Skin Pigment/Pulse Oximeter in Congenital Heart Disease (CHD)
- Conditions
- Skin PigmentCongenital Heart DiseaseHypoxemia
- Registration Number
- NCT06575270
- Lead Sponsor
- Icahn School of Medicine at Mount Sinai
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 92
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Level of Skin Pigmentation Day 1 of study participation Pulse oximeter accuracy as it relates to level of skin pigmentation as measured by color spectrophotometry. Pulse oximeter accuracy will be measured using the Accuracy Root Mean Squared (ARMS), mean bias, and proportional bias (Bland-Altman).
- Secondary Outcome Measures
Name Time Method Fitzpatrick Skin Tone Scale Day 1 of study participation Pulse Oximeter Accuracy in measuring skin pigmentation as measured by Fitzpatrick Skin Tone Scale Pulse oximeter accuracy as it relates to level of skin pigmentation as measured by Fitzpatrick Scale. Scale from I-VI, with higher number indicating darker skin tone
Number of participants who experience at least one episode of occult hypoxemia Day 1 of study participation Incidence of occult hypoxemia, defined as SpO2 ≥92% despite SaO2≤88%, as it relates to measured skin pigment and incidence of occult hypoxemia will be described. Incidence will be measured by assessing the total number of participants who experience at least one episode of occult hypoxemia.
Monk Skin Tone Scale Day 1 of study participation Pulse oximeter accuracy as it relates to level of skin pigmentation as measured by Monk Skin Tone Scale. Scale from 1-10, higher numbers indicates darker skin tone.
Trial Locations
- Locations (1)
Mount Sinai Hospital
🇺🇸New York, New York, United States