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ORIGINAL ARTICLE
Korean J Pediatr 2011 November;54(11) :463-469.
doi:https://doi.org/10.3345/kjp.2011.54.11.463
Validation study of the Dinamap ProCare 200 upper arm blood pressure monitor in children and adolescents
Chong Guk Lee (Lee CG)1, Hyang Mi Park (Park HM)2, Hye Jung Shin (Shin HJ)2, Jin Soo Moon (Moon JS)1, Yeong Mi Hong (Hong YM)3, Nam Soo Kim (Kim NS)4, Il Soo Ha (Ha IS)5, Myeong Jin Chang (Chang MJ)6, Kyeong Won Oh (Oh KW)6
1Department of Pediatrics, Inje University Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Kroea
2Department of Pediatrics, National Medical Center, Korea
3Department of Pediatrics, Ewha Womans University Mockdong Hospital, Ewha Womans University School of Medicine, Seoul, Korea
4Department of Pediatrics, Hanyang University Seoul Hospital, Hanyang University College of Medicine, Seoul, Korea
5Department of Pediatrics, Seoul National University Childrens Hospital, Seoul National University College of Medicine, Seoul, Korea
6Department of Chronic Disease Investigation, Korea Center for Disease and Prevention, Seoul, Korea
Corresponding Author: Chong Guk Lee ,Tel: +82-31-910-7109, Fax: +82-31-910-7108, Email: chonglee@paik.ac.kr
Copyright © 2011 by The Korean Pediatric Society
ABSTRACT
Purpose : To validate the Dinamap ProCare 200 blood pressure (BP) monitor against a mercury sphygmomanometer in children 7 to 18 years old in accordance with the 2010 International Protocol of European Society of Hypertension (ESH-IP2) and the British Hypertension Society (BHS) protocol. Methods : Forty-five children were recruited for the study. A validation procedure was performed following the protocol based on the ESHIP2 and BHS protocols for children and adolescents. Each subject underwent 7 sequential BP measurements alternatively with a mercury sphygmomanometer and the test device by trained nurses. The results were analyzed according to the validation criteria of ESH-IP2. Results : The mean (SD) difference in the absolute BP values between test device and mercury sphygmomanometer readings was 1.851.65 mmHg for systolic BP (SBP) and 4.413.53 mmHg for diastolic BP (DBP). These results fulfilled the Association for the Advancement of Medical Instrumentation criterion of a meanSD below 58 mmHg for both SBP and DBP. The percentages of test device-observer mercury sphygmomanometer BP differences within 5, 10, and 15 mmHg were 96%, 100%, and 100% for SBP, and 69%, 92%, and 100% for DBP, respectively, in the part 1 analysis; both SBP and DBP passed the part 1 criteria. In the part 2 analysis, SBP passed the criteria but DBP failed. Conclusion : Although the Dinamap ProCare 200 BP monitor failed an adapted ESH-IP2, SBP passed. When comparing BP readings measured by oscillometers and mercury sphygmomanometers, one has to consider the differences between them, particularly in DBP, because DBP can be underestimated.
Keywords: Blood pressure | Oscillometric device | Dinamap | Validation studies | International protocol
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