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

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Disparities; Pulse Oximetry; Infants

Detailed 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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Megha Sharma, MD MS; Phone Number: 501-364-1028; Email: msharma@uams.edu
• Study Contact Backup: Name: Dannis Armikarina, BSN, RN; Phone Number: 501-296-1389; Email: ArmikarinaDL@archildrens.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

All preterm (i.e. infant less than 37 weeks gestation) and term infants (i.e. infants >= 37 weeks gestation) that have an indwelling arterial line and are admitted to the ACH neonatal intensive care unit (NICU) and cardiovascular intensive care unit (CVICU).

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Non-Hispanic Black; Infants born to mothers identifying as Non-Hispanic Black
Non-Hispanic White; Infants born to mothers identifying as Non-Hispanic White
Infants across the spectrum of melanin index and ITA-based skin color classification

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Arkansas Children's Hospital Research Institute

Study record dates

Study Major Dates

• Study Start (Estimated): August 15, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 9, 2023
• First Submitted That Met QC Criteria: August 15, 2023
• First Posted (Actual): August 16, 2023

Study Record Updates

• Last Update Posted (Actual): August 16, 2023
• Last Update Submitted That Met QC Criteria: August 15, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: infants; premature; bias; disparities; pulse oximeter
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: 275653

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No