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

Recruitingn/aAges any - 18 YearsAllIcahn School of Medicine at Mount Sinai
NCT06575270 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * Pediatric patients (age less than 18 years old) with a diagnosis of CHD (cyanotic or acyanotic) who are presenting for cardiac surgery under general anesthesia with planned arterial access. Exclusion Criteria: * Age greater than 18 years old * Emergency surgery * Significant preoperative anemia (hemoglobin \<8.0 g/dL) * Preoperative hemodynamic instability (i.e., \>1 vasoactive infusions or mechanical circulatory support) * The presence of any colored nail polish on the planned site of pulse oximeter placement, planned use of any intravenous dyes intraoperatively, and patient, parent, or guardian refusal.
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What it tests

  • Not listed
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Where

1 site
Mount Sinai Hospital
New York, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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