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.