Evaluation of Non-Invasive Ventilation Preoperative Lung Resection Surgery
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 300
- 试验地点
- 30
- 主要终点
- Reduction of pulmonary complications and cardiovascular postoperative
研究概览
简要总结
Surgical treatment is the standard treatment for localized forms of lung cancer non-small cell. It allows a 5-year survival exceeding 50% for complete resection of the tumor. This is a heavy treatment, resulting in a mortality of 4 to 8% and a morbidity of 20-60%. Securing this procedure is a major public health issue. The non-invasive ventilation is a technique commonly used postoperatively in acute respiratory distress and in the treatment of sleep apnea syndromes. Through its effect on oxygenation and pulmonary function parameters, the non-invasive ventilation achieved during 7 days minimum before the intervention could significantly reduce postoperative complications in patients with an obstructive or restrictive disorder, obesity or chronic heart failure.
The aim of the study is to demonstrate that the non-invasive ventilation in two pressure levels achieved during at least 7 days before surgery lung resection (lobectomy or segmentectomy) halved the pulmonary and cardiovascular postoperative patients with obstructive ventilatory disorder or restrictive, obesity or chronic heart failure.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient over 18 years, to benefit from surgery scheduled for lung resection (lobectomy or segmentectomy) for primary lung cancer and having signed an informed consent.
- •Trouble obstructive (FEV / FVC <70% and FEV <80% predicted)
- •Or restrictive (FVC <80% or TLC <80%)
- •Or decrease in the ratio TLCO / VA <60%
- •Or history of respiratory failure with hypercapnic Pa CO2> 45 mmHg in the year preceding surgery
- •Or long-term oxygen
- •Or heart failure (clinical signs of heart failure and LVEF <55% or disorder of relaxation on echocardiography or atrial fibrillation)
- •Or history of acute cardiogenic pulmonary edema.
- •Or obesity (BMI> 30 kg/m2)
排除标准
- •Inability to consent
- •Patient declared inoperable given the comorbidities or refusing surgery or with unresectable tumors.
- •Patient operable but with no comorbidities described in the inclusion criteria
- •Contraindications to the non-invasive ventilation:
- •Lack of understanding of the technical
- •facial malformation
- •Tight stenosis of the upper airway
- •uncontrollable vomiting
- •Unable to remove the mask
- •Cognitive impairment or severe psychiatric jeopardizing the observance of the NAV
- •Patient non-insured
- •Patient already on invasive ventilation or non-invasive
- •During Pregnancy
研究组 & 干预措施
Manufacturer VPAP ST
7 days minimum non-invasive ventilation at 2 levels of pressure (BPAP) to the intervention.
干预措施: Manufacturer (VPAP ST) (Device)
No intervention
usual advice
结局指标
主要结局
Reduction of pulmonary complications and cardiovascular postoperative
时间窗: 1 month
Demonstrate that the non-invasive ventilation in two pressure levels achieved during at least 7 days before surgery lung resection (lobectomy or segmentectomy) halved the pulmonary and cardiovascular postoperative patients with obstructive ventilatory disorder or restrictive, obesity or chronic heart failure.
次要结局
- Identifying sub-groups of patients(1 month)