Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
- Pediatric ALL
- Cardiac Defect
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- University of Pennsylvania
- Enrolment target
- 650
- Started
- 14 August 2024
- Main results due
- December 2028
- Study sites
- 3
- Registry updated
- 24 September 2026
Can you take part?
- Ages 4 weeks to 18 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the 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)
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(3)
Columbia University Medical Center
New York, New York, United States
Not yet recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Recruiting
Texas Children's Hospital
Houston, Texas, United States
Not yet recruiting
Showing 3 of 3 sites. 1 of the 3 sites on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06529575. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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