Non-Invasive Ventilation Preoperative Lung Resection Surgery
Conditions
Surgery for Primary Lung Cancer
Conditions: Keywords
primary lung cancer, lobectomy, pneumonectomy, non-invasive ventilation
Study Type
Interventional
Study Phase
N/A
Study Design
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Intervention
Name: Manufacturer (VPAP ST)
Type: Device
Overall Status
Recruiting
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.
Criteria for eligibility
Healthy Volunteers: No
Maximum Age: N/A
Minimum Age: 18 Years
Gender: Both
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
Locations
Centre Hospitalier du Pays d'Aix
Aix en Provence, France
Status: Recruiting
Contact: Jacques Le Treut, PH
CHU Angers
Angers, France
Status: Not yet recruiting
Contact: Frédéric GAGNADOUX, Pr
Centre Hospitalier Victor Dupouy
Argenteuil, France
Status: Recruiting
Contact: Christine Donzel-Raynaud, PH
CHRU de Brest - Hôpital Morvan
Brest, France
Status: Recruiting
Contact: Francis COUTURAUD, PHD
Clinqiue du Grand Large
Brest, France
Status: Recruiting
Contact: Christophe LANCELIN, PH
Inter Army Hospital, Clermont-Tonnerre
Brest, France
Status: Recruiting
Contact: ANDRE Michel, MD
Inter Army Hospital
Clamart, France
Status: Recruiting
Contact: Jacques MARGERY, PHD
CHI Créteil
Créteil, France
Status: Recruiting
Contact: Christos CHOUAID, PHD
CHU Limoges
Limoges, France
Status: Recruiting
Contact: Thomas EGENOD, Dr
HIA Laveran
Marseille, France
Status: Terminated
Hospital, Pasteur
Nice, France
Status: Recruiting
Contact: Nicoals VENISSAC, PHD
Hôpital Pontchaillou
Rennes, France
Status: Recruiting
Contact: Hervé LENA, MD
CHG Roanne
Roanne, France
Status: Not yet recruiting
Contact: Valérie GRANGEON, Dr
CHU de Rouen
Rouen, France
Status: Recruiting
Contact: Antoine CUVELIER, MD
Inter Army Hospital, Saint-Anne
Toulon, France
Status: Recruiting
Contact: Henri BERARD, MD
Hôpital Nord Ouest Villefranche Sur Saône
Villefranche sur Saône, France
Status: Recruiting
Contact: Lionel FALCHERO, PH
Start Date
October 2012
Completion Date
February 2017
Sponsors
University Hospital, Brest
Source
University Hospital, Brest
Record processing date
ClinicalTrials.gov processed this data on July 28, 2015
ClinicalTrials.gov page