title: Validation of the custo screen pediatric blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010.
abstract: The purpose of the study was to validate the ambulatory blood pressure monitoring (ABPM) device custo screen pediatric in children aged 3 to 12 years according to the International Protocol of the European Society of Hypertension (ESH-IP revision 2010). Thirty-three children were included and systolic and diastolic blood pressure measurements were performed according to the ESH-IP. The protocol was modified for children considering data from the German Health Interview and Examination Survey for Children and Adolescents (KIGGS). The custo screen pediatric met all the requirements of the ESH-IP. The mean difference between the test device and the reference was -1.4 ± 3.0 mmHg for systolic blood pressure (SBP) and -0.7 ± 3.2 mmHg for diastolic blood pressure (DBP). For SBP and DBP, all 99 measurements were within the absolute difference of 10 mmHg between the test device and the reference. As to part 2 of the protocol, for DBP in all subjects, two out of three measurements were within 5 mmHg between the device and the standard, whereas for SBP in 32 of 33 subjects, two out of three measurements were within this range.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Institute for Pharmacology and Preventive Medicine, Bahnhofstrasse 20, 49661, Cloppenburg, Germany. beate.beime@ippmed.de.
authors.forename: Beate
authors.initials: B
authors.lastname: Beime
authors.affiliation: Institute for Pharmacology and Preventive Medicine, Bahnhofstrasse 20, 49661, Cloppenburg, Germany.
authors.forename: Cornelia
authors.initials: C
authors.lastname: Deutsch
authors.affiliation: Institute for Pharmacology and Preventive Medicine, Bahnhofstrasse 20, 49661, Cloppenburg, Germany.
authors.forename: Ralf
authors.initials: R
authors.lastname: Krüger
authors.affiliation: Müller & Sebastiani GmbH, Ottobrunn, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Wolf
authors.affiliation: Müller & Sebastiani GmbH, Ottobrunn, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Müller
authors.affiliation: Estimate GmbH, Augsburg, Germany.
authors.forename: Gertrud
authors.initials: G
authors.lastname: Hammel
authors.affiliation: Institute for Pharmacology and Preventive Medicine, Bahnhofstrasse 20, 49661, Cloppenburg, Germany.
authors.forename: Peter
authors.initials: P
authors.lastname: Bramlage
mesh_terms: D001794:Blood Pressure; D018660:Blood Pressure Monitoring, Ambulatory / Q000295:instrumentation* / Q000592:standards; D015924:Blood Pressure Monitors / Q000592:standards*; D002648:Child; D002675:Child, Preschool; D004867:Equipment Design; D005260:Female; D006801:Humans; D008297:Male; D017410:Practice Guidelines as Topic; D012016:Reference Values; D015203:Reproducibility of Results; D012955:Societies, Medical
keywords: Blood pressure measuring device; Children; Custo screen pediatric; ESH; Validation