Actively Recruiting
Led by University of Pennsylvania · Updated on 2025-09-12
650
Participants Needed
3
Research Sites
N/A
Total Duration
U
University of Pennsylvania
Lead Sponsor
C
Children's Hospital of Philadelphia
Collaborating Sponsor
This research aims to understand how pulse oximeter accuracy varies among children with different skin colors during real-world clinical use. The study focuses on children undergoing cardiac catheterization, a group with varied baseline arterial oxygen levels due to their heart conditions. By objectively measuring skin color and comparing pulse oximeter readings to direct blood oxygen measurements, the study seeks to address limitations of earlier research and improve knowledge about pulse oximeter accuracy in pediatric patients. The study is observational and will take place at multiple sites, involving children under 18 years old who are having cardiac catheterization. Skin color will be measured using spectrophotometry to capture multiple dimensions such as melanin and redness. During the procedure, data collected as part of routine care, including pulse oximeter readings and arterial blood oxygen levels measured by co-oximeter, will be recorded by the study team for analysis. Participants will be monitored continuously with pulse oximeters during catheterization, and the primary measurement will be the difference between the pulse oximeter reading and direct arterial oxygen measurement. This information is collected once during the procedure, and there is no long-term follow-up. The study will contribute important insights into how skin color affects pulse oximeter accuracy in children, helping to inform clinical care.
CONDITIONS
Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
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Complete this quick 3-step screening to check your eligibility
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Procedure day
Participants undergo cardiac catheterization during which pulse oximeter readings and direct arterial oxygen saturation measurements are collected as part of routine care. Skin color measurements are also taken using spectrophotometry.
1 visit (in-person)
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
H
Halley Ruppel, PhD
M
Michelle Dunn
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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Halley Ruppel, Liming Huang, Christopher J Petit...
https://pubmed.ncbi.nlm.nih.gov/40187780