Evaluating pulse oximeter accuracy in children with congenital heart disease
Pulse Oximetry Accuracy and Skin Pigmentation in Congenital Heart Disease: A Prospective Observational Study
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 |
|---|---|
| Enrollment | 92 (estimated) |
| Ages | N/A to 18 Years |
| Sex | All |
| Sponsor | Icahn School of Medicine at Mount Sinai Academic / other |
| Locations | 1 site (New York, New York) |
| Trial ID | NCT06575270 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
New York, New York
- 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
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.