Non-Invasive Ventilation Preoperative Lung Resection Surgery (préOVNI)

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Hospital, Brest
Sponsor:
Collaborator:
Ministry of Health, France
Information provided by (Responsible Party):
University Hospital, Brest
ClinicalTrials.gov Identifier:
NCT01685580
First received: September 12, 2012
Last updated: March 31, 2014
Last verified: March 2014
  Purpose

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 Intervention
Surgery for Primary Lung Cancer
Device: Manufacturer (VPAP ST)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Evaluation of Non-Invasive Ventilation Preoperative Lung Resection Surgery

Resource links provided by NLM:


Further study details as provided by University Hospital, Brest:

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


Estimated Enrollment: 300
Study Start Date: October 2012
Estimated Study Completion Date: February 2015
Estimated Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01685580

Contacts
Contact: Nicolas PALEIRON, MD +33298437301 nicolas.paleiron@free.fr

Locations
France
Centre Hospitalier du Pays d'Aix Not yet recruiting
Aix en Provence, France, 13616
Contact: Jacques Le Treut, PH         
Principal Investigator: Jacques Le Treut, PH         
Sub-Investigator: André TOMESCOT, PH         
Centre Hospitalier Victor Dupouy Recruiting
Argenteuil, France, 95100
Contact: Christine Donzel-Raynaud, PH         
Principal Investigator: Christine Donzel-Raynaud, PH         
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         
Clinqiue du Grand Large Recruiting
Brest, France, 29200
Contact: Christophe LANCELIN, PH         
Principal Investigator: Christophe LANCELIN, MD         
Sub-Investigator: Yvonnick RAUT, MD         
Inter Army Hospital Recruiting
Clamart, France, 92141
Contact: Jacques MARGERY, PHD         
Principal Investigator: Jacques MARGERY, PHD         
HIA Laveran Not yet recruiting
Marseille, France, 13384
Contact: Claudia NATALE, MD         
Principal Investigator: Claudia NATALE, MD         
Hospital, Pasteur Recruiting
Nice, France, 06000
Contact: Nicoals VENISSAC, PHD         
Principal Investigator: Nicolas VENISSAC, PHD         
Sub-Investigator: Olivier AZE         
Saint-Antoine Hospital Not yet recruiting
Paris, France, 75012
Contact: Christos CHOUAID, PHD         
Principal Investigator: Christos CHOUAID, PHD         
Hôpital Pontchaillou Not yet recruiting
Rennes, France, 35033
Contact: Hervé LENA, MD         
Principal Investigator: Hervé LENA, MD         
Sub-Investigator: Romain CORRE, MD         
Sub-Investigator: Mallorie KERJOUAN, MD         
CHU de Rouen Not yet 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         
Inter Army Hospital, Saint-Antoine 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 Not yet 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
Investigators
Principal Investigator: Nicolas PALEIRON, MD Brest, Inter Army Hospital Clermont-Tonnerre
  More Information

No publications provided

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01685580     History of Changes
Other Study ID Numbers: RB 11.095 préOVNI
Study First Received: September 12, 2012
Last Updated: March 31, 2014
Health Authority: France : ANSM - Agence Nationale de Sécutité du Médicament et des produits de santé

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

Additional relevant MeSH terms:
Lung Neoplasms
Respiratory Tract Neoplasms
Thoracic Neoplasms
Neoplasms by Site
Neoplasms
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 23, 2014