Status:
UNKNOWN
Beyond Race: Objectively Assessed Skin Color and Its Association With Pulse Oximeter Bias in Critically Ill Infants
Lead Sponsor:
Arkansas Children's Hospital Research Institute
Conditions:
Pulse Oximetry
Disparities
Eligibility:
All Genders
Up to 3 years
Brief 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 ...
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 measure...
Eligibility Criteria
Inclusion
- 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
- 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)
Key Trial Info
Start Date :
August 15 2023
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT05994417
Start Date
August 15 2023
End Date
December 31 2025
Last Update
August 16 2023
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