supervisor (S; hybrid auscultatory device Nissei DM3000) and two observers (A and B; mercury sphygmomanometers). ESH-IP analysis (99 BP readings): mean device-observer systolic/diastolic BP difference 0.2 +/- 2.0/0.1 +/- 2.0 mm Hg; systolic BP differences p5/10/15mmHg in 97/99/99 readings, respectively (diastolic 98/99/99). All 33 subjects had 2 of 3 BP differences p5mmHg and none without a difference <= 5mmHg. Further analysis (198 BP readings): mean differences S-A 0.1 +/- 2.4/0.2 +/- 2.4mmHg (systolic/diastolic), S-B 0.3 +/- 2.1/0.2 +/- 2.2, A-B 0.2 +/- 2.4/0.0 +/- 2.3; differences <= 2 mm Hg S-A in 88/84% (systolic/diastolic), S-B 87/85%, A-B 87/86% and <= 4 mm Hg S-A 95/96%, S-B 95/96%, A-B 95/98%. In conclusion, a hybrid mercury-free auscultatory BP monitor comfortably passed the ESH-IP 2010 requirements and has the same level of accuracy as the mercury sphygmomanometer. This device appears to be a reliable alternative to the mercury sphygmomanometer for professional use and also as a standard for future validations. Journal of Human Hypertension (2012) 26, 220-227; doi: 10.1038/jhh.2011.77; published online 8 September 2011

  • 出版日期2012-4