The prevalence of hypertension among Chinese children has increased greatly in recent years. Given blood pressure tracks from childhood into adulthood, screening for hypertension among asymptomatic children plays an important role in reducing blood pressure in childhood and cardiovascular events in adulthood. However, only a few blood pressure measuring devices used in Chinese children were validated by international protocols. Therefore, the aim of this study was to validate the accuracy of Raycome RBP-1200 upper-arm pulse wave device in children aged 3-12 years according to the Association for the Advancement of Medical Instrumentation (AAMI) /International Organization for Standardization (ISO) 81060-2:2013(E) protocol.Design and Method:
A prospective observational study was carried out in children aged 3-12 years. Blood pressure was collected using “the same arm sequential method” as described in AAMI protocol. The RBP-1200 innovatively combines a pulse wave detector at the downstream position of the pressurized cuff, which determines systolic blood pressure by detecting changes of the pulse wave and diastolic blood pressure by sensing the real-time changes in the blood flow pulse. Finally, 87 children participated in this test and 255 paired-determinations were analyzed.Results:
The difference between the RBP-1200 and gold-standard mercury sphygmomanometer device was − 0.9 ± 5.3 mmHg for systolic blood pressure and − 1.1 ± 5.0 mmHg for diastolic blood pressure, which is less than 5 ± 8 mmHg as requested by criterion 1 of AAMI protocol. The standard deviation of the averaged paired determinations per subject for systolic blood pressure and diastolic blood pressure was 4.1 mmHg and 3.9 mmHg, respectively, which is also within the requirement of criterion 2 of AAMI protocol.Conclusions:
The Raycome automated upper-arm pulse wave device RBP-1200 fulfilled the requests of AAMI protocol, which means it can measure blood pressure accurately in children aged 3-12 years.