A new approach to reproducibility assessment: clinical evaluation of SpaceLabs Medical oscillometric blood pressure monitor.
The SpaceLabs Medical oscillometric blood pressure monitor was evaluated in both neonatal and adult populations according to the 1992 AAMI SP-10 standard for electronic or automated sphygmomanometers. For the neonatal study, the umbilical artery pressure was used as a reference. Fifteen newborn ICU patients were enrolled in the study, yielding a total of 150 pairs of comparison readings. For the adult study, the first and fifth phases of the Korotkoff sounds were used as a reference. One hundred twelve adults were enrolled in the study, yielding a total of 336 pairs of comparison readings. Accuracy was analyzed by the AAMI SP-10 standard. For systolic and diastolic pressures, respectively, the mean differences +/- standard deviations of oscillometric accuracy were 0.1 +/- 4.3 and 2.7 +/- 4.8 mmHg for the neonatal study and -0.6 +/- 5.9 and 0.9 +/- 6.4 mmHg for the adult study, which are within the AAMI SP-10 accuracy standard. Reproducibility was analyzed by a new approach developed from the sequential technique of the 1990 British Hypertension Society protocol. For systolic and diastolic pressures, respectively, the mean differences +/- standard deviations of the oscillometric reproducibility were estimated to be -0.1 +/- 3.3 and 0.1 +/- 3.4 mmHg for the neonatal study and -0.3 +/- 3.2 and 0.1 +/- 3.5 mmHg for the adult study.
Space-Labs Medical, Redmond, WA 98073-9713, USA.
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Sun
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Tien
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Jones
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Ward
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001795:Blood Pressure Determination / Q000379:methods / Q000592:standards*; D015924:Blood Pressure Monitors / Q000592:standards; D001916:Brachial Artery / Q000502:physiology; D005069:Evaluation Studies as Topic; D005260:Female; D006326:Heart Auscultation; D006801:Humans; D007231:Infant, Newborn; D008297:Male; D008875:Middle Aged; D015588:Observer Variation; D015203:Reproducibility of Results; D014469:Umbilical Arteries / Q000502:physiology