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Validation Studies
Validation of three oscillometric blood pressure devices against auscultatory mercury sphygmomanometer in children.
Blood Pressure Monitoring 2006 October
AIM: To validate Welch-Allyn Vital Sign Monitor, Dinamap Procare-120 and Datascope Accutorr Plus against auscultatory mercury sphygmomanometer in children aged 5-15 years old according to the International Protocol of European Society of Hypertension adapted for validation in children.
METHOD: One hundred and thirty two children were studied (44 for each device; 67 boys, 65 girls). Each underwent seven sequential BP measurements on the right arm resting in the sitting position, alternately with the mercury sphygmomanometer read simultaneously by two independent, trained observers and the test device by a third observer.
RESULTS: For the Welch-Allyn monitor, the mean+/-SD of differences (device minus auscultatory BP) were -4.39+/-4.82 mmHg for systolic blood pressure and -4.1+/-7.07 mmHg for diastolic blood pressure. The device failed phase 2.1 for both systolic blood pressure (55, 91 and 98% were within 5, 10 and 15 mmHg, respectively) and diastolic blood pressure measurements (46, 82 and 95% were within 5, 10 and 15 mmHg, respectively). For the Dinamap device, the mean+/-SD of differences were -3.08+/-5.21 mmHg for systolic blood pressure and -4.61+/-9.35 mmHg for diastolic blood pressure. The device passed phase 2.1 for systolic blood pressure (71, 96 and 98% were within 5, 10 and 15 mmHg, respectively) but failed for diastolic blood pressure (51, 72 and 91% were within 5, 10, and 15 mmHg, respectively). For the Datascope device, mean+/-SD of differences were -0.9+/-4.33 mmHg for systolic blood pressure and -1.20+/-6.48 mmHg for diastolic blood pressure. The device passed phase 2.1 in that 84, 97 and 99% of systolic blood pressure, and 61, 89 and 97% of diastolic blood pressure readings were within 5, 10 and 15 mmHg, respectively. It also passed phase 2.2 for both systolic blood pressure and diastolic blood pressure.
CONCLUSION: We performed an independent validation of three oscillometric BP devices in children. Overall Datascope Accutorr Plus passed, whereas Welch-Allyn Vital Sign Monitor and Dinamap Procare-120 failed an adapted IP-ESH.
METHOD: One hundred and thirty two children were studied (44 for each device; 67 boys, 65 girls). Each underwent seven sequential BP measurements on the right arm resting in the sitting position, alternately with the mercury sphygmomanometer read simultaneously by two independent, trained observers and the test device by a third observer.
RESULTS: For the Welch-Allyn monitor, the mean+/-SD of differences (device minus auscultatory BP) were -4.39+/-4.82 mmHg for systolic blood pressure and -4.1+/-7.07 mmHg for diastolic blood pressure. The device failed phase 2.1 for both systolic blood pressure (55, 91 and 98% were within 5, 10 and 15 mmHg, respectively) and diastolic blood pressure measurements (46, 82 and 95% were within 5, 10 and 15 mmHg, respectively). For the Dinamap device, the mean+/-SD of differences were -3.08+/-5.21 mmHg for systolic blood pressure and -4.61+/-9.35 mmHg for diastolic blood pressure. The device passed phase 2.1 for systolic blood pressure (71, 96 and 98% were within 5, 10 and 15 mmHg, respectively) but failed for diastolic blood pressure (51, 72 and 91% were within 5, 10, and 15 mmHg, respectively). For the Datascope device, mean+/-SD of differences were -0.9+/-4.33 mmHg for systolic blood pressure and -1.20+/-6.48 mmHg for diastolic blood pressure. The device passed phase 2.1 in that 84, 97 and 99% of systolic blood pressure, and 61, 89 and 97% of diastolic blood pressure readings were within 5, 10 and 15 mmHg, respectively. It also passed phase 2.2 for both systolic blood pressure and diastolic blood pressure.
CONCLUSION: We performed an independent validation of three oscillometric BP devices in children. Overall Datascope Accutorr Plus passed, whereas Welch-Allyn Vital Sign Monitor and Dinamap Procare-120 failed an adapted IP-ESH.
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