Skin Pigment/Pulse Oximeter in Congenital Heart Disease (CHD)

Launched by ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI · Aug 26, 2024

Keywords

ClinConnect Summary

This clinical trial is studying how accurately pulse oximeters measure blood oxygen levels in children with congenital heart disease (CHD), particularly in relation to their skin color. Recent research has suggested that the readings from these devices might not be as accurate for patients with darker skin tones, but current studies haven't thoroughly examined this issue. By measuring skin pigment directly, this trial aims to provide clearer information about how well pulse oximeters work for different individuals with CHD.

To participate, children under 18 years old who have been diagnosed with CHD and are scheduled for heart surgery under general anesthesia may be eligible. However, those over 18, those undergoing emergency surgery, or those with significant anemia or unstable heart conditions will not be able to join. Participants can expect to have their skin pigmentation measured during the study, which will help researchers understand if and how it affects pulse oximeter accuracy. This study is important because it could lead to better monitoring and care for patients with CHD, ensuring that everyone receives the most accurate assessments of their oxygen levels.

Gender

ALL

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.