Objective: To investigate pulse oximetry in neonates who require arterial access as represented by the clinical data recorded to manage their care.
Study design: Analysis of simultaneous SpO(2) and SaO(2) from: 7-year historical NICU data (N=31905); 4-month prospective NICU data (N=566); verification data using two hemoximeters (N=52); and NICU data from two collaborating centers (N=95 and 168). The bias function (SpO(2)-SaO(2)) was regressed against the measured "gold" standard, SaO(2).
Results: A significant negative correlation was found for each of the data sets between the bias function and SaO(2). This bias was similar for devices from several manufacturers (Datex-Ohmeda, Masimo, Nellcor, and Spacelabs). Maximum operational performance occurred with peaks between 92 and 97% SaO(2), but declined markedly above and below this narrow range. In all, 71 to 95% of patients exhibited data with significant bias(.)
Conclusion: These operational data suggest that with the methodology and devices currently in use, SpO(2) values in most all neonates who require arterial lines inaccurately correlate with measured arterial saturation.