Examining how skin color affects pulse oximeter accuracy in children
Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
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 type | Observational |
|---|---|
| Enrollment | 650 (estimated) |
| Ages | 4 Weeks to 18 Years |
| Sex | All |
| Sponsor | University of Pennsylvania Academic / other |
| Locations | 3 sites (New York, New York and 2 other locations) |
| Trial ID | NCT06529575 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 1 month to 18 years who are undergoing cardiac catheterization procedures.
Not a fit: Patients who have differential cyanosis across extremities or are receiving intravenous vasoconstrictors may not benefit from this study.
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 performed: Previous studies in adults have suggested that skin color may impact pulse oximeter readings, but this specific approach in children is novel.
Eligibility criteria
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 this trial is running
New York, New York and 2 other locations
- Columbia University Medical Center — New York, New York, United States (Not_yet_recruiting)
- Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States (Recruiting)
- Texas Children's Hospital — Houston, Texas, United States (Not_yet_recruiting)
Study contacts
- Principal investigator: Halley Ruppel, PhD — University of Pennsylvania
- Study coordinator: Halley Ruppel, PhD
- Email: hruppel@nursing.upenn.edu
- Phone: 267-426-0220
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.