Skin Pigment/Pulse Oximeter in Congenital Heart Disease (CHD)
Pulse Oximetry Accuracy and Skin Pigmentation in Congenital Heart Disease: A Prospective Observational Study
- Hypoxemia
- Skin Pigment
- Congenital Heart Disease
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Enrolment target
- 24
- Started
- 29 October 2024
- Main results due
- 31 August 2027
- Study sites
- 1
- Registry updated
- 25 September 2026
Can you take part?
- Up to 18 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.
What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(1)
Mount Sinai Hospital
New York, New York, United States
Recruiting
Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT06575270. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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