Beime Beate, Deutsch Cornelia, Krüger Ralf, Wolf Andreas, Müller Peter, Hammel Gertrud, Bramlage Peter
Institute for Pharmacology and Preventive Medicine, Bahnhofstrasse 20, 49661, Cloppenburg, Germany.
Müller & Sebastiani GmbH, Ottobrunn, Germany.
Eur J Pediatr. 2017 May;176(5):573-580. doi: 10.1007/s00431-017-2874-3. Epub 2017 Feb 24.
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.
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.
本研究的目的是根据欧洲高血压学会国际协议（ESH-IP修订版2010），验证用于3至12岁儿童的动态血压监测（ABPM）定制筛查设备。纳入了33名儿童，并根据ESH-IP进行收缩压和舒张压测量。根据德国儿童和青少年健康访谈与检查调查（KIGGS）的数据，对该协议进行了针对儿童的修改。该定制筛查设备符合ESH-IP的所有要求。测试设备与参考设备之间收缩压（SBP）的平均差值为-1.4±3.0 mmHg，舒张压（DBP）的平均差值为-0.7±3.2 mmHg。对于SBP和DBP，所有99次测量值在测试设备与参考设备之间的绝对差值10 mmHg范围内。至于协议的第2部分，对于所有受试者的DBP，三次测量中有两次在设备与标准值之间的5 mmHg范围内，而对于33名受试者中的32名的SBP，三次测量中有两次在该范围内。
该定制筛查设备符合针对3至约12岁儿童修改后的2010年ESH-IP审查的所有标准，可推荐用于儿童的ABPM。已知信息：•血压测量设备的验证对于为患者提供准确的血压测量设备至关重要。•大多数设备尚未在儿童中进行验证。新发现：•在本次验证之前，根据2013年德国儿童和青少年健康访谈与检查调查（KIGGS）对2010年ESH-IP审查的研究方案进行了针对儿童的调整。•该定制筛查测试设备符合针对儿童修改后的2010年ESH-IP修订版的所有标准，可推荐用于3至约12岁儿童的ABPM。
