Status:
RECRUITING
Skin Pigment/Pulse Oximeter in Congenital Heart Disease (CHD)
Lead Sponsor:
Icahn School of Medicine at Mount Sinai
Conditions:
Hypoxemia
Skin Pigment
Eligibility:
All Genders
Up to 18 years
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 retro...
Detailed Description
This is a prospective observational study aiming to evaluate the relationship between pulse oximeter accuracy to the measured level of skin pigmentation in pediatric patients with congenital heart dis...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
October 29 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
92 Patients enrolled
Trial Details
Trial ID
NCT06575270
Start Date
October 29 2024
End Date
December 1 2025
Last Update
November 22 2024
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Mount Sinai Hospital
New York, New York, United States, 10029