Clinical trial NCT01685580: Non-Invasive Ventilation Preoperative Lung Resection Surgery
Official title: Evaluation of Non-Invasive Ventilation Preoperative Lung Resection Surgery
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Surgery for Primary Lung Cancer
Keywords: primary lung cancer
lobectomy
pneumonectomy
non-invasive ventilation
Lead sponsor: University Hospital, Brest
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2012-09-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Reduction of pulmonary complications and cardiovascular postoperative
timeFrame: 1 month
Secondary outcomes:
measure: Identifying sub-groups of patients
timeFrame: 1 month
Other outcomes:
Locations:
city: Aix en Provence
country: France
facility: Centre Hospitalier du Pays d'Aix
city: Angers
country: France
facility: CHU Angers
city: Argenteuil
country: France
facility: Centre Hospitalier Victor Dupouy
city: Brest
country: France
facility: Clinqiue du Grand Large
city: Brest
country: France
facility: CHRU de Brest - Hôpital Morvan
city: Brest
country: France
facility: Inter Army Hospital, Clermont-Tonnerre
city: Clamart
country: France
facility: Inter Army Hospital
city: Créteil
country: France
facility: CHI Créteil
city: Limoges
country: France
facility: CHU Limoges
city: Nice
country: France
facility: Hospital, Pasteur
city: Rennes
country: France
facility: Hôpital Pontchaillou
city: Rouen
country: France
facility: CHU de Rouen
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
city: Toulon
country: France
facility: Inter Army Hospital, Saint-Anne
city: Villefranche sur Saône
country: France
facility: Hôpital Nord Ouest Villefranche Sur Saône
Study officials:
affiliation: Brest, Inter Army Hospital Clermont-Tonnerre
name: Nicolas PALEIRON, MD
role: PRINCIPAL_INVESTIGATOR
References: