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临床试验/NCT03234621
NCT03234621已完成不适用

Protective Ventilation Strategy During One-lung Ventilation: Effect on Postoperative Pulmonary Complications

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 87 人开始时间: 2017年7月12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
87
试验地点
1
主要终点
postoperative pulmonary complications

研究概览

简要总结

The purpose of this study is to find a proper ventilation strategy for one-lung ventilation to prevent postoperative pulmonary complications

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Prevention
盲法
Double (Participant, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients undergoing elective thoracic surgery
  • ASA I, II, III
  • scheduled > 2 hours of surgery

排除标准

  • denied patients
  • age under 18 years
  • FEV1/FVC or FEV1<70% in preoperative pulmonary function test

研究组 & 干预措施

conventional tidal group

Experimental

provide tidal volume of 6ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation

干预措施: ventilator setting during one-lung ventilation (Other)

low tidal group

Experimental

provide tidal volume of 4ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation

干预措施: ventilator setting during one-lung ventilation (Other)

high tidal group

Experimental

provide tidal volume of 8ml/kg (predicted body weight) with positive end expiratory pressure of 5cmH2O during one-lung ventilation

干预措施: ventilator setting during one-lung ventilation (Other)

结局指标

主要结局

postoperative pulmonary complications

时间窗: immediately after operation

PaO2/FiO2 and/or newly appeared atelectasis, lung infiltration

次要结局

未报告次要终点

研究者

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

Jae-Hyon Bahk, MD, PhD

Professor

Seoul National University Hospital

研究点 (1)

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