Non-Invasive Ventilation Preoperative Lung Resection Surgery (préOVNI)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT01685580
Recruitment Status : Recruiting
First Posted : September 14, 2012
Last Update Posted : January 16, 2017
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest

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.

Condition or disease Intervention/treatment Phase
Surgery for Primary Lung Cancer Device: Manufacturer (VPAP ST) Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Evaluation of Non-Invasive Ventilation Preoperative Lung Resection Surgery
Study Start Date : October 2012
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Manufacturer VPAP ST
7 days minimum non-invasive ventilation at 2 levels of pressure (BPAP) to the intervention.
Device: Manufacturer (VPAP ST)
non-invasive ventilation in two pressure levels 7 days before surgery

No Intervention: No intervention
usual advice

Primary Outcome Measures :
  1. Reduction of pulmonary complications and cardiovascular postoperative [ Time Frame: 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 Outcome Measures :
  1. Identifying sub-groups of patients [ Time Frame: 1 month ]
    Identify subgroups of patients benefiting most from a non-invasive ventilation preoperatively and safety of this technique preoperatively.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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.


  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01685580

Contact: Nicolas PALEIRON, MD +33298437301

Centre Hospitalier du Pays d'Aix Recruiting
Aix en Provence, France, 13616
Contact: Jacques Le Treut, PH         
Principal Investigator: Jacques Le Treut, PH         
Sub-Investigator: André TOMESCOT, PH         
CHU Angers Recruiting
Angers, France, 49933
Contact: Frédéric GAGNADOUX, Pr         
Principal Investigator: Frédéric GAGNADOUX, Pr         
Sub-Investigator: Wojciech TRZEPIZUR, Dr         
Centre Hospitalier Victor Dupouy Recruiting
Argenteuil, France, 95100
Contact: Christine Donzel-Raynaud, PH         
Principal Investigator: Christine Donzel-Raynaud, PH         
Clinqiue du Grand Large Recruiting
Brest, France, 29200
Contact: Christophe LANCELIN, PH         
Principal Investigator: Christophe LANCELIN, MD         
Sub-Investigator: Yvonnick RAUT, MD         
CHRU de Brest - Hôpital Morvan Recruiting
Brest, France, 29609
Contact: Francis COUTURAUD, PHD         
Sub-Investigator: Nicolas PALEIRON, MD         
Sub-Investigator: Christophe GUT-GOBERT, MD         
Sub-Investigator: Aude BARNIER, MD         
Sub-Investigator: Gilles ROBINET, MD         
Sub-Investigator: Gilles QUERE, MD         
Sub-Investigator: Renaud DESCOURT, MD         
Sub-Investigator: Sylvie GOUVA, MD         
Sub-Investigator: Cyrille EVEILLEAU, MD         
Sub-Investigator: Catherine GUENNEGAN, MD         
Sub-Investigator: Michelle COAT, MD         
Sub-Investigator: Thierry NIMAL, MD         
Sub-Investigator: Ronan DEMEDEC, MD         
Sub-Investigator: Sylvie AIRIAU, MD         
Sub-Investigator: Jacques PIETRI, MD         
Sub-Investigator: Jean-Ferréol OILLEAU, MD         
Sub-Investigator: Elise NOEL-SAVINA, MD         
Principal Investigator: Francis COUTURAUD, PU-PH         
Inter Army Hospital, Clermont-Tonnerre Recruiting
Brest, France, 29609
Contact: ANDRE Michel, MD         
Sub-Investigator: Frédéric GRASSIN, MD         
Sub-Investigator: Ulric VINSONNEAU, MD         
Sub-Investigator: Sandrine EYRIEUX, MD         
Sub-Investigator: Nicolas PALEIRON, MD         
Principal Investigator: Michel ANDRE, MD         
Inter Army Hospital Recruiting
Clamart, France, 92141
Contact: Jacques MARGERY, PHD         
Principal Investigator: Jacques MARGERY, PHD         
CHI Créteil Recruiting
Créteil, France, 94010
Contact: Christos CHOUAID, PHD         
Principal Investigator: Christos CHOUAID, PHD         
CHU Limoges Recruiting
Limoges, France, 87042
Contact: Thomas EGENOD, Dr         
Principal Investigator: Thomas EGENOD, Dr         
HIA Laveran Withdrawn
Marseille, France, 13384
Hospital, Pasteur Recruiting
Nice, France, 06000
Contact: Nicoals VENISSAC, PHD         
Principal Investigator: Nicolas VENISSAC, PHD         
Sub-Investigator: Olivier AZE         
Hôpital Pontchaillou Terminated
Rennes, France, 35033
CHG Roanne Withdrawn
Roanne, France, 42300
CHU de Rouen Recruiting
Rouen, France, 76031
Contact: Antoine CUVELIER, MD         
Principal Investigator: Antoine CUVELIER, MD         
Sub-Investigator: Jean-François MUR, PH         
Sub-Investigator: Dominique LEGENTIL, MD         
Sub-Investigator: Suzanna BOTA, MD         
CHU Saint-Etienne Recruiting
Saint-Etienne, France, 42055
Contact: Olivier TIFFET, Dr         
Inter Army Hospital, Saint-Anne Recruiting
Toulon, France, 83041
Contact: Henri BERARD, MD         
Principal Investigator: Henri BERARD, MD         
Sub-Investigator: Julien LEGODEC, MD         
Sub-Investigator: Jean-Baptiste ROSEAU, MD         
Sub-Investigator: Thierry NGUYEN HUY THUY, MD         
Hôpital Nord Ouest Villefranche Sur Saône Recruiting
Villefranche sur Saône, France, 69655
Contact: Lionel FALCHERO, PH         
Principal Investigator: Lionel FALCHERO, PH         
Sub-Investigator: Luc Odier, PH         
Sub-Investigator: Sonia Blandin, PH         
Sub-Investigator: Christine Dussopt, PH         
Sponsors and Collaborators
University Hospital, Brest
Ministry of Health, France
Principal Investigator: Nicolas PALEIRON, MD Brest, Inter Army Hospital Clermont-Tonnerre

Responsible Party: University Hospital, Brest Identifier: NCT01685580     History of Changes
Other Study ID Numbers: RB 11.095 préOVNI
First Posted: September 14, 2012    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017

Keywords provided by University Hospital, Brest:
primary lung cancer
non-invasive ventilation