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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeUp to 18
SponsorIcahn School of Medicine at Mount Sinai

About this trial

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

Qualifiers

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.

Disqualifiers

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)

Trial design

Treatments tested in this trial

  • Not listed

Trial groups

92 Participants
are grouped into 1 trial group