NCT02870842已完成不适用
Effects of Fraction of Inspired Oxygen on Atelectasis in Mechanically Ventilated Children
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 2
- 主要终点
- Incidence of postoperative atelectasis
研究概览
简要总结
Investigators hypothesized that maintaining low fraction of inspired oxygen would be beneficial to prevent anesthesia-induced atelectasis in mechanically ventilated children undergoing general anesthesia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- — 至 7 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Expected operation time between 1 to 3 hours under general anesthesia
- •Mechanically ventilated after endotracheal intubation
排除标准
- •Cardiac, thoracic, abdominal surgery
- •History of surgery on the lungs
- •Laparoscopic surgery
- •Abnormal preoperative chest radiograph findings including atelectasis, pneumothorax, pleural effusion, and pneumonia
- •Considered inappropriate by the investigator
结局指标
主要结局
Incidence of postoperative atelectasis
时间窗: within the first day after the surgery
次要结局
- Intraoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)(from the induction of general anesthesia until the end of the surgery, up to 4 hours)
- Postoperative incidence of respiratory complications(within the first day after the surgery)
- Postoperative incidence of fever (≥37.5℃)(within the first day after the surgery)
- Incidence of atelectasis after endotracheal intubation(from the moment of endotracheal intubation until the end of surgery, up to 4 hours)
- Postoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)(within the first day after the surgery)
研究者
Jin-Tae Kim
Associate professor
Seoul National University Hospital
研究点 (2)
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