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NCT06529575Recruiting

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

Source: ClinicalTrials.gov · Last updated 24 Sept 2026

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Study type
Observational
Enrollment
650 (estimated)
First submitted
22 Jul 2024
Start date
14 Aug 2024
Primary completion date
Dec 2028
Lead sponsor
University of Pennsylvania
NCT number
NCT06529575

What you commit to

  • Study type: Observational
  • Planned participants: 650
  • From 14 Aug 2024 to the primary completion date, Dec 2028
  • 3 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Child previously participated in the study
  • Child is receiving an intravenous vasoconstrictor prior to procedure

Other

  • Child has differential cyanosis across extremities
  • Child has a ventricular assist device (VAD)

Who the study is looking for

  • Child is between 1 month and 18 years old
  • Child is undergoing a cardiac catheterization procedure that typically involves direct arterial oxygen saturation measurement by co-oximeter from a location reflective of systemic saturation.

Age in the registry: 4 weeks to 18 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (3)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Texas Children's Hospital
Coordinator of this site? Confirm its status
HoustonUnited StatesNot yet recruiting
Columbia University Medical Center
Coordinator of this site? Confirm its status
New YorkUnited StatesNot yet recruiting
Children's Hospital of Philadelphia
Coordinator of this site? Confirm its status
PhiladelphiaUnited StatesRecruiting

This page is information, not medical advice. Discuss any trial with your doctor.