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Skin Pigment and Pulse Oximeter Accuracy in Children with Congenital Heart Disease

This study is looking at how accurate pulse oximeters (devices that measure oxygen in your blood through your skin) are in children with congenital heart disease (heart problems present at birth). We know that skin color might affect how well these devices work. This study will measure your child's skin pigmentation (skin color) with a special device before heart surgery. During surgery, as part of normal care, blood samples will be taken to measure actual oxygen levels. Researchers will then compare these actual oxygen levels to the pulse oximeter readings to see if skin pigmentation affects the accuracy. This study is for children under 18 with congenital heart disease who are having heart surgery. The study aims to understand this issue better to improve patient safety.

Study design
This is an observational study, meaning researchers will collect information without giving any new treatments. It plans to include 92 pediatric patients.
What's involved
Your child will have their skin pigment measured with a non-invasive device before surgery. Arterial blood gas samples will be taken as part of normal surgery protocols.
Compensation
Not stated in the trial record.
Follow-up
Your child's involvement in the study will be completed after cardiopulmonary bypass is initiated for the surgery.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06575270

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

Recruiting
Not specifiedUp to 18Observational
Icahn School of Medicine at Mount Sinai
~92 participants
Updated 2026-02-13 on ClinicalTrials.gov

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Level of Skin Pigmentation
Measured over Day 1 of study participation

Conditions

Hypoxemia
Skin Pigment
Congenital Heart Disease

Explore related trials

Congenital Heart DiseaseHypoxemia

Where it's being run

1 sites across 1 states
New York1

Study leadership

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

Who to contact

Garrett W. Burnett, M.D.
[email protected]
212-241-7473
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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 trial measures

  • Level of Skin PigmentationDay 1 of study participation

    Pulse oximeter accuracy as it relates to level of skin pigmentation as measured by color spectrophotometry. Pulse oximeter accuracy will be measured using the Accuracy Root Mean Squared (ARMS), mean bias, and proportional bias (Bland-Altman).