Concomitant Tracheostomy and Lung Resection in Patient With Low Postoperative Pulmonary Function
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- number of mechanical ventilation days after operation until discharge
研究概览
简要总结
This protocol has been designed to determine if tracheostomy performed immediately after lung operation (i.e. concomitant tracheotomy) could improve the postoperative outcome of high risk patients. We hypothesized that concomitant tracheotomy could reduce the length of mechanical ventilation and the number of respiratory complications.
详细描述
Background: Respiratory failure after lung resection is a major complication. Several studies suggest that low predictive postoperative pulmonary function is a predictive factor of mechanical ventilation (MV). In critically ill patients requiring MV, early tracheostomy may shorten the duration of MV and length of stay in intensive care.
Study objective: To determine whether concomitant tracheostomy (CT) would decrease the length of MV and improves outcome in patient with predictive postoperative forced expiratory volume in 1 second (FEV1ppo) < 50%. We call CT a tracheostomy performed immediately after the lung resection under the same general anesthesia.
Method: An open monocentric randomized controlled trial has been design. Inclusion and exclusion criteria are mentioned below. FEV1ppo will be calculated by the mean of the scintigraphic method for pneumonectomy and by the mean of the number of resected segments for lobectomy and segmentectomy. Randomization will be made the day before the operation. The procedure will be an open surgical tracheostomy. A daily data base will be completed from randomization until discharge. The primary and secondary criteria are mentioned below.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age between 18 and 79 years old
- •preoperative diagnosis of suspected lung cancer
- •patient considered operable according to the guidelines
- •30% < postoperative predicted FEV1 < 50%
- •informed consent obtained by patient
排除标准
- •- age less than 18 and more than 79
- •pregnant woman
- •preoperative tracheostomy
- •postoperative vocal cord paralysis
- •postoperative diaphragmatic paralysis (except for pneumonectomy)
- •neuromuscular disorders
- •previous pharyngeal or laryngeal surgery
- •anatomical deformity of the neck making risky a tracheostomy
- •consent refusal
结局指标
主要结局
number of mechanical ventilation days after operation until discharge
时间窗: 2 months
次要结局
- 60 days mortality rate(2 months)
- ICU length of stay(2 months)
- hospital length of stay(2 months)
- cumulative incidence of postoperative respiratory complications defined as pneumonia, re-ventilation, atelectasis needing fiberbronchoscopy, non cardiogenic pulmonary edema, air leakage >7 days, broncho-pleural fistula, pulmonary embolism, empyema(2 months)
- cumulative incidence of postoperative cardiac complications defined as arrythmia needed treatment, cardiac failure needing inotrop drug, acute coronary stroke(2 months)
- general complications(2 months)
- laryngeal and tracheal complications(2 months)