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Effect of Skin Pigmentation and Race/Ethnicity Factors on the Accuracy of Masimo Pulse Oximeters

Masimo Corporation · 2021
ClinicalTrials.gov · Datasets · License: Public Domain · 2021
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This study is designed to compare the accuracy of a noninvasive measurement of oxygen saturation compared to reference values obtained by a laboratory blood gas analyzer. Subgroups will be analyzed by skin pigmentation and self-identified race/ethnicity information. Study procedures follow ISO-80601-2-61:2011 standard requirements for basic safety and essential performance of pulse oximeter equipment. Arterial blood samples will be collected from subjects while undergoing a controlled desaturation procedure wherein the concentration of oxygen inhaled is slowly reduced until the subject's arterial oxygen concentration is approximately 70%.
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