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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
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| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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).
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Megha Sharma, MD MS | Contact | 501-364-1028 | msharma@uams.edu | |
| Dannis Armikarina, BSN, RN | Contact | 501-296-1389 | ArmikarinaDL@archildrens.org |
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| ID | Term |
|---|---|
| D047928 | Premature Birth |
| ID | Term |
|---|---|
| D007752 | Obstetric Labor, Premature |
| D007744 | Obstetric Labor Complications |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
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Arterial blood collected for routine clinical analysis of blood gas status
| D000091642 | Urogenital Diseases |