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KMID : 1130320110540110463
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Korean Journal of Pediatrics
2011 Volume.54 No. 11 p.463 ~ p.469
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Validation study of the Dinamap ProCare 200 upper arm blood pressure monitor in children and adolescents
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Lee Chong-Guk
Park Hyang-Mi
Shin Hye-Jung
Moon Jin-Soo
Hong Yeong-Mi
Kim Nam-Soo
Ha Il-Soo
Chang Myeong-Jin
Oh Kyeong-Won
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Abstract
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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 1.85±1.65 mmHg for systolic BP (SBP) and 4.41±3.53 mmHg for diastolic BP (DBP). These results fulfilled the Association for the Advancement of Medical Instrumentation criterion of a mean±SD below 5±8 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.
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KEYWORD
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Blood pressure, Oscillometric device, Dinamap, Validation studies, International protocol
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