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

NCT06575270 | Recruiting

• 2 other identifiers: STUDY-23-00956TE00003017
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Congenital Heart Disease; Hypoxemia; Skin Pigment

Keywords

Pulse Oximetry; Skin Pigment; Congenital Heart Disease; Hypoxemia

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Fitzpatrick Skin Tone Scale

  Day 1 of study participation

• Monk Skin Tone Scale

  Day 1 of study participation

• Number of participants who experience at least one episode of occult hypoxemia

  Day 1 of study participation

Study Arms (1)

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.

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Icahn School of Medicine at Mount Sinai: lead

Study Sites (1)

Mount Sinai Hospital

New York, New York, 10029, United States

RECRUITING

MeSH Terms

Conditions

Hypoxia; Pigmentation Disorders; Heart Defects, Congenital

Condition Hierarchy (Ancestors)

Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Cardiovascular Abnormalities; Cardiovascular Diseases; Heart Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

• Garrett W. Burnett, M.D.

  Icahn School of Medicine at Mount Sinai

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Garrett W. Burnett, M.D.

CONTACT

212-241-7473; garrett.burnett@mountsinai.org

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: August 28, 2024
• Study Start: October 29, 2024
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: February 13, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Upon study completion and in accordance with any peer-reviewed journal requirements.
• 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.

Locations

US (1)