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临床试验/NCT02584023
NCT02584023已完成不适用

Preventive Effect of Lung Ultrasound and Alveolar Recruitment on Atelectasis in Mechanically Ventilated Infants

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2015年10月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
40
试验地点
1
主要终点
Postoperative incidence of pulmonary atelectasis

研究概览

简要总结

Investigators hypothesized that lung ultrasound-assisted recruitment maneuver would be beneficial in mechanically ventilated infants compared to those who did not receive lung ultrasound and alveolar recruitment maneuver.

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
1 Day 至 1 Year(Child)
性别
All
接受健康志愿者
否

入选标准

  • •Minor surgery less than 2 hours under general anesthesia
  • •Mechanically ventilated after endotracheal intubation

排除标准

  • •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

Control

Placebo Comparator

No intervention during the perioperative period. Perform lung ultrasound twice only for the diagnostic purpose after the endotracheal intubation and and at the end of surgery.

干预措施: Lung ultrasound (Device)

Alveolar recruitment

Active Comparator

Perform lung ultrasound twice during the perioperative period after the endotracheal intubation and and at the end of surgery. Conduct alveolar recruitment maneuver after first lung ultrasound assessment.

干预措施: Lung ultrasound (Device)

结局指标

主要结局

Postoperative incidence of pulmonary atelectasis

时间窗: within the first day after the surgery

次要结局

  • Intraoperative incidence of pulmonary atelectasis after endotracheal intubation(from the moment of endotracheal intubation until the end of surgery, up to 6 hours)
  • 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 6 hours)
  • Postoperative incidence of pulse oximetry (SpO2) ≤ 95% (or 10% below the baseline value)(within the first day after the surgery)

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 (1)

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