Validation of the custo screen pediatric blood pressure monitor according to the European Society of Hypertension International Protocol revision 2010
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.
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.
KeywordsValidation Blood pressure measuring device Children ESH Custo screen pediatric
Ambulatory blood pressure monitoring
Diastolic blood pressure
European Society of Hypertension
German Health Interview and Examination Survey for Children and Adolescents
Systolic blood pressure
Custo Med GmbH, Ottobrunn, Germany, provided funding to IPPMed for this validation study.
AW, PM, BB, and CD designed the study and developed the study protocol; RK, PB, and GH acquired, analyzed, and/or interpreted the data. BB, CD, and PB drafted the manuscript which was revised critically for important intellectual content by the other authors. All approved the final version to be published and agree to be held accountable for all aspects of the work ensuring that questions related to the accuracy or integrity of any part of the work are appropriately investigated and resolved.
Compliance with ethical standards
All procedures performed were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards. No ethical approval was required prior to the commencement of the study as to local regulations. Informed consent was obtained from all individual participants included in the study.
Conflict of interest
Andreas Wolf (AW) is an employee and Peter Müller (PM) shareholder of Müller & Sebastiani and custo med GmbH, Germany. Beate Beime (BB), Cornelia Deutsch (CD), Ralf Krüger (RK), and Peter Bramlage (PB) disclose to have performed validation studies for a number of companies producing blood pressure monitors for which the institute was paid; this includes custo med and the current study. Gertrud Hammel (GH) was paid for performing the statistical analysis by IPPMed.
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