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

NCT06529575 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 650

Last updated 2025-09-12

No results posted yet for this study

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.

Conditions

  • Pediatric ALL
  • Cardiac Defect

Sponsors & Collaborators

Principal Investigators

  • Halley Ruppel, PhD · University of Pennsylvania

  • Michael O'Byrne, MD, MSCE · Children's Hospital of Philadelphia

Eligibility

Min Age
4 Weeks
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-14
Primary Completion
2028-12-31
Completion
2028-12-31

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06529575 on ClinicalTrials.gov