Non-Invasive Ventilation Preoperative Lung Resection Surgery (préOVNI)

Regional University Hospital Center (CHRU)

Status

Completed

Conditions

Surgery for Primary Lung Cancer

Treatments

Device: Manufacturer (VPAP ST)

Study type

Interventional

Funder types

Other

Identifiers

NCT01685580

RB 11.095 préOVNI

Details and patient eligibility

About

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.

Enrollment

300 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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