Evaluation of the performance of a wrist blood pressure measuring device with a position sensor compared to ambulatory 24-hour blood pressure measurements.

This randomized, single-center, open, within-subject study evaluated the performance of the Braun PrecisionSensor 2000 blood pressure (BP) measurement wrist device (BP 2000, Braun GmbH, Germany) with and without the position sensor, and compared the results with data obtained from 24-h ambulatory BP measurement (ABPM, A&D TM 2430). In a crossover design, 43 subjects performed BP measurements with the BP 2000 during two 7-day periods, one with the position sensor and the other without the position sensor. The correlation coefficients between all wrist self-measurements and ABPM were 0.73 for systolic and 0.65 for diastolic BP (with position sensor) compared to 0.70 and 0.60 for readings without position sensor, respectively. The categorization of subjects as normotensive or hypertensive, using the wrist device in subjects without specific training, achieved a correct classification of 84% (with position sensor) and 81% (without position sensor) in comparison to ABPM. When the measurements were performed in the clinic by an experienced observer, the correct classification was 79% in comparison to ABPM. The crossover study design did not show any significant variation between the two devices with regard to reproducibility of readings at the wrist. In conclusion, self-BP measurements with BP 2000, by untrained subjects, produced results consistent with those found recently with self-BP measurements with upper arm devices, when both data sets are compared with ABPM. The rates of false classification of normotension/hypertension with the wrist device were small and at least as reliable as office measurements.

RCT Entities:   Population Interventions Outcomes