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

NCT06575270 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 92

Last updated 2026-02-13

No results posted yet for this study

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.

Conditions

  • Hypoxemia
  • Skin Pigment
  • Congenital Heart Disease

Sponsors & Collaborators

Principal Investigators

  • Garrett W. Burnett, M.D. · Icahn School of Medicine at Mount Sinai

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-29
Primary Completion
2026-07-31
Completion
2026-07-31

Countries

  • United States

Study Locations

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Entities

Companies

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 NCT06575270 on ClinicalTrials.gov