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临床试验/NCT01601223
NCT01601223已完成不适用

Local Assessment of Ventilatory Management During General Anesthesia for Surgery - a Prospective Observational Multi-center Cohort Study

European Society of Anaesthesiology19 个研究点 分布在 8 个国家目标入组 10,690 人开始时间: 2013年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
10,690
试验地点
19
主要终点
Post-operative pulmonary complications, possibly related to ventilation strategy

研究概览

简要总结

Objectives

  1. To characterize mechanical ventilation practices during general anesthesia for surgery
  2. To assess the dependence of intra-operative and post-operative pulmonary complications on intra-operative Mechanical Ventilation (MV) settings

详细描述

Research questions

  • What MV-settings are used during general anesthesia for surgery?
  • Do MV-settings vary in and/or between centers?
  • Do MV-settings vary internationally?
  • Are MV-settings associated with incidence of intra-operative pulmonary complications?
  • Are MV-settings associated with incidence of post-operative pulmonary complications?

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

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

入选标准

  • Age ≥ 18 years
  • All surgical procedures requiring invasive mechanical ventilation (MV)during general anesthesia for laparoscopic or non-laparoscopic surgery.
  • This includes MV performed with supra-glottic devices (e.g. laryngeal mask)
  • This includes patients receiving MV at the onset of the procedure (e.g. Intensive Care Unit patients)
  • This includes patients who will receive one-lung ventilation during the procedure

排除标准

  • Obstetric surgical procedures or any procedure during pregnancy
  • Surgical procedures outside the operating room
  • Surgical procedures involving extra-corporal circulation

结局指标

主要结局

Post-operative pulmonary complications, possibly related to ventilation strategy

时间窗: Post-operative on day of surgery, day 1, 2,3,4,5 and day 28

Effect of Mechanical Ventilation settings during general anesthesia for surgery on the incidence of post-operative pulmonary complications (new or prolonged invasive or non-invasive mechanical ventilation, need for oxygen therapy, respiratory failure, pneumonia, ARDS 'Acute Respiratory Distress Syndrome', pneumothorax) Defined post-operative pulmonary complications are recorded from the medical chart on day 0, 1, 2, 3, 4 and 5 after surgery. On day 28 length of hospital stay and in hospital death are assessed.

次要结局

  • Mechanical ventilation-settings during general anesthesia for surgery(During the surgical procedure, from moment of to tracheal extubation or discharge from operation room (in case patient remains on mechanical ventilation))
  • Intra-operative complications related to the ventilation strategy(Time point(s) at which outcome measure is assessed is is: Day of surgery, day 1, 2, 3, 4, 5 and 28 after surgery)

研究者

发起方
European Society of Anaesthesiology
申办方类型
Other
责任方
Sponsor

研究点 (19)

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