Evaluating Pulse Oximetry Bias in Children With Darker Skin Pigmentation

Trial ID or NCT#

NCT05617547

Status

recruiting iconRECRUITING

Purpose

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.

Official Title

Prospective Clinical Study to Evaluate the Accuracy of Pulse Oximeters in Children With Darker Skin Pigmentation

Eligibility Criteria

Ages Eligible for Study: Younger than 21 Years
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. 1. Age ≤21 years of age2. Requires arterial vascular access as part of routine clinical care3. Patient or legally authorized representative (LAR) willing to provide written informed consent
Exclusion Criteria:
  1. 1. Anemia defined as a Hgb \<8 g/dL2. Methemoglobinemia or carbon monoxide poisoning where the SpO2 is known to be inaccurate3. Skin condition, such as epidermolysis bullosa, where pulse oximetry not expected to be accurate, or application of skin probes is medically inadvisable4. Non-pulsatile patients (e.g., left ventricular assist device (LVAD), extracorporeal membrane oxygenation (ECMO)5. Lack of informed consent

Investigator(s)

Greg Adamson

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Contact

Christopher Almond, MD
650-724-2439