RecruitingNCT06529575

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

Sponsor

University of Pennsylvania

Enrollment

650 participants

Start Date

Aug 14, 2024

Study Type

OBSERVATIONAL

Conditions

Pediatric ALL Cardiac Defect

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.

Eligibility

Min Age: 4 WeeksMax Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is investigating whether pulse oximeters (the small clips used to measure blood oxygen levels) give different accuracy readings in children with different skin tones. There have been concerns that these devices may be less accurate for people with darker skin, and this study aims to understand and address that issue in children. **You may be eligible if...** - Your child is between 1 month and 18 years old - Your child is already scheduled for a cardiac catheterization procedure (a heart procedure that directly measures oxygen levels in the blood) **You may NOT be eligible if...** - Your child has previously been in this study - Your child is not undergoing a cardiac catheterization that includes direct oxygen saturation measurement Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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