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Evaluating Pulse Oximeter Accuracy and Skin Color in Children

This study is looking at how accurate pulse oximeters (devices that measure oxygen in your blood through your skin) are for children with different skin colors. Sometimes, skin color might affect how well these devices work. Researchers will compare pulse oximeter readings to a more precise blood test measurement during a cardiac catheterization procedure (a common heart procedure). This study aims to understand if skin color impacts pulse oximeter accuracy in children aged 1 month to 18 years who are already undergoing this procedure. The goal is to improve our understanding of how these important medical devices work for all children.

Study design
This is an observational study involving about 650 children. It is not testing a new treatment, but rather observing existing medical practices.
What's involved
If your child participates, the study team will record information already collected during their cardiac catheterization procedure, including pulse oximeter readings and blood oxygen levels. They will also objectively measure your child's skin color.
Compensation
Not stated in the trial record.
Follow-up
This is a cross-sectional study, meaning data is collected once during the cardiac catheterization procedure. Participants are not followed long-term.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06529575

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

Recruiting
Not specifiedAges 4–18Observational
University of Pennsylvania
~650 participants
Updated 2025-09-12 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Pulse Oximeter Bias
Measured over The variables used to calculate Pulse Oximeter Bias are collected once during the cardiac catheterization procedure. This is a cross-sectional observational study; participants are not followed longitudinally.

Conditions

Pediatric ALL
Cardiac Defect

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NCT06529575

Where you'd take part

This study runs at 3 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Children's Hospital of Philadelphia

    Philadelphia, Pennsylvaniastudy coordinator listed

    Recruiting

  • Columbia University Medical Center

    New York, New Yorkstudy coordinator listed

    Not yet recruiting

  • Texas Children's Hospital

    Houston, Texasstudy coordinator listed

    Not yet recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Halley Ruppel, PhD · PRINCIPAL_INVESTIGATOR · University of Pennsylvania
  • Michael O'Byrne, MD, MSCE · PRINCIPAL_INVESTIGATOR · Children's Hospital of Philadelphia

Who to contact

Halley Ruppel, PhD
[email protected]
267-426-0220
Email the study team

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Eligibility criteria

Inclusion

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

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)

What this trial measures

  • Pulse Oximeter BiasThe variables used to calculate Pulse Oximeter Bias are collected once during the cardiac catheterization procedure. This is a cross-sectional observational study; participants are not followed longitudinally.

    Pulse oximeter bias is the difference between the pulse oximeter value (estimated % oxygen saturation measured via pulse oximeter) and the gold standard measure of arterial oxygen saturation (% oxygen saturation in blood sample measured via co-oximeter).