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
Sites (3)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Texas Children's Hospital Coordinator of this site? Confirm its status | Houston | United States | Not yet recruiting |
| Columbia University Medical Center Coordinator of this site? Confirm its status | New York | United States | Not yet recruiting |
| Children's Hospital of Philadelphia Coordinator of this site? Confirm its status | Philadelphia | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.