A novel cuffless device for self-measurement of blood pressure: concept, performance and clinical validation

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Abstract

A pocket-size cuffless electronic device for self-measurement of blood pressure (BP) has been developed (Freescan, Maisense Inc., Zhubei, Taiwan). The device estimates BP within 10 s using three embedded electrodes and one force sensor that is applied over the radial pulse to evaluate the pulse wave. Before use, basic anthropometric characteristics are recorded on the device, and individualized initial calibration is required based on a standard BP measurement performed using an upper-arm BP monitor. The device performance in providing valid BP readings was evaluated in 313 normotensive and hypertensive adults in three study phases during which the device sensor was upgraded. A formal validation study of a prototype device against mercury sphygmomanometer was performed according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 2013 protocol. The test device succeeded in obtaining a valid BP measurement (three successful readings within up to five attempts) in 55-72% of the participants, which reached 87% with device sensor upgrade. For the validation study, 125 adults were recruited and 85 met the protocol requirements for inclusion. The mean device-observers BP difference was 3.2 ± 6.7 (s.d.) mm Hg for systolic and 2.6 ± 4.6 mm Hg for diastolic BP (criterion 1). The estimated s.d. (inter-subject variability) were 5.83 and 4.17 mm Hg respectively (criterion 2). These data suggest that this prototype cuffless BP monitor provides valid self-measurements in the vast majority of adults, and satisfies the BP measurement accuracy criteria of the ANSI/AAMI/ISO 2013 validation protocol.

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