Beyond Race: Objectively Assessed Skin Color and Its Association With Pulse Oximeter Bias in Critically Ill Infants

Study Overview
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Brief Summary
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The overall objective of this proposal is to quantify the bias in pulse oximeter reported oxygen saturation (SpO2) by evaluating its measures compared to the gold standard blood gas measured arterial oxygen saturation (SaO2) across race and skin pigmentation. The main question that the investigators intend to answer is whether There is greater pulse oximeter bias and subclinical hypoxemia in (1a) Black compared to White infants, and (1b) dark versus light-pigmented infants This bias increases with gestational and postnatal maturation This bias is associated with adverse patient outcomes

Detailed Description
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The study investigators will conduct a prospective observational study involving 200 infants (0-3 months age) and compare simultaneously obtained pulse oximeter readings (SpO2) and co-oximeter measured blood gas arterial oxygen saturation (SaO2), among infants identified as Non-Hispanic Black and Non-Hispanic White. The investigators will also obtain an objective assessment of skin pigmentation using a non-invasive device, SkinColorCatch® (by Delfin Technologies Ltd, Finland) that provides (1) a melanin index and (2) an objective six-point categorization of skin color based on Individual Typology Angle (ITA). Therefore, the investigators will measure the pulse oximeter bias (SpO2-SaO2) across infants identified as Non-Hispanic Black and Non-Hispanic White, as well as among infants of various skin pigmentation. For infants that have an arterial line for more than one week, the researchers will measure pulse oximeter bias (SpO2-SaO2) on a weekly basis over time with skin maturation and pigmentation changes.

Official Title
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Objectively Assessed Skin Color and Its Association With Pulse Oximeter Bias in Critically Ill Infants

Conditions
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Pulse Oximetry, Disparities, Infants

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed Informed Consent Postnatal age less than 3 months corrected age Presence of an in-dwelling umbilical or peripheral arterial line Gestational age >= 25 weeks Exclusion Criteria: Known skin pigmentary disorders Significantly impaired skin integrity Systemic bruising due to birth trauma Circulatory shock within last 48 hours Infants of peri-viable gestation (22-24 weeks)

Ages Eligible for Study
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Maximum Age: 3 Months

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Non-Hispanic Black<br>Infants born to mothers identifying as Non-Hispanic Black | |
| Non-Hispanic White<br>Infants born to mothers identifying as Non-Hispanic White | |
| Infants across the spectrum of melanin index and ITA-based skin color classification<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systematic Bias in pulse oximetry | The difference between the blood gas measured arterial oxygen saturation (SaO2) and pulse oximeter reported oxygen saturation (SpO2) | Within 5 seconds | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occult Hypoxemia | The prevalence of occult hypoxemia defined as pulse oximeter reported oxygen saturation (SpO2) of greater than 90% when blood gas measured arterial oxygen saturation (SaO2) is less than 88%. | Within 5 seconds | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pulse oximeter, bias, disparities, infants, premature