Quantitative analysis of the effect of fraction of inspired oxygen on peripheral oxygen saturation in healthy volunteers

Background: The international organization for standardization (ISO) 80601-2-61 dictates that the accuracy of a pulse oximeter should be assessed by a controlled desaturation study. We aimed to characterize the relationship between the fraction of inspired oxygen (FiO₂) and peripheral oxygen saturation (SpO₂) using a turnover model by retrospectively analyzing the data obtained from previous controlled desaturation studies. Materials and Methods: Each volunteer was placed in a semi-Fowler's position and connected to a breathing circuit to administer the hypoxic gas mixture containing medical air, oxygen, nitrogen, and carbon dioxide. Volunteers were exposed to various levels of induced hypoxia over 70-100% arterial oxygen saturation (SaO₂). The study period consisted of two rounds of hypoxia and the volunteers were maintained in room air between each round. FiO₂ and SpO₂ were recorded continuously during the study period. A population pharmacodynamic analysis was performed with the NONMEM VII level 4 (ICON Development Solutions, Ellicott City, MD, USA). Results: In total, 2899 SpO₂ data points obtained from 20 volunteers were used to determine the pharmacodynamic characteristics. The pharmacodynamic parameters were as follows: k_out = 0.942 1/min, Imax = 0.802, IC₅₀ = 85.3%, γ = 27.3. Conclusion: The changes in SpO₂ due to decreases in FiO₂ well explained by the turnover model with inhibitory function as a sigmoidal model.