Korean J Pediatr.
2011 Nov;54(11):463-469. 10.3345/kjp.2011.54.11.463.
Validation study of the Dinamap ProCare 200 upper arm blood pressure monitor in children and adolescents
- Affiliations
-
- 1Department of Pediatrics, Inje University Ilsan Paik Hospital, Inje University College of Medicine, Goyang, Korea. chonglee@paik.ac.kr
- 2Department of Pediatrics, National Medical Center, Seoul, 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 Children's Hospital, Seoul National University College of Medicine, Seoul, Korea.
- 6Department of Chronic Disease Investigation, Korea Center for Disease and Prevention, Seoul, Korea.
- KMID: 1506497
- DOI: http://doi.org/10.3345/kjp.2011.54.11.463
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 ESH-IP2 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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