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

Infants Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05994417
• Other study ID #: 275653
• Status: Not yet recruiting
• Start date: August 15, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: August 2023
• Source: Arkansas Children's Hospital Research Institute
• Contact: Megha Sharma, MD MS
• Phone: 501-364-1028
• Email: msharma[@]uams.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 3 Months

Eligibility

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)

Related Conditions & MeSH terms

• Critical Illness
• Disparities
• Infants
• Pulse Oximetry

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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