Evaluation of the Impact of a Narrower SpO2 Target Range on Performance of an Automatic FiO2 Control System: a Randomized Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 2
- 主要终点
- Percent time in the set SpO2 target range
研究概览
简要总结
The aim of the study is to determine if a narrower SpO2 Target Range setting automated control of FiO2 (A-FiO2) is more effective than a wider SpO2 Target Range
详细描述
A-FiO2 systems have consistently proven to be more effective than manual control. Because it is more precise than manual control, studies of some A-FiO2 systems found small differences in the set target range (shift in the median and width) can optimize the relative performance. Similar studies of the A-FiO2 system (PRICO) used in the investigator's NICU have not been conducted.
The standard of practice in the investigator's NICU is to use 4 different target ranges to balance the risk of hypoxia and hyperoxia based on the gestational age vulnerabilities. Based on the studies of other A-FiO2 systems the investigators believe a slightly narrower width target range would be more effective. Therefore, a small systematic study is needed to determine the optimal set target range to achieve the therapeutic goal.
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
- 年龄范围
- 2 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All VLBW on respiratory support and oxygen requirements after 2 weeks of age in the NICU are eligible after informed consent is obtained.
排除标准
- •Informed consent is not obtained
- •Recording device for automated control of FiO2 is not available
研究组 & 干预措施
Standard Target Range
The SpO2 TR width is set to 5% SpO2, as is routine in the department. The actual TR will vary depending on the GA, as is standard practice in the department.
Narrow Target Range
The SpO2 TR width is set narrower than the Standard TR. The actual TR will vary depending on the GA, as is standard practice in the department.
干预措施: Narrow TR (Device)
Shifted Target Range
The SpO2 TR width is set as the Standard TR. The median of the TR is shifted up compared to the Standard TR. The actual TR will vary depending on the GA, as is standard practice in the department.
干预措施: Shifted TR (Device)
结局指标
主要结局
Percent time in the set SpO2 target range
时间窗: 30 days of intervention if possible
Percent time in the set SpO2 target range (compliance). Periods with SpO2 higher than the target range with FiO2 = 0.21 will be included in the target range compliance.
Percent time at SpO2 ≤80% and >98%
时间窗: 30 days of intervention if possible
Percent time at SpO2 ≤80% and \>98% (safety). Periods with SpO2 higher than 98% with FiO2 = 0.21 will be excluded.
次要结局
- Percent time below the set SpO2 target range(30 days of intervention if possible)
- Percent time above the set SpO2 target range(30 days of intervention if possible)