Evaluating Pulse Oximetry Bias in Children With Darker Skin Pigmentation

In this prospective study, the investigators will enroll 154 children with arterial lines to determine the accuracy of pulse oximeters in children with darker skin pigmentation. Studies in adults suggest pulse oximeters may overestimate the true level of oxygenation in the blood as measured directly by co-oximetry. However, pediatric data are relatively limited. This study, which is funded by the FDA through the Stanford-UCSF (University of California San Francisco) Clinical Excellence in Regulatory Science and Innovation (CERSI) Program, will determine if the error/bias is associated with skin pigmentation and whether the error falls outside FDA standards. The broader purpose of the study is to work toward eliminating health disparities.

Inclusion Criteria:Age ≤21 years of ageRequires arterial vascular access as part of routine clinical carePatient or legally authorized representative (LAR) willing to provide written informed consentExclusion Criteria:Anemia defined as a Hgb <8 g/dLMethemoglobinemia or carbon monoxide poisoning where the SpO2 is known to be inaccurateSkin condition, such as epidermolysis bullosa, where pulse oximetry not expected to be accurate, or application of skin probes is medically inadvisableNon-pulsatile patients (e.g., left ventricular assist device (LVAD), extracorporeal membrane oxygenation (ECMO)Lack of informed consent