Validation of Polar ElixirTM Pulse Oximeter against Arterial Blood Gases during Stepwise Steady State Inspired Hypoxia
Monica K. Russell, John F. Horton, Christian A. Clermont, Jennifer M. Demarty, Leo C. Transfiguracion, Breann R. Worobets, Mark E. Pineda, Nuutti Santaniemi, Pro Stergiou, Michael J. Asmussen, Trevor A. DayABSTRACT
Purpose
The purpose of this study was to evaluate the accuracy of peripheral oxygen saturation (SpO2) measurements from Polar ElixirTM pulse oximetry technology compared to arterial oxygen saturation (SaO2) measurements during acute stepwise steady state inspired hypoxia at rest. A post hoc objective was to determine if SpO2 measurements could be improved by recalibrating the Polar ElixirTM algorithm with SaO2 values from a random subset of participants.
Methods
The International Organization for Standardization (ISO) protocol (ISO 80601-2-61:2017) for evaluating the SpO2 accuracy of pulse oximeter equipment was followed whereby five plateaus of SaO2 between 70-100% were achieved using stepwise reductions in inspired O2 during supine rest. Blood samples drawn through a radial arterial catheter from 25 participants were first used to compare SaO2 to SpO2 measurements from Polar ElixirTM. Then the Polar ElixirTM algorithm was recalibrated using SaO2 data from 13 random participants and SpO2 estimates were recalculated for the other 12 participants. For SaO2 values between 70-100%, root mean square error (RMSE), intraclass correlations (ICC), Pearson correlations, and Bland-Altman plots were used to assess the accuracy, agreement, and strength of relationship between SaO2 values and SpO2 values from Polar ElixirTM.
Results
The initial RMSE for Polar ElixirTM was 4.13%. After recalibrating the algorithm, the RMSE was improved to 2.67%. The ICC revealed excellent levels of agreement between SaO2 and Polar ElixirTM SpO2 values both before (ICC(3,1) = 0.837, df = 574, p < 0.001) and after (ICC(3,1) = 0.942, df = 287, p < 0.001) recalibration.
Conclusions
Relative to ISO standards, Polar ElixirTM yielded accurate SpO2 measurements during stepwise inspired hypoxia at rest when compared to SaO2 values, which were improved by recalibrating the algorithm using a subset of the SaO2 data.