Evaluating Pulse Oximetry Bias in Children With Darker Skin Pigmentation

Launched by STANFORD UNIVERSITY · Nov 14, 2022

Keywords

ClinConnect Summary

This clinical trial is studying how accurately pulse oximeters measure oxygen levels in the blood of children with darker skin pigmentation. Pulse oximeters are devices that clip onto a finger or toe to check oxygen levels, but previous research in adults has shown that these devices can sometimes give misleading results, especially for individuals with darker skin. The goal of this study is to see if the same issues occur in children and to understand if these inaccuracies might be related to skin color. By doing this research, the team hopes to help reduce health disparities and improve care for all children.

To be eligible for this trial, participants must be 21 years old or younger and need an arterial line for their medical care. They also need to have a parent or guardian who can give permission for them to join the study. Children with certain conditions, like low hemoglobin levels or specific skin issues, won't be able to participate. If enrolled, participants will help researchers gather important information about the accuracy of pulse oximeters, which could lead to better health outcomes for kids in the future.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age ≤21 years of age
• • 2. Requires arterial vascular access as part of routine clinical care
• • 3. Patient or legally authorized representative (LAR) willing to provide written informed consent
• Exclusion Criteria:
• • 1. Anemia defined as a Hgb \<8 g/dL
• • 2. Methemoglobinemia or carbon monoxide poisoning where the SpO2 is known to be inaccurate
• • 3. Skin condition, such as epidermolysis bullosa, where pulse oximetry not expected to be accurate, or application of skin probes is medically inadvisable
• • 4. Non-pulsatile patients (e.g., left ventricular assist device (LVAD), extracorporeal membrane oxygenation (ECMO)
• • 5. Lack of informed consent