Objectively Assessed Skin Color and Its Association With Pulse Oximeter Bias in Critically Ill Infants
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 200
- 主要终点
- Systematic Bias in pulse oximetry
研究概览
简要总结
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
- There is greater pulse oximeter bias and subclinical hypoxemia in (1a) Black compared to White infants, and (1b) dark versus light-pigmented infants
- This bias increases with gestational and postnatal maturation
- This bias is associated with adverse patient outcomes
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 3 Months（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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)
结局指标
主要结局
Systematic Bias in pulse oximetry
时间窗: Within 5 seconds
The difference between the blood gas measured arterial oxygen saturation (SaO2) and pulse oximeter reported oxygen saturation (SpO2)
次要结局
- Occult Hypoxemia(Within 5 seconds)
研究者
Megha Sharma
Assistant Professor, Section of Neonatology, Department of Pediatrics, University of Arkansas for Medical Sciences, Arkansas Children's Hospital
Arkansas Children's Hospital Research Institute