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Pulse Oximeter Accuracy in Critically Ill Children with Diverse Skin Tones: Protocol of a Prospective Observational Study
Shubhada Hooli;
R. Brandon Hunter;
Gina Aloisio;
Mubbasheer Ahmed;
Elizabeth Camp;
Andre Gie;
Nabeeha Engineer;
Ida Orengo;
Anna Mandalakas;
Tim Colbourn;
Manish I. Shah;
Eric D. McCollum
ABSTRACT
Background:
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.
Objective:
To determine if the Nellcor Oximax pulse oximeter has differential accuracy when used in critically ill children with fair, medium, and dark skin tones.
Methods:
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.
Results:
At this time, we have no results to report, though we are actively enrolling patients.
Conclusions:
Results will be shared in peer-reviewed journals, conferences, and lay summaries for the public and other stakeholders.
Citation
Please cite as:
Hooli S, Hunter RB, Aloisio G, Ahmed M, Camp E, Gie A, Engineer N, Orengo I, Mandalakas A, Colbourn T, Shah MI, McCollum ED
Pulse Oximeter Accuracy in Critically Ill Children with Diverse Skin Tones: Protocol of a Prospective Observational Study
JMIR Research Protocols. 30/10/2026:104645 (forthcoming/in press)