Non-Invasive Ventilation Preoperative Lung Resection Surgery

Study Overview
=================
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.

Official Title
-----------------
Evaluation of Non-Invasive Ventilation Preoperative Lung Resection Surgery

Conditions
-----------------
Surgery for Primary Lung Cancer

Intervention / Treatment
-----------------
* Device: Manufacturer (VPAP ST)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manufacturer VPAP ST<br>7 days minimum non-invasive ventilation at 2 levels of pressure (BPAP) to the intervention. | Device: Manufacturer (VPAP ST)<br>* non-invasive ventilation in two pressure levels 7 days before surgery<br>|
| No Intervention: No intervention<br>usual advice | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction of pulmonary complications and cardiovascular postoperative | 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. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identifying sub-groups of patients | Identify subgroups of patients benefiting most from a non-invasive ventilation preoperatively and safety of this technique preoperatively. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary lung cancer, lobectomy, pneumonectomy, non-invasive ventilation