Clinical trial Recruiting at 1 site Observational Ages 4 Weeks to 18

Examining how skin color affects pulse oximeter accuracy in children

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

Run by University of Pennsylvania · NCT06529575 · Data updated 2026-11-12

This study is testing how well pulse oximeters work for children with different skin colors during heart procedures to see if their readings are accurate.

Quick facts

Study typeObservational
Ages4 Weeks to 18 Years
SexAll
Enrollment650 (estimated)
SponsorUniversity of Pennsylvania
Academic / other
Locations3 sites (New York, New York and 2 other locations)
StatusRecruiting
StartedAugust 14, 2024
Main results expectedDecember 2028
Study endsDecember 2028
Registry record updatedSeptember 24, 2026
Trial IDNCT06529575 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates for this study are children aged 1 month to 18 years who are undergoing cardiac catheterization procedures.

Probably not a fit

Patients who have differential cyanosis across extremities or are receiving intravenous vasoconstrictors may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This multisite observational study aims to evaluate the accuracy of pulse oximeters in children of varying skin colors undergoing cardiac catheterization. By objectively measuring skin color and comparing pulse oximeter readings to direct arterial blood oxygen measurements, the study seeks to identify any discrepancies in accuracy. The research will involve children under 18 years old and will utilize clinical data collected during routine care to assess the performance of pulse oximeters across different skin tones. The findings could provide valuable insights into the clinical implications of pulse oximeter use in pediatric populations.

Why it matters

Potential benefit: If successful, this study could lead to improved pulse oximeter accuracy and better clinical outcomes for children with varying skin colors.

How similar studies have gone: Previous studies in adults have suggested that skin color may impact pulse oximeter readings, but this specific approach in children is novel.

Who can join: the full rules

Show full inclusion / exclusion criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

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

Where it's running

  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania, United States
    Recruiting
  • Columbia University Medical Center
    New York, New York, United States
    Not yet recruiting
  • Texas Children's Hospital
    Houston, Texas, United States
    Not yet recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.