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临床试验/NCT00805077
NCT00805077已完成不适用

Pulmonary Surgery and Protective Mechanical Ventilation

Assistance Publique - Hôpitaux de Paris1 个研究点 分布在 1 个国家目标入组 347 人开始时间: 2008年12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
347
试验地点
1
主要终点
Major postoperative complications during the first 30 days after surgery

研究概览

简要总结

The purpose of this trial is to evaluate the efficacy and the safety of lung protective ventilation during anesthesia in patients undergoing pneumonectomy or lobectomy for lung cancer.

详细描述

Extended description of the protocol could be provided by the URC-EST, SAINT ANTOINE HOSPITAL, University of Paris-VI and by principal investigator.

Pneumonectomy or lobectomy is associated with a high risk for postoperative complication. The benefit of lung protective ventilation with low tidal volume has been demonstrated in patients with acute respiratory distress syndrome (ARDS) and acute lung injury (ALI). Recent clinical studies have suggested that mechanical ventilation with low tidal volume may also profit in others setting. Lung protective ventilation during anaesthesia has been found to limit the inflammatory response in the lung and to decrease postoperative systemic inflammatory response. However, others trials did not found benefit of protective ventilation strategy during anaesthesia.

This study will be a randomized, controlled, doubled blind trial comparing two management ventilator strategies during anaesthesia for thoracotomy. Only patients undergoing pneumonectomy or lobectomy for lung primitive cancer will be included in this trial. During anesthesia, one group will receive mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP and the other will receive tidal volume of 10 ml/kg of ideal body weight without PEEP. After surgery, data concerning oxygen delivery, blood analysis, complications, cancer recurrence and death will be collected.

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, Investigator)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者
否

入选标准

  • •Primary lung cancer.
  • •Elective Pneumonectomy or lobectomy or bilobectomy
  • •Written informed consent

排除标准

  • •Patients undergoing surgical procedure other than pneumonectomy or lobectomy or bilobectomy
  • •Mesothelioma
  • •Liver cirrhosis
  • •Chronic renal failure
  • •Need for mechanical ventilation or non invasive ventilation (CPAP for obstructive sleep apnea syndrome for example) before surgery
  • •Emergency surgery

研究组 & 干预措施

1

Experimental

mechanical ventilation with low tidal volume (5 ml/kg of ideal body weight) plus PEEP

干预措施: mechanical ventilation (Procedure)

2

Other

tidal volume of 10 ml/kg of ideal body weight without PEEP

干预措施: tidal volume (Other)

结局指标

主要结局

Major postoperative complications during the first 30 days after surgery

时间窗: the first 30 days after surgery

次要结局

  • Minor postoperative complications during the first 30 days after surgery, length of stay in ICU and hospital, cancer recurrence, death(during the first 30 days after surgery)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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