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
This trial does not accept healthy volunteersQualifiers
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 population
Pediatric patients with a past medical history of congenital heart disease presenting for cardiac surgery under general anesthesia with anticipated arterial vascular access.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
24 Participants
are grouped into 1 trial groupGroup A: Pediatric Patients with Congenital Heart Disease
Trial outcomes
Primary outcomes
1
Level of Skin Pigmentation
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).
Time frame
Day 1 of study participationSecondary outcomes
1
Fitzpatrick Skin Tone Scale
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
Time frame
Day 1 of study participation2
Monk Skin Tone Scale
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.
Time frame
Day 1 of study participation3
Number of participants who experience at least one episode of occult hypoxemia
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.
Time frame
Day 1 of study participationSponsors and contacts
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Source ClinicalTrials.gov