Comparison of the IntellO2 - Precision Flow Automatic FiO2 Controller to Manual Control for Optimizing Oxygenation in Preterm Infants Receiving High Flow Nasal Cannula Therapy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 36
- 试验地点
- 2
- 主要终点
- Percent time in target range for oxygen saturation by pulse oximetry
研究概览
简要总结
The overall objective of this study is to demonstrate that the IntellO2 device providing automated control of fraction of inspired oxygen (FiO2) adjustments in spontaneously breathing infants with fluctuating arterial blood oxygen saturation levels is safe and efficacious in the routine clinical environment. Specifically, it is hypothesized that the IntellO2 will perform as well or better than standard practice for maintaining infants' arterial blood oxygen saturation in a target range while minimizing the exposure to elevated levels of oxygen in the inspired gas.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Preterm infants being treated with high flow nasal cannula therapy
- •A need for supplemental oxygen as demonstrated by an required FiO2 > 0.25 at enrollment
- •Requiring a flow rate of greater than 2 L/min such that the assumed inspired oxygen fraction matched delivered oxygen fraction (definition of HFNC).
排除标准
- •Major congenital abnormalities
- •Hemodynamic instability, defined as being outside of a normotensive range based on each infant's individual characteristics
- •Ongoing sepsis
- •Clinician's concern regarding stability of the infant
研究组 & 干预措施
IntellO2
Automated control of FiO2
干预措施: IntellO2 (Device)
Manual
Manual control of FiO2
干预措施: Manual control (Other)
结局指标
主要结局
Percent time in target range for oxygen saturation by pulse oximetry
时间窗: 24 hrs
次要结局
未报告次要终点