Recruiting

Observational Study

Sponsor:

University of Pennsylvania

Code:

NCT06529575

Conditions

Pediatric ALL

Cardiac Defect

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

Study Details

Brief summary:

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.

Conditions

Pediatric ALL

Cardiac Defect

Study ID

NCT06529575

Start date

Aug 14, 2024

Status verified date

Sep, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

Dec, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0 - 18

Healthy Volunteers: Not accepted

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)

Study Design

Enrollment

650 participants

Anticipated

Interventions and Outcome Measures

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 and Locations

Central contacts

Halley Ruppel, PhD

267-426-0220hruppel@nursing.upenn.edu

Michelle Dunn

8324445631medpenn@nursing.upenn.edu

Locations

Children's Hospital of Philadelphia

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Michael O'Byrne, MD

obyrnem@chop.edu

More Information

Sponsor

University of Pennsylvania

Last update posted

Sep 24, 2026

Last verified

Sep, 2026

Keywords

  • Pulse Oximetry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-23. This information was provided to ClinicalTrials.gov by University of Pennsylvania on 2026-09-24. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.