Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
PACH
2 other identifiers
observational
650
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2024
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 22, 2024
CompletedFirst Posted
Study publicly available on registry
July 31, 2024
CompletedStudy Start
First participant enrolled
August 14, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
September 12, 2025
September 1, 2025
4.3 years
July 22, 2024
September 5, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Pulse Oximeter Bias
Pulse oximeter bias is the difference between the pulse oximeter value (estimated % oxygen saturation measured via pulse oximeter) and the gold standard measure of arterial oxygen saturation (% oxygen saturation in blood sample measured via co-oximeter).
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.
Eligibility Criteria
Children who are old undergoing a cardiac catheterization procedure at one of the data collection sites and is having a procedure that typically involves direct arterial oxygen saturation measurement by co-oximeter from a location reflective of systemic saturation.
You may qualify if:
- 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.
You may not qualify if:
- 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 the study team to confirm eligibility.
Sponsors & Collaborators
- University of Pennsylvanialead
- Children's Hospital of Philadelphiacollaborator
- Baylor College of Medicinecollaborator
- Columbia Universitycollaborator
- National Heart, Lung, and Blood Institute (NHLBI)collaborator
Study Sites (3)
Columbia University Medical Center
New York, New York, 10032, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Related Publications (1)
Ruppel H, Huang L, Petit CJ, Qureshi AM, Bonafide CP, Foglia EE, Feldman J, Lane-Fall MB, Lynch JM, Chien A, Dunn M, O'Byrne ML. Protocol for a multisite, observational clinical study of the association between skin colour and pulse oximeter accuracy in children undergoing cardiac catheterisation (PACH study). BMJ Open. 2025 Apr 5;15(4):e100391. doi: 10.1136/bmjopen-2025-100391.
PMID: 40187780DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Halley Ruppel, PhD
University of Pennsylvania
- PRINCIPAL INVESTIGATOR
Michael O'Byrne, MD, MSCE
Children's Hospital of Philadelphia
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 22, 2024
First Posted
July 31, 2024
Study Start
August 14, 2024
Primary Completion (Estimated)
December 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
September 12, 2025
Record last verified: 2025-09
Data Sharing
- IPD Sharing
- Will share
Per NIH Data Management and Sharing Policy, study data will be contributed to a repository available to other researchers. Study data will be de-identified.