Validation of Polar Elixir™ Pulse Oximeter against Arterial Blood Gases during Stepwise Steady-State Inspired Hypoxia.

PURPOSE

The purpose of this study was to evaluate the accuracy of peripheral oxygen saturation (SpO 2 ) measurements from Polar Elixir™ pulse oximetry technology compared with arterial oxygen saturation (SaO 2 ) measurements during acute stepwise steady-state inspired hypoxia at rest. A post hoc objective was to determine if SpO 2 measurements could be improved by recalibrating the Polar Elixir™ algorithm with SaO 2 values from a random subset of participants.

METHODS

The International Organization for Standardization (ISO) protocol (ISO 80601-2-61:2017) for evaluating the SpO 2 accuracy of pulse oximeter equipment was followed whereby five plateaus of SaO 2 between 70% and 100% were achieved using stepwise reductions in inspired O 2 during supine rest. Blood samples drawn through a radial arterial catheter from 25 participants were first used to compare SaO 2 with SpO 2 measurements from Polar Elixir™. Then the Polar Elixir™ algorithm was recalibrated using SaO 2 data from 13 random participants, and SpO 2 estimates were recalculated for the other 12 participants. For SaO 2 values between 70% and 100%, root mean square error, intraclass correlation coefficients (ICC), Pearson correlations, and Bland-Altman plots were used to assess the accuracy, agreement, and strength of relationship between SaO 2 values and SpO 2 values from Polar Elixir™.

RESULTS

The initial root mean square error for Polar Elixir™ was 4.13%. After recalibrating the algorithm, the RMSE was improved to 2.67%. The ICC revealed excellent levels of agreement between SaO 2 and Polar Elixir™ SpO 2 values both before (ICC(1,3) = 0.837, df = 574, P < 0.001) and after (ICC(1,3) = 0.942, df = 287, P < 0.001) recalibration.

CONCLUSIONS

Relative to ISO standards, Polar Elixir™ yielded accurate SpO 2 measurements during stepwise inspired hypoxia at rest when compared with SaO 2 values, which were improved by recalibrating the algorithm using a subset of the SaO 2 data.