Actively Recruiting
Skin Pigment/Pulse Oximeter in Congenital Heart Disease (CHD)
Led by Icahn School of Medicine at Mount Sinai · Updated on 2026-02-13
92
Participants Needed
1
Research Sites
87 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Skin Pigment/Pulse Oximeter in Congenital Heart Disease (CHD)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pediatric patients under 18 years old with congenital heart disease (cyanotic or acyanotic)
- Scheduled for cardiac surgery under general anesthesia with planned arterial access
You will not qualify if you...
- Age over 18 years old
- Emergency surgery
- Significant preoperative anemia (hemoglobin less than 8.0 g/dL)
- Preoperative hemodynamic instability requiring more than 1 vasoactive infusion or mechanical circulatory support
- Colored nail polish on the site planned for pulse oximeter placement
- Planned use of intravenous dyes during surgery
- Patient, parent, or guardian refusal to participate
AI-Screening
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Trial Site Locations
Total: 1 location
1
Mount Sinai Hospital
New York, New York, United States, 10029
Actively Recruiting
Research Team
G
Garrett W. Burnett, M.D.
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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