Surgery for Primary Lung Cancer
Conditions
Keywords
primary lung cancer, lobectomy, pneumonectomy, non-invasive ventilation
Brief summary
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.
Interventions
DEVICEManufacturer (VPAP ST)
non-invasive ventilation in two pressure levels 7 days before surgery
Sponsors
Ministry of Health, France
University Hospital, Brest
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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. AND * 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)
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of pulmonary complications and cardiovascular postoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Identifying sub-groups of patients | 1 month | Identify subgroups of patients benefiting most from a non-invasive ventilation preoperatively and safety of this technique preoperatively. |
Countries
France
Outcome results
None listed