ABSTRACT
BACKGROUND: To validate Omron HEM 907 XL blood pressure monitor (test device) against auscultatory mercury sphygmomanometer in children aged 7-8 years old in accordance with International Protocol of European Society of Hypertension revised in 2010 (ESH-IP2) and British Hypertension Society (BHS) protocol. METHODS: Seventy-five children and adolescents were recruited for the study. A validation procedure was performed following the protocol which was prepared on the basis of ESH-IP2 and BHS protocol for children and adolescents. Each underwent 7 sequential BP measurements alternatively with a mercury sphygmomanometer and the test device. The results were analyzed according to the validation criteria of ESH-IP2. RESULTS: The mean (blood pressure [BP], +/- standard deviation [SD]) difference of absolute value between the test device and mercury sphygmomanometer readings in all the 75 subjects was 3.26 +/- 3.08 mm Hg for systolic BP and 4.11 +/- 3.50 mm Hg for diastolic BP. These results fulfilled AAMI criterion of mean +/- SD below 5 +/- 8 mm Hg for both systolic and diastolic BP. The proportion of test device-observer mercury sphygmomanometer BP differences within 5, 10 and 15 mm Hg were 81%, 96%, 99% for SBP and 72%, 93%, 99% for diastolic blood pressure (DBP), respectively, in the part 1 analysis, so both systolic blood pressure (SBP) and DBP passed the part 1 criteria. As for the part 2 analysis, SBP passed the criteria, bur DBP failed. CONCLUSIONS: Omron HEM 907 XL BP monitor failed an adapted ESH-IP2, though SBP passed. When comparing the BP readings by oscillometers with mercury sphygmomanometer, the differences between them, particularly in diastolic BP, should be taken into account, because DBP can be underestimated.