Evaluating pulse oximeter accuracy in children with congenital heart disease
Official title: Pulse Oximetry Accuracy and Skin Pigmentation in Congenital Heart Disease: A Prospective Observational Study
Run by Icahn School of Medicine at Mount Sinai · NCT06575270 · Data updated 2026-11-12
This study is testing how accurate pulse oximeters are for children with congenital heart disease, especially looking at how skin color might affect their readings before surgery.
Quick facts
| Study type | Observational |
|---|---|
| Ages | Any age to 18 Years |
| Sex | All |
| Enrollment | 24 (estimated) |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Status | Recruiting |
| Started | October 29, 2024 |
| Main results expected | August 31, 2027 |
| Study ends | August 31, 2027 |
| Registry record updated | September 25, 2026 |
| Trial ID | NCT06575270 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are pediatric patients under 18 years old with a diagnosis of congenital heart disease who are scheduled for cardiac surgery.
✕Probably not a fit
Patients over 18 years old, those undergoing emergency surgery, or individuals with significant preoperative anemia or hemodynamic instability 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 observational study aims to prospectively assess the accuracy of pulse oximeters in relation to skin pigmentation levels in pediatric patients diagnosed with congenital heart disease (CHD). The study will involve measuring skin pigmentation using a non-invasive device prior to cardiac surgery and comparing pulse oximeter readings with arterial blood gas measurements taken during the procedure. By focusing on this population, the study seeks to address potential disparities in pulse oximeter accuracy that may affect patient safety. The findings could provide valuable insights into how skin color impacts the reliability of pulse oximetry in clinical settings.
Why it matters
Potential benefit: If successful, this study could improve the accuracy of pulse oximetry readings in children with congenital heart disease, leading to better patient outcomes.
How similar studies have gone: While some retrospective studies have indicated disparities in pulse oximeter accuracy based on skin pigmentation, this prospective approach is relatively novel and has not been extensively tested.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Pediatric patients (age less than 18 years old) with a diagnosis of CHD (cyanotic or acyanotic) who are presenting for cardiac surgery under general anesthesia with planned arterial access. Exclusion Criteria: * Age greater than 18 years old * Emergency surgery * Significant preoperative anemia (hemoglobin \<8.0 g/dL) * Preoperative hemodynamic instability (i.e., \>1 vasoactive infusions or mechanical circulatory support) * The presence of any colored nail polish on the planned site of pulse oximeter placement, planned use of any intravenous dyes intraoperatively, and patient, parent, or guardian refusal.
Where it's running
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Mount Sinai Hospital
New York, New York, United States Recruiting
Study contacts
- Principal investigator: Garrett W. Burnett, M.D. — Icahn School of Medicine at Mount Sinai
- Study coordinator: Garrett W. Burnett, M.D.
- Email: garrett.burnett@mountsinai.org
- Phone: 212-241-7473
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.