Benefit of Intraoperative Lung Ultrasound in Pediatric Patients Undergoing Cardiac Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 122
- 试验地点
- 1
- 主要终点
- Postoperative incidence of SpO2 ≤ 95% (or 10% below the baseline value)
研究概览
简要总结
Investigators hypothesized that perioperative lung ultrasound would be beneficial in pediatric patients undergoing cardiac surgery compared to those who did not receive lung ultrasound.
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
- None
入排标准
- 年龄范围
- — 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Acyanotic congenital heart disease patients undergoing cardiac surgery under general anesthesia
排除标准
- •History of surgery on the lungs
- •Cyanotic congenital heart disease
- •Abnormal preoperative chest radiograph findings including atelectasis, pneumothorax, pleural effusion, and pneumonia
- •Considered inappropriate by the investigator
研究组 & 干预措施
Control
No intervention during the perioperative period. Perform lung ultrasound twice only for the diagnostic purpose at the end of surgery and 6 to 12 hours after surgery in the intensive care unit.
干预措施: Lung ultrasound (Device)
Ultrasound
Perform lung ultrasound three times during the perioperative period; after the induction of general anesthesia, at the end of surgery, and 6 to 12 hours after surgery in the intensive care unit. According to the lung ultrasound finding, conduct appropriate interventions such as, alveolar recruitment maneuver for atelectasis, or chest tube insertion for pneumothorax.
干预措施: Lung ultrasound (Device)
结局指标
主要结局
Postoperative incidence of SpO2 ≤ 95% (or 10% below the baseline value)
时间窗: within the first day after surgery
Intraoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)
时间窗: from the induction of general anesthesia until the end of the surgery, up to 24 hours
Postoperative incidence of respiratory complications
时间窗: within the first day after surgery
次要结局
- Postoperative partial pressure of oxygen in arterial blood (PaO2) from arterial blood gas analysis(within the first day after surgery)
- Intraoperative partial pressure of oxygen in arterial blood (PaO2) from arterial blood gas analysis(from the induction of general anesthesia until the end of the surgery, up to 24 hours)
- Initial SpO2 on arriving at pediatric intensive care unit(from the end of the surgery until postoperative 1 hour)
- Days needed to wean from mechanical ventilation(up to 1 month)
研究者
Jin-Tae Kim
Associate professor
Seoul National University Hospital