Summary

Eligibility
for people ages up to 21 years (full criteria)
Location
at UCSF
Dates
study started
completion around

Description

Summary

In this prospective study, the investigators will enroll 154 children with arterial lines to determine the accuracy of pulse oximeters in children with darker skin pigmentation. Studies in adults suggest pulse oximeters may overestimate the true level of oxygenation in the blood as measured directly by co-oximetry. However, pediatric data are relatively limited. This study, which is funded by the FDA through the Stanford-UCSF (University of California San Francisco) Clinical Excellence in Regulatory Science and Innovation (CERSI) Program, will determine if the error/bias is associated with skin pigmentation and whether the error falls outside FDA standards. The broader purpose of the study is to work toward eliminating health disparities.

Official Title

Prospective Clinical Study to Evaluate the Accuracy of Pulse Oximeters in Children With Darker Skin Pigmentation

Details

Keywords

Congenital Heart Disease in Children, Cardiomyopathies, Heart Diseases, Congenital Heart Defects, Pulse Oximeter (Massimo)

Eligibility

Location

  • Lucile Packard Children's Hospital accepting new patients
    Palo Alto California 94304 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Stanford University
ID
NCT05617547
Study Type
Observational
Participants
Expecting 154 study participants
Last Updated