Actively Recruiting
Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
Led by University of Pennsylvania · Updated on 2025-09-12
650
Participants Needed
3
Research Sites
224 weeks
Total Duration
On this page
Sponsors
U
University of Pennsylvania
Lead Sponsor
C
Children's Hospital of Philadelphia
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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.
You will not qualify if you...
- 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)
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 3 locations
1
Columbia University Medical Center
New York, New York, United States, 10032
Not Yet Recruiting
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
3
Texas Children's Hospital
Houston, Texas, United States, 77030
Not Yet Recruiting
Research Team
H
Halley Ruppel, PhD
CONTACT
M
Michelle Dunn
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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