Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children

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

Sponsor
University of Pennsylvania
Study ID
NCT06529575
Status
Recruiting
Apply to this trial

Conditions

  • Cardiac Defect
  • Pediatric ALL

Eligibility Criteria

Sex
ALL
Age
4 Weeks - 18 Years
Healthy Volunteers
Not accepted

Study Details

This multisite study seeks to understand whether and how pulse oximeter accuracy varies across children with different skin colors in real world clinical settings. Many factors can affect how well pulse oximeters work; for example, movement and even fingernail polish. Some studies in adults show that skin color may also affect the pulse oximeter reading. In this study, we will explore pulse oximeter accuracy in children of all skin colors who are undergoing cardiac catheterizations. The study will address limitations of prior work by objectively measuring skin color across multiple dimensions of color and comparing the the pulse oximeter reading to the "gold standard" blood sample measurement.

Key Dates

Start date
Aug 14, 2024
Status verified
Sep 2025
Primary completion
Dec 31, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
650 participants (estimated)

Primary Outcome Measure

Pulse Oximeter Bias [ Time Frame: The variables used to calculate Pulse Oximeter Bias are collected once during the cardiac catheterization procedure. This is a cross-sectional observational study; participants are not followed longitudinally. ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
Columbia University Medical CenterNew YorkNew York10032
Christopher Petit, MD
[email protected]
Children's Hospital of PhiladelphiaPhiladelphiaPennsylvania19104
Michael O'Byrne, MD
[email protected]
Texas Children's HospitalHoustonTexas77030
Athar Qureshi, MD
[email protected]

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