Effects of Fraction of Inspired Oxygen on Atelectasis in Mechanically Ventilated Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 1
- 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
研究组 & 干预措施
Low FiO2
Perform recruitment maneuver with low FiO2 of 0.3 after intubation under lung ultrasound guidance and maintain FiO2 of 0.3 during the general anesthesia.
干预措施: Respiratory management (Other)
Control
Perform recruitment maneuver with fraction of inspired oxygen (FiO2) of 1.0 after intubation under lung ultrasound guidance and maintain FiO2 of 0.6 during the general anesthesia.
干预措施: Lung ultrasound (Device)
Control
Perform recruitment maneuver with fraction of inspired oxygen (FiO2) of 1.0 after intubation under lung ultrasound guidance and maintain FiO2 of 0.6 during the general anesthesia.
干预措施: Respiratory management (Other)
Low FiO2
Perform recruitment maneuver with low FiO2 of 0.3 after intubation under lung ultrasound guidance and maintain FiO2 of 0.3 during the general anesthesia.
干预措施: Lung ultrasound (Device)
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