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

Part of paid clinical trials in New York, New York.

Sponsor
Icahn School of Medicine at Mount Sinai
Study ID
NCT06575270
Status
Recruiting
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Conditions

  • Congenital Heart Disease
  • Hypoxemia
  • Skin Pigment

Eligibility Criteria

Sex
ALL
Age
N/A - 18 Years
Healthy Volunteers
Not accepted

Study Details

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.

Key Dates

Start date
Oct 29, 2024
Status verified
Feb 2026
Primary completion
Jul 31, 2026
Completion
Jul 31, 2026

Study Design

Enrollment
92 participants (estimated)

Arms

  • Arm: 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

Locations (1)

FacilityCityStateZIPSite coordinators
Mount Sinai HospitalNew YorkNew York10029
Garrett W. Burnett, M.D.
[email protected]
212-241-7473
Garrett W. Burnett (PRINCIPAL_INVESTIGATOR)

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By research site
Mount Sinai Hospital· New York, NY

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