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RECRUITING
NCT06575270

Skin Pigment/Pulse Oximeter in Congenital Heart Disease (CHD)

Sponsor: Icahn School of Medicine at Mount Sinai

View on ClinicalTrials.gov

Summary

Recent retrospective studies have demonstrated differences between pulse oximeter values (SpO2) and measured arterial oxygen saturation (SaO2) in patients identifying as Black or Hispanic. These retrospective studies have limitations because self-reported race is likely not an accurate metric for level of skin pigmentation and the retrospective nature of these studies may impact the accuracy of simultaneous measures of arterial oxygen saturation and pulse oximeter values. The few prospective studies that have evaluated this issue have utilized color-matching techniques to quantify skin pigmentation, and fewer studies have directly measured skin pigmentation in relation it to pulse oximeter accuracy. The aim of this study is to prospectively measure pulse oximeter accuracy in relation to measured levels of skin pigmentation in the congenital heart disease population.

Official title: Pulse Oximetry Accuracy and Skin Pigmentation in Congenital Heart Disease: A Prospective Observational Study

Key Details

Gender

All

Age Range

Any - 18 Years

Study Type

OBSERVATIONAL

Enrollment

92

Start Date

2024-10-29

Completion Date

2026-07

Last Updated

2026-02-13

Healthy Volunteers

No

Locations (1)

Mount Sinai Hospital

New York, New York, United States