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Checking whether skin color affects pulse oximeter accuracy in children

Compares pulse oximeter readings with blood tests in children having heart catheterization.

Key facts

Who runs it
University of Pennsylvania
Where
Houston, New York, and Philadelphia, United StatesSee the 3 sites
Trial code
Registry title
Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
Status
Recruiting
People taking part
650 people, planned
Started
14 Aug 2024
Expected to end
Dec 2028
Type of study
Observational
Record updated
24 September 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children of all skin colors who are having a cardiac catheterization. It checks how accurate pulse oximeters are across skin colors.

Age
From 1 month to 18 years old.
Sex
All sexes can join.
Disease stage
Children undergoing a cardiac catheterization procedure that usually includes a direct arterial oxygen saturation measurement by co-oximeter.
Earlier treatment
Must not have received an intravenous vasoconstrictor before the procedure.

Main reasons for not taking part

  • Took part in this study before
  • Has differential cyanosis across extremities
  • Received an intravenous vasoconstrictor before the procedure
  • Has a ventricular assist device (VAD)

The registry criteria, word for word

Show all 6 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • Child previously participated in the study
  • Child is receiving an intravenous vasoconstrictor prior to procedure
  • Child has differential cyanosis across extremities
  • Child has a ventricular assist device (VAD)

Where in United States

  • Texas Children's HospitalHouston, United StatesContact: Athar Qureshi, MDNot yet recruiting
  • Columbia University Medical CenterNew York, United StatesContact: Christopher Petit, MDNot yet recruiting
  • Children's Hospital of PhiladelphiaPhiladelphia, United StatesContact: Michael O'Byrne, MDTaking people

About the trial

What the trial wants to find out

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.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

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Data and sources

Registry record
Listed on ClinicalTrials.gov.
Official title
Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
Plain-language title
Checking whether skin color affects pulse oximeter accuracy in childrenGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
24 September 2026