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临床试验/NCT01630395
NCT01630395已完成不适用

The Effect of Recruitment Maneuver With Protective Ventilation on the Pulmonary and Systemic Inflammatory Response to One-lung Ventilation

Seoul National University Hospital1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2012年6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
60
试验地点
1
主要终点
Levels of IL-8, TNFa in the bronchoalveolar lavage

研究概览

简要总结

The purpose of this study is to determine if a recruitment maneuver combined with protective ventilatory strategy could reduce the pulmonary and systemic inflammatory responses to one-lung ventilation during thoracic surgery.

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
20 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •20 Years and older
  • •Patients undergoing thoracic surgery

排除标准

  • •Emergency surgery
  • •Heart failure
  • •Pulmonary hypertension
  • •Forced vital capacity or forced expiratory volume in 1 sec < 50% of the predicted values
  • •Coagulation disorder
  • •Pulmonary or extrapulmonary infections
  • •History of treatment with steroid in 3 months before surgery
  • •History of recurrent pneumothorax
  • •History of lung resection surgery

研究组 & 干预措施

conventional

No Intervention

Two-lung ventilation: tidal volume = 10 ml/kg, no PEEP. One-lung ventilation: tidal volume = 10 ml/kg, no PEEP

Protective

Active Comparator

Two-lung ventilation: tidal volume 8 ml/kg, PEEP of 5 cmH2O. One-lung ventilation: tidal volume 6 ml/kg, PEEP of 5 cmH2O.

干预措施: protective ventilation (Procedure)

Recruitment

Active Comparator

Two-lung ventilation: tidal volume 8 ml/kg, PEEP of 5 cmH2O. One-lung ventilation: tidal volume 6 ml/kg, PEEP of 5 cmH2O. Recruitment maneuver will be applied during one-lung ventilation.

干预措施: Recruitment maneuver combined with protective ventilation (Procedure)

结局指标

主要结局

Levels of IL-8, TNFa in the bronchoalveolar lavage

时间窗: up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery

次要结局

  • plasmatic concentration of inflammatory mediators IL-1, IL-6, IL-8, IL-10, TNFa(up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery)
  • oxygenation(1 hour after extubation)
  • Levels of IL-1, IL-6, IL-10 in the bronchoalveolar lavage(up to 20 minutes, after reexpansion of the non-dependent lung at the end of surgery)
  • Chest-X ray(7 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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