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Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children

RECRUITINGSponsored by University of Pennsylvania
Actively Recruiting
SponsorUniversity of Pennsylvania
Started2024-08-14
Est. completion2028-12
Eligibility
Age4 Weeks – 18 Years
Healthy vol.Accepted
Locations3 sites

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 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.

Eligibility

Age: 4 Weeks – 18 YearsHealthy volunteers accepted
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)

Conditions4

CancerCardiac DefectHeart DiseasePediatric ALL

Locations3 sites

New York

1 site
Columbia University Medical Center
New York, New York, 10032
Christopher Petit, MDcjp2196@cumc.columbia.edu

Pennsylvania

1 site
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Michael O'Byrne, MDobyrnem@chop.edu

Texas

1 site
Texas Children's Hospital
Houston, Texas, 77030

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