ObjectiveThe aim of the present study was to validate the custo screen 400 ambulatory blood pressure-monitoring (ABPM) device according to the 2010 International Protocol revision of the European Society of Hypertension (ESH-IP). The device can be used for ABPM for up to 72 hours.Materials and methodsSystolic and diastolic blood pressure (SBP and DBP, respectively) were sequentially measured in 33 adult subjects (13 males and 20 females) and compared with a standard mercury sphygmomanometer (two observers). A total of 99 comparison pairs were obtained.ResultsThe custo screen 400 met the requirements of parts 1 and 2 of the ESH-IP revision 2010. The mean difference between the device and reference sphygmomanometer readings was −0.5±4.5 mmHg for SBP and −0.1±3.3 mmHg for DBP. All but one measurement were within the absolute difference of 10 mmHg between the device and the observers for SBP and DBP. The number of absolute differences between the device and the observers within a range of 5 mmHg was 84 of 99 readings for SBP, and 93 of 99 readings for DBP.ConclusionThe custo screen 400 ABPM device met the requirements of the 2010 ESH-IP revision, and hence can be recommended for ABPM in adults. To our knowledge, the custo screen 400 is the first device to pass the revised ESH-IP 2010.
The custo screen pediatric met all criteria of the ESH-IP review 2010, modified for children from 3 to about 12 years, and can be recommended for ABPM in children. What is Known: • Validation of blood pressure measuring devices is essential to provide patients with an accurate blood pressure measuring device. • The majority of devices has not been validated in children. What is New: • Prior to the present validation, study protocol adjustments of ESH-IP review 2010 for children were defined according to German Health Interview and Examination Survey for Children and Adolescents 2013 (KIGGS). • The custo screen pediatric test device met all criteria of ESH-IP revision 2010, modified for children, and can be recommended for ABPM in children aged 3 to about 12 years.
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