Evaluating the Relationship Between Skin Color and Pulse Oximeter Accuracy in Children
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 650
- 试验地点
- 3
- 主要终点
- Pulse Oximeter Bias
研究概览
简要总结
This multisite study seeks to understand whether and how pulse oximeter accuracy varies across children with different skin colors in real world clinical settings. Many factors can affect how well pulse oximeters work; for example, movement and even fingernail polish. Some studies in adults show that skin color may also affect the pulse oximeter reading. In this study, we will explore pulse oximeter accuracy in children of all skin colors who are undergoing cardiac catheterizations. The study will address limitations of prior work by objectively measuring skin color across multiple dimensions of color and comparing the the pulse oximeter reading to the "gold standard" blood sample measurement.
详细描述
This multisite, prospective, observational study will be conducted in a population of children under 18 years old who are undergoing cardiac catheterization. The primary aim of the study is to quantify pulse oximeter accuracy in children with varying skin colors. Children undergoing cardiac catheterization are a unique population in which to study pulse oximeter accuracy because they have a wide range of baseline arterial oxygen saturations secondary to their cardiac conditions, allowing for evaluation of pulse oximeter accuracy across a range of arterial oxygen saturations. Children undergoing cardiac catheterization are continuously monitored with pulse oximeters and also have direct measurement of arterial blood oxygen via co-oximeter as part of routine care. The results of this study will contribute much needed knowledge about pulse oximeter accuracy in children to better understand potential clinical implications.
Dimensions of skin colors (melanin index, redness etc) will be objectively measured using spectrophotometry. During and after the catheterization procedure, clinical data already collected during the course of clinical care will be recorded by the study team, including pulse oximeter output and arterial blood oxygen saturation measurement obtained during the procedure. The primary outcome of interest is the difference between the pulse oximeter reading and the direct measurement of arterial blood oxygen.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 4 Weeks 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Child is between 1 month and 18 years old
- •Child is undergoing a cardiac catheterization procedure that typically involves direct arterial oxygen saturation measurement by co-oximeter from a location reflective of systemic saturation.
排除标准
- •Child previously participated in the study
- •Child has differential cyanosis across extremities
- •Child is receiving an intravenous vasoconstrictor prior to procedure
- •Child has a ventricular assist device (VAD)
结局指标
主要结局
Pulse Oximeter Bias
时间窗: The variables used to calculate Pulse Oximeter Bias are collected once during the cardiac catheterization procedure. This is a cross-sectional observational study; participants are not followed longitudinally.
Pulse oximeter bias is the difference between the pulse oximeter value (estimated % oxygen saturation measured via pulse oximeter) and the gold standard measure of arterial oxygen saturation (% oxygen saturation in blood sample measured via co-oximeter).
次要结局
未报告次要终点