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临床试验/NCT02535013
NCT02535013已完成不适用

Benefit of Intraoperative Lung Ultrasound in Pediatric Patients Undergoing Cardiac Surgery

Seoul National University Hospital2 个研究点 分布在 1 个国家目标入组 122 人开始时间: 2015年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
122
试验地点
2
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

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

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

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jin-Tae Kim

Associate professor

Seoul National University Hospital

研究点 (2)

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