Currently submitted to: JMIR Research Protocols
Date Submitted: Jun 17, 2026
Open Peer Review Period: Jun 17, 2026 - Aug 12, 2026
(currently open for review)
Warning: This is an author submission that is not peer-reviewed or edited. Preprints - unless they show as "accepted" - should not be relied on to guide clinical practice or health-related behavior and should not be reported in news media as established information.
Pulse Oximeter Accuracy in Critically Ill Children with Diverse Skin Tones: Protocol of a Prospective Cross-sectional Study
ABSTRACT
Pulse oximeters may be inaccurate in children who are critically ill and/or have darker skin pigmentation. To date no studies have published accuracy metrics that align with proposed regulatory standards. Our objective is to determine if the Nellcor Oximax pulse oximeter has differential accuracy when used in critically ill children with fair, medium, and dark skin tones. This is a prospective single-center study of critically ill children aged 1 month to 17 years hospitalized in an intensive care unit at Texas Children’s Hospital (Houston, USA) undergoing arterial blood gas analysis. We exclude children with conditions known to affect the accuracy of pulse oximeters. We will report the mean bias between the oxygen saturation from the Nellcor pulse oximeter with wrap probe and arterial co-oximetry, stratified by the child’s skin tone. Skin tone is classified by the Individual Typology Angle measured by a skin colorimeter and Monk Skin Tone scale. The Institutional Review Board of Baylor College of Medicine approved this study (H-53514). Results will be shared in peer reviewed journals, conferences, and lay summaries for the public and other stakeholders.
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