Recruiting

Observational Study

Sponsor:

Icahn School of Medicine at Mount Sinai

Code:

NCT06575270

Conditions

Hypoxemia

Skin Pigment

Congenital Heart Disease

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Study Details

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

Hypoxemia

Skin Pigment

Congenital Heart Disease

Study ID

NCT06575270

Start date

Oct 29, 2024

Status verified date

Feb, 2026

Completion date

Jul, 2026

Anticipated

Primary completion date

Jul, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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 Design

Enrollment

92 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Primary outcome measure

  • Level of Skin Pigmentation [ Time Frame: Day 1 of study participation ]

Central Contacts and Locations

Central contacts

Garrett W. Burnett, M.D.

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

Locations

Mount Sinai Hospital

Recruiting

New York, New York, United States, 10029

Contacts

Garrett W. Burnett, M.D.

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

Principal Investigator:

Garrett W. Burnett

More Information

Sponsor

Icahn School of Medicine at Mount Sinai

Last update posted

Feb 13, 2026

Last verified

Feb, 2026

Keywords

  • Pulse Oximetry
  • Skin Pigment
  • Congenital Heart Disease
  • Hypoxemia

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Icahn School of Medicine at Mount Sinai on 2026-02-13.