NCT06529575 Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
| NCT ID | NCT06529575 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Pennsylvania |
| Condition | Pediatric ALL |
| Study Type | OBSERVATIONAL |
| Enrollment | 650 participants |
| Start Date | 2024-08-14 |
| Primary Completion | 2028-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 650 participants in total. It began in 2024-08-14 with a primary completion date of 2028-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility 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)
Contact & Investigator
Halley Ruppel, PhD
PRINCIPAL INVESTIGATOR
University of Pennsylvania
Frequently Asked Questions
Who can join the NCT06529575 clinical trial?
This trial is open to participants of all sexes, aged 4 Weeks or older, up to 18 Years, studying Pediatric ALL. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06529575 currently recruiting?
Yes, NCT06529575 is actively recruiting participants. Contact the research team at hruppel@nursing.upenn.edu for enrollment information.
Where is the NCT06529575 trial being conducted?
This trial is being conducted at New York, United States, Philadelphia, United States, Houston, United States.
Who is sponsoring the NCT06529575 clinical trial?
NCT06529575 is sponsored by University of Pennsylvania. The principal investigator is Halley Ruppel, PhD at University of Pennsylvania. The trial plans to enroll 650 participants.