Abstract
PURPOSE: Evaluate the SpO(2)-SaO(2) difference between Black and White volunteer subjects having a low perfusion index (Pi) compared to those having a normal Pi. METHODS: The Pi data were abstracted from electronic files collected on 7183 paired SpO(2)-SaO(2) samples (3201 Black and 3982 White) from a recently reported desaturation study of 75 subjects (39 Black and 36 White) where SaO(2) values were sequentially decreased from 100 to 70%. The Pi values from that dataset were divided into two groups (Pi ≤ 1 or Pi > 1) for analysis. A Pi value ≤ 1 was considered "low perfusion" and a Pi value > 1 was considered "normal perfusion". Statistical calculations included values of bias (mean difference of SpO(2)-SaO(2)), precision (standard deviation of the difference), and accuracy (root-mean-square error [A(RMS)]). During conditions of low perfusion (Pi ≤ 1, range [0.1 to 1]), overall bias and precision were + 0.48% ± 1.59%, while bias and precision were + 0.19 ± 1.53%, and + 0.91 ± 1.57%, for Black and White subjects, respectively. RESULTS: During normal perfusion (Pi > 1, range [1 to 12]), overall bias and precision were + 0.18% ± 1.34%, while bias and precision were -0.26 ± 1.37%, and - 0.12 ± 1.31%, for Black and White subjects, respectively. A(RMS) was 1.37% in all subjects with normal perfusion and 1.64% in all subjects with low perfusion. CONCLUSION: Masimo SET® pulse oximeters with RD SET® sensors are accurate for individuals of both Black and White races when Pi is normal, as well as during conditions when Pi is low. The A(RMS) for all conditions studied is well within FDA standards. This study was conducted in healthy volunteers during well-controlled laboratory desaturations, and results could vary under certain challenging clinical conditions.