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

Mount Sinai Health System

Status: Enrolling

Conditions: Congenital Heart Disease; Skin Pigment; Hypoxemia

Study type: Observational

Funder types: Other

Identifiers

NCT06575270

STUDY-23-00956

TE00003017 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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 disease (CHD). These patients live with varying levels of hypoxemia, making them an ideal study population to investigate this critical patient safety issue. The study population will be pediatric patients (age <18 years old) with a diagnosis of congenital heart disease presenting for cardiac surgery at the Mount Sinai Hospital. These patient's will undergo surgery as per protocol, as if they were not in a research study, but will have their skin pigment measured using a non-invasive device (color spectrophotometer) prior to surgery. As part of the normal surgery protocols, arterial blood gas samples will be completed. The measured oxygen levels (SaO2) on arterial blood gas will be compared to the pulse oximeter value using simultaneous measurements to ensure the measures are concurrent. After cardiopulmonary bypass is initiated for the surgery, the subject's involvement in the study will be completed.

Enrollment: 92 estimated patients

Sex: All

Ages: Under 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

92 participants in 1 patient group

Pediatric Patients with Congenital Heart Disease

Description:

No intervention will take place in this observational study. All patients will have their skin pigment measured using a color spectrophotometer and color matching techniques (Fitzpatrick Scale, Monk Skin Tone Scale). Two pulse oximeters will be utilized and pulse oximeter readings will be compared to simultaneous measured arterial saturations. After cardiopulmonary bypass is initiated for the surgery, the subject's involvement in the study will be completed.