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 ≤5/10/15 mm Hg in 97/99/99 readings, respectively (diastolic 98/99/99). All 33 subjects had 2 of 3 BP differences ≤5 mm Hg and none without a difference ≤5 mm Hg. Further analysis (198 BP readings): mean differences S-A 0.1±2.4/0.2±2.4 mm Hg (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.

暂无摘要。

Mercury sphygomanometers are being banned in many countries, but what will replace them for the routine management of clinic blood pressure is unresolved. The accuracy of the two most widely used alternatives, aneroid and oscillometric devices, is questionable. A proposed alternative is a hybrid sphygomomanometer which is based on the mercury technique, but replaces the mercury column with an electronic transducer and display. It also has the potential to eliminate terminal digit preference.