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

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

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 Overview

• Status: Recruiting
• Conditions: Congenital Heart Disease; Hypoxemia; Skin Pigment

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.

• Study Type: Observational
• Enrollment (Estimated): 92

Contacts and Locations

• Study Contact: Name: Garrett W. Burnett, M.D.; Phone Number: 212-241-7473; Email: garrett.burnett@mountsinai.org

Study Locations

• United States
  • New York
    • New York, New York, United States, 10029
      • Recruiting
      • Mount Sinai Hospital
      • Contact: Garrett W. Burnett, M.D.; Phone Number: 212-241-7473; Email: garrett.burnett@mountsinai.org
      • Principal Investigator: Garrett W. Burnett

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric patients with a past medical history of congenital heart disease presenting for cardiac surgery under general anesthesia with anticipated arterial vascular access.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Pediatric Patients with Congenital Heart Disease; No intervention will take place in this observational study. All patients will have their skin pigment measured using a color spectrophotometer and color matching techniques (Fitzpatrick Scale, Monk Skin Tone Scale). Two pulse oximeters will be utilized and pulse oximeter readings will be compared to simultaneous measured arterial saturations. After cardiopulmonary bypass is initiated for the surgery, the subject's involvement in the study will be completed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Level of Skin Pigmentation	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).	Day 1 of study participation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fitzpatrick Skin Tone Scale	Pulse Oximeter Accuracy in measuring skin pigmentation as measured by Fitzpatrick Skin Tone Scale Pulse oximeter accuracy as it relates to level of skin pigmentation as measured by Fitzpatrick Scale. Scale from I-VI, with higher number indicating darker skin tone	Day 1 of study participation
Monk Skin Tone Scale	Pulse oximeter accuracy as it relates to level of skin pigmentation as measured by Monk Skin Tone Scale. Scale from 1-10, higher numbers indicates darker skin tone.	Day 1 of study participation
Number of participants who experience at least one episode of occult hypoxemia	Incidence of occult hypoxemia, defined as SpO2 ≥92% despite SaO2≤88%, as it relates to measured skin pigment and incidence of occult hypoxemia will be described. Incidence will be measured by assessing the total number of participants who experience at least one episode of occult hypoxemia.	Day 1 of study participation

Collaborators and Investigators

• Sponsor: Icahn School of Medicine at Mount Sinai
• Investigators: Principal Investigator: Garrett W. Burnett, M.D., Icahn School of Medicine at Mount Sinai

Study record dates

Study Major Dates

• Study Start (Actual): October 29, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026

Study Registration Dates

• First Submitted: August 26, 2024
• First Submitted That Met QC Criteria: August 26, 2024
• First Posted (Actual): August 28, 2024

Study Record Updates

• Last Update Posted (Actual): February 13, 2026
• Last Update Submitted That Met QC Criteria: February 11, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Congenital Heart Disease; Pulse Oximetry; Hypoxemia; Skin Pigment
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Skin Diseases; Congenital Abnormalities; Signs and Symptoms, Respiratory; Cardiovascular Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Heart Defects, Congenital; Hypoxia; Pigmentation Disorders
• Other Study ID Numbers: STUDY-23-00956; TE00003017 (Other Grant/Funding Number: Anesthesia Patient Safety Foundation)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: All of the individual participant data collected during the trial, after deidentification.
• IPD Sharing Time Frame: Upon study completion and in accordance with any peer-reviewed journal requirements.
• IPD Sharing Access Criteria: Researchers who provide a methodologically sound proposal. To achieve aims in the approved proposal. Proposals should be directed to garrett.burnett@mountsinai.org. To gain access, data requestors will need to sign a data access agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; ANALYTIC_CODE; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No