Evaluation of SpO2 Accuracy in Children With Various Skin Color
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- Nihon Kohden
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- SpO2 accuracy
研究概览
简要总结
Evaluation of SpO2 Accuracy in Children with Various Skin Color
详细描述
Pulse oximeters, which estimate blood oxygen levels, are routinely utilized for monitoring. However, research has shown that these devices may provide higher readings for individuals with darker skin tones as compared to individuals with lighter skin tones. This inaccuracy can result in unnoticed or untreated low oxygen levels, particularly affecting racial and ethnic minorities. It is beneficial for patients and healthcare providers to evaluate the accuracy of pulse oximeter oxygen saturation (SpO2) readings from pulse oximeters sold in the U.S. This study test the Nihon Kohden pulse oximeter and SpO2 sensors in neonatal and pediatric patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 0 Days 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children aged 0 - 12 who are admitted to the CICU with or plan to have an indwelling arterial line for standard care
排除标准
- •Patients with elevated levels of methemoglobin and carboxyhemoglobin, or anemia.
- •Patients with prolonged hypotension at the time of enrollment.
- •Patients with ductal-dependent congenital cardiac disease.
结局指标
主要结局
SpO2 accuracy
时间窗: 24 hours
Evaluate the accuracy of Nihon Kohden SpO2 in measuring blood oxygen levels in children with varying skin tones
次要结局
- SpO2 to SaO2 agreement(24 hours)