Operational Evaluation of Pulse Oximetry in NICU Patients with Arterial Access

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Abstract
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 SpO2 and SaO2 from: 7-year historical NICU data (N=31,905); 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 (SpO2-SaO2) was regressed against the measured "gold" standard, SaO2. RESULTS: A significant negative correlation was found for each of the data sets between the bias function and SaO2. 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% SaO2, 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, SpO2 values in most all neonates who require arterial lines inaccurately correlate with measured arterial saturation.