NCT06575270 Skin Pigment/Pulse Oximeter in Congenital Heart Disease (CHD)
| NCT ID | NCT06575270 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Icahn School of Medicine at Mount Sinai |
| Condition | Hypoxemia |
| Study Type | OBSERVATIONAL |
| Enrollment | 92 participants |
| Start Date | 2024-10-29 |
| Primary Completion | 2026-07 |
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 92 participants in total. It began in 2024-10-29 with a primary completion date of 2026-07.
⚠ 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
Recent retrospective studies have demonstrated differences between pulse oximeter values (SpO2) and measured arterial oxygen saturation (SaO2) in patients identifying as Black or Hispanic. These retrospective studies have limitations because self-reported race is likely not an accurate metric for level of skin pigmentation and the retrospective nature of these studies may impact the accuracy of simultaneous measures of arterial oxygen saturation and pulse oximeter values. The few prospective studies that have evaluated this issue have utilized color-matching techniques to quantify skin pigmentation, and fewer studies have directly measured skin pigmentation in relation it to pulse oximeter accuracy. The aim of this study is to prospectively measure pulse oximeter accuracy in relation to measured levels of skin pigmentation in the congenital heart disease population.
Eligibility 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.
Contact & Investigator
Garrett W. Burnett, M.D.
PRINCIPAL INVESTIGATOR
Icahn School of Medicine at Mount Sinai
Frequently Asked Questions
Who can join the NCT06575270 clinical trial?
This trial is open to participants of all sexes, up to 18 Years, studying Hypoxemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06575270 currently recruiting?
Yes, NCT06575270 is actively recruiting participants. Contact the research team at garrett.burnett@mountsinai.org for enrollment information.
Where is the NCT06575270 trial being conducted?
This trial is being conducted at New York, United States.
Who is sponsoring the NCT06575270 clinical trial?
NCT06575270 is sponsored by Icahn School of Medicine at Mount Sinai. The principal investigator is Garrett W. Burnett, M.D. at Icahn School of Medicine at Mount Sinai. The trial plans to enroll 92 participants.