Clinical trial NCT06575270: Skin Pigment/Pulse Oximeter in Congenital Heart Disease (CHD)
Official title: Pulse Oximetry Accuracy and Skin Pigmentation in Congenital Heart Disease: A Prospective Observational Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hypoxemia
Skin Pigment
Congenital Heart Disease
Keywords: Pulse Oximetry
Skin Pigment
Congenital Heart Disease
Hypoxemia
Lead sponsor: Icahn School of Medicine at Mount Sinai
Sponsor class: OTHER
First posted: 2024-08-28
Enrollment: 92
Sex: ALL
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric patients with a past medical history of congenital heart disease presenting for cardiac surgery under general anesthesia with anticipated arterial vascular access.

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.

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 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.

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.

Primary outcomes:
measure: Level of Skin Pigmentation
timeFrame: Day 1 of study participation
Secondary outcomes:
measure: Fitzpatrick Skin Tone Scale
timeFrame: Day 1 of study participation
measure: Monk Skin Tone Scale
timeFrame: Day 1 of study participation
measure: Number of participants who experience at least one episode of occult hypoxemia
timeFrame: Day 1 of study participation
Other outcomes:
Locations:
city: New York
country: United States
facility: Mount Sinai Hospital
state: New York
Study officials:
affiliation: Icahn School of Medicine at Mount Sinai
name: Garrett W. Burnett, M.D.
role: PRINCIPAL_INVESTIGATOR
References: