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Non-Invasive Ventilation Preoperative Lung Resection Surgery (préOVNI)

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ClinicalTrials.gov Identifier: NCT01685580
Recruitment Status : Completed
First Posted : September 14, 2012
Last Update Posted : October 1, 2018
Sponsor:
Collaborator:
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)
Actual 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
Actual Study Start Date : October 8, 2012
Actual Primary Completion Date : October 25, 2017
Actual Study Completion Date : October 25, 2017

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
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

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 ClinicalTrials.gov identifier (NCT number): NCT01685580


Locations
France
Centre Hospitalier du Pays d'Aix
Aix en Provence, France, 13616
CHU Angers
Angers, France, 49933
Centre Hospitalier Victor Dupouy
Argenteuil, France, 95100
Clinqiue du Grand Large
Brest, France, 29200
CHRU de Brest - Hôpital Morvan
Brest, France, 29609
Inter Army Hospital, Clermont-Tonnerre
Brest, France, 29609
Inter Army Hospital
Clamart, France, 92141
CHI Créteil
Créteil, France, 94010
CHU Limoges
Limoges, France, 87042
Hospital, Pasteur
Nice, France, 06000
Hôpital Pontchaillou
Rennes, France, 35033
CHU de Rouen
Rouen, France, 76031
CHU Saint-Etienne
Saint-Etienne, France, 42055
Inter Army Hospital, Saint-Anne
Toulon, France, 83041
Hôpital Nord Ouest Villefranche Sur Saône
Villefranche sur Saône, France, 69655
Sponsors and Collaborators
University Hospital, Brest
Ministry of Health, France
Investigators
Principal Investigator: Nicolas PALEIRON, MD Brest, Inter Army Hospital Clermont-Tonnerre

Responsible Party: University Hospital, Brest
ClinicalTrials.gov Identifier: NCT01685580     History of Changes
Other Study ID Numbers: RB 11.095 préOVNI
First Posted: September 14, 2012    Key Record Dates
Last Update Posted: October 1, 2018
Last Verified: September 2018

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