Infants Clinical Trial
Official title:
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
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) |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
Arkansas Children's Hospital Research Institute |
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 |
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