About this trial
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 criteria
Qualifiers
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.
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Not listed
Trial groups
Sponsors and collaborators
University of Pennsylvania
Lead sponsor
Children's Hospital of Philadelphia
Collaborator
Baylor College of Medicine
Collaborator
Columbia University
Collaborator
National Heart, Lung, and Blood Institute (NHLBI)
Collaborator