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Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
Who can join
4 Weeks – 18 Years · All sexes
Full eligibility criteria
Inclusion Criteria: * Child is between 1 month and 18 years old * Child is undergoing a cardiac catheterization procedure that typically involves direct arterial oxygen saturation measurement by co-oximeter from a location reflective of systemic saturation. Exclusion Criteria: * Child previously participated in the study * Child has differential cyanosis across extremities * Child is receiving an intravenous vasoconstrictor prior to procedure * Child has a ventricular assist device (VAD)
About the study
This multisite study seeks to understand whether and how pulse oximeter accuracy varies across children with different skin colors in real world clinical settings. Many factors can affect how well pulse oximeters work; for example, movement and even fingernail polish. Some studies in adults show that skin color may also affect the pulse oximeter reading. In this study, we will explore pulse oximeter accuracy in children of all skin colors who are undergoing cardiac catheterizations. The study will address limitations of prior work by objectively measuring skin color across multiple dimensions of color and comparing the the pulse oximeter reading to the "gold standard" blood sample measurement.
Sponsor: University of Pennsylvania · Participants: 650 · Started: Aug 14, 2024
Contact the study team
- Halley Ruppel, PhD · Phone: 267-426-0220
- Michelle Dunn · Phone: 8324445631
Official record on ClinicalTrials.gov — NCT06529575
Locations in the U.S.
| New York | Columbia University Medical Center, New York (Not yet recruiting) |
| Pennsylvania | Children's Hospital of Philadelphia, Philadelphia |
| Texas | Texas Children's Hospital, Houston (Not yet recruiting) |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.