Evaluating Pulse Oximetry Bias in Children With Darker Skin Pigmentation

RecruitingOBSERVATIONAL
Enrollment

154

Participants

Timeline

Start Date

August 31, 2022

Primary Completion Date

October 1, 2024

Study Completion Date

October 1, 2024

Conditions
Congenital Heart Disease in ChildrenCardiomyopathies
Interventions
DIAGNOSTIC_TEST

Pulse Oximeter (Massimo)

The Massimo LNCS (low noise cabled sensors) pulse oximeter will be used to estimate the oxygen saturation and compared to the gold standard, the arterial oxygen saturation in the blood as measured by co-oximetry. The pulse oximeters is FDA cleared for this purpose so patients will not be exposed to any interventions that are not standard of care.

Trial Locations (1)

94304

RECRUITING

Lucile Packard Children's Hospital, Palo Alto

All Listed Sponsors
collaborator

Food and Drug Administration (FDA)

FED

collaborator

University of California, San Francisco

OTHER

lead

Stanford University

OTHER