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

Arkansas Children's Hospital Research Institute

Status: Not yet enrolling

Conditions: Disparities; Infants; Pulse Oximetry

Study type: Observational

Funder types: Other

Identifiers

NCT05994417

275653

Details and patient eligibility

About

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

1. There is greater pulse oximeter bias and subclinical hypoxemia in (1a) Black compared to White infants, and (1b) dark versus light-pigmented infants
2. This bias increases with gestational and postnatal maturation
3. This bias is associated with adverse patient outcomes

Full description

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.

Enrollment: 200 estimated patients

Sex: All

Ages: Under 3 months old

Volunteers: No Healthy Volunteers

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)

Trial design

200 participants in 3 patient groups

Non-Hispanic Black

Description:

Infants born to mothers identifying as Non-Hispanic Black

Non-Hispanic White

Description:

Infants born to mothers identifying as Non-Hispanic White

Infants across the spectrum of melanin index and ITA-based skin color classification