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
- To characterize mechanical ventilation practices during general anesthesia for surgery
- 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
- 否
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
研究点 (19)
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