Education and Training
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.
Stanford is currently accepting patients for this trial.
Stanford Investigator(s):
Intervention(s):
- diagnostic test: Pulse Oximeter (Massimo)
Eligibility
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
Ages Eligible for Study
N/A - 21 Years
Genders Eligible for Study
All
Now accepting new patients
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Christopher Almond, MD
650-724-2439
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