Validation of the Omron 637IT wrist blood pressure measuring device with a position sensor according to the International Protocol in adults and obese adults

Abstract

Wrist blood pressure devices are becoming popular for the self-measurement of blood pressure. Despite widespread use of these devices, there is limited published evidence for their accuracy and reliability. In this study, we assessed the accuracy of the Omron 637IT wrist blood pressure device against the mercury sphygmomanometer in adults and obese adults according to the International Protocol criteria. A hundred and thirty-one participants were studied and classified on the basis of the International Protocol range. Blood pressure measurements at the wrist using the Omron 637IT were compared with the results obtained by two trained observers using a mercury sphygmomanometer. Nine sequential blood pressure measurements were taken. Initially, 33 participants with random arm circumferences were selected for the first validation study. Then, the device was evaluated in adults with arm circumferences equal to or higher than 34 cm. During each validation study, 99 measurements were obtained for comparison from the 33 participants. The first phase was performed on 15 participants, and, if the device passed this phase, 18 more participants were selected. Mean discrepancies and standard deviations of the sphygmomanometer device were 0.5+/-6.2 mmHg for systolic blood pressure and 0.1+/-3.7 mmHg for diastolic blood pressure in the adult group. The device passed phases 1 and 2 in 33 participants. Mean discrepancies and standard deviations of the sphygmomanometer device were 1.8+/-6.6 mmHg for systolic blood pressure and 1.6+/-4.7 mmHg for diastolic blood pressure in the obese adult group. The device passed phases 1 and 2 in 33 participants in this group. The Omron 637IT passed according to the International Protocol criteria and can be recommended for use in adults and obese adults.