Status:
RECRUITING
Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
Lead Sponsor:
University of Pennsylvania
Collaborating Sponsors:
Children's Hospital of Philadelphia
Baylor College of Medicine
Conditions:
Pediatric ALL
Cardiac Defect
Eligibility:
All Genders
4-18 years
Brief Summary
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 pul...
Detailed Description
This multisite, prospective, observational study will be conducted in a population of children under 18 years old who are undergoing cardiac catheterization. The primary aim of the study is to quantif...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 14 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2028
Estimated Enrollment :
650 Patients enrolled
Trial Details
Trial ID
NCT06529575
Start Date
August 14 2024
End Date
December 1 2028
Last Update
September 12 2025
Active Locations (3)
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1
Columbia University Medical Center
New York, New York, United States, 10032
2
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
3
Texas Children's Hospital
Houston, Texas, United States, 77030