Validation of a wrist‐type home nocturnal blood pressure monitor in the sitting and supine position according to the ANSI/AAMI/ISO81060‐2:2013 guidelines: Omron HEM‐9601T

Abstract

This study aimed to validate the accuracy of the Omron HEM‐9601T, an automatic wrist‐type device for self‐blood pressure (BP) measurement with a timer function for automatic measurement of nocturnal BP, in the sitting position according to the American National Standards Institute/Association for the Advancement of Medical Instrumentation/International Organization for Standardization (ANSI/AAMI/ISO) 81060‐2:2013 guidelines, and to assess its performance in the supine position by applying the same protocol as conducted in the sitting position. The mean differences between the reference BPs and HEM‐9601T readings were 1.2 ± 6.9/1.1 ± 5.5 mmHg, 2.2 ± 6.5/1.8 ± 5.7 mmHg, 0.1 ± 6.6/1.5 ± 6.2 mmHg, and −0.8 ± 7.2/0.5 ± 6.4 mmHg for systolic BP/diastolic BP for criterion 1 in the sitting position, supine with sideways palm position, supine with upward palm position, and supine with downward palm position, respectively. In addition, the mean differences and their standard deviations for systolic BP and diastolic BP calculated according to criterion 2 in the ANSI/AAMI/ISO 81060‐2:2013 guidelines were acceptable in all four positions. In conclusion, the Omron HEM‐9601T fulfilled the validation criteria of the ANSI/AAMI/ISO81060‐2:2013 guidelines when used in the sitting position with the wrist at heart level, and its accuracy in the supine position was acceptable and roughly equivalent to that in the sitting position. The wrist‐type home BP monitor could be a more suitable tool for repeated nocturnal BP measurements at home than upper‐arm devices, and could improve the reliability of diagnosis and management of nocturnal hypertension.

Clinical significance of nocturnal home blood pressure monitoring and nocturnal hypertension in Asia

“…Since the arm‐cuff height of an HBPM device differs between the supine position and the lateral position when measuring nocturnal BP, the nocturnal BP levels might be measured in different positions. In addition, during the supine position of sleep, nocturnal BP levels vary depending on the position of the arm cuff of the upper‐arm device or wrist‐type BP device and the position of the palm when using a wrist‐type BP device 21,22 …”

The Role of Nocturnal Blood Pressure and Sleep Quality in Hypertension Management

“…NightView has been clinically validated in sitting and in supine position (with palm placed sideways, upwards and downwards), according to the ANSI/AAMI/ISO81060-2:201 protocol and has passed all criteria. 68,69 A comparison with ABPM in 85 subjects found similar results in office and out of office. 68,69 This improved possibility to detect masked nocturnal hypertension will allow optimisation of BP-lowering medication, with the ultimate goal of optimising the achievement of BP target values and reduce CV events.…”

“…[ 68 , 69 ] A comparison with ABPM in 85 subjects found similar results in office and out of office. [ 68 , 69 ] This improved possibility to detect masked nocturnal hypertension will allow optimisation of BP-lowering medication, with the ultimate goal of optimising the achievement of BP target values and reduce CV events.…”

Simultaneous self‐monitoring comparison of a supine algorithm‐equipped wrist nocturnal home blood pressure monitoring device with an upper arm device

“…In the validation study of the wrist home BP monitoring device, the HEM‐9601T, the mean difference in SBP measured by a mercury sphygmomanometer and the HEM‐9601T was 0.1 mmHg 12 . This discrepancy may be caused by the different references of the BP measurements.…”