NCT06575270

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

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

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 92 (estimated)
• Sponsor: Icahn School of Medicine at Mount Sinai · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a prospective observational study aiming to evaluate the relationship between pulse oximeter accuracy to the measured level of skin pigmentation in pediatric patients with congenital heart disease (CHD). These patients live with varying levels of hypoxemia, making them an ideal study population to investigate this critical patient safety issue. The study population will be pediatric patients (age \<18 years old) with a diagnosis of congenital heart disease presenting for cardiac surgery at the Mount Sinai Hospital. These patient's will undergo surgery as per protocol, as if they were not in a research study, but will have their skin pigment measured using a non-invasive device (color spectrophotometer) prior to surgery. As part of the normal surgery protocols, arterial blood gas samples will be completed. The measured oxygen levels (SaO2) on arterial blood gas will be compared to the pulse oximeter value using simultaneous measurements to ensure the measures are concurrent. After cardiopulmonary bypass is initiated for the surgery, the subject's involvement in the study will be completed.

Conditions

• Hypoxemia
• Skin Pigment
• Congenital Heart Disease

Timeline

• Start date: 2024-10-29
• Primary completion: 2026-07-01
• Completion: 2026-07-01
• First posted: 2024-08-28
• Last updated: 2026-02-13

Locations

1 site across 1 country: United States