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Non-Invasive Ventilation Preoperative Lung Resection Surgery (préOVNI)

Primary Purpose

Surgery for Primary Lung Cancer

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Manufacturer (VPAP ST)
Sponsored by
University Hospital, Brest
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Surgery for Primary Lung Cancer focused on measuring primary lung cancer, lobectomy, pneumonectomy, non-invasive ventilation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre Hospitalier du Pays d'Aix
  • CHU Angers
  • Centre Hospitalier Victor Dupouy
  • Clinqiue du Grand Large
  • CHRU de Brest - Hôpital Morvan
  • Inter Army Hospital, Clermont-Tonnerre
  • Inter Army Hospital
  • CHI Créteil
  • CHU Limoges
  • Hospital, Pasteur
  • Hôpital Pontchaillou
  • CHU de Rouen
  • CHU Saint-Etienne
  • Inter Army Hospital, Saint-Anne
  • Hôpital Nord Ouest Villefranche Sur Saône

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Manufacturer VPAP ST

No intervention

Arm Description

7 days minimum non-invasive ventilation at 2 levels of pressure (BPAP) to the intervention.

usual advice

Outcomes

Primary Outcome Measures

Reduction of pulmonary complications and cardiovascular postoperative
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
Identify subgroups of patients benefiting most from a non-invasive ventilation preoperatively and safety of this technique preoperatively.

Full Information

First Posted
September 12, 2012
Last Updated
September 28, 2018
Sponsor
University Hospital, Brest
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT01685580
Brief Title
Non-Invasive Ventilation Preoperative Lung Resection Surgery
Acronym
préOVNI
Official Title
Evaluation of Non-Invasive Ventilation Preoperative Lung Resection Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Completed
Study Start Date
October 8, 2012 (Actual)
Primary Completion Date
October 25, 2017 (Actual)
Study Completion Date
October 25, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Brest
Collaborators
Ministry of Health, France

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Surgery for Primary Lung Cancer
Keywords
primary lung cancer, lobectomy, pneumonectomy, non-invasive ventilation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Manufacturer VPAP ST
Arm Type
Experimental
Arm Description
7 days minimum non-invasive ventilation at 2 levels of pressure (BPAP) to the intervention.
Arm Title
No intervention
Arm Type
No Intervention
Arm Description
usual advice
Intervention Type
Device
Intervention Name(s)
Manufacturer (VPAP ST)
Intervention Description
non-invasive ventilation in two pressure levels 7 days before surgery
Primary Outcome Measure Information:
Title
Reduction of pulmonary complications and cardiovascular postoperative
Description
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.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Identifying sub-groups of patients
Description
Identify subgroups of patients benefiting most from a non-invasive ventilation preoperatively and safety of this technique preoperatively.
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicolas PALEIRON, MD
Organizational Affiliation
Brest, Inter Army Hospital Clermont-Tonnerre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre Hospitalier du Pays d'Aix
City
Aix en Provence
ZIP/Postal Code
13616
Country
France
Facility Name
CHU Angers
City
Angers
ZIP/Postal Code
49933
Country
France
Facility Name
Centre Hospitalier Victor Dupouy
City
Argenteuil
ZIP/Postal Code
95100
Country
France
Facility Name
Clinqiue du Grand Large
City
Brest
ZIP/Postal Code
29200
Country
France
Facility Name
CHRU de Brest - Hôpital Morvan
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Inter Army Hospital, Clermont-Tonnerre
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Inter Army Hospital
City
Clamart
ZIP/Postal Code
92141
Country
France
Facility Name
CHI Créteil
City
Créteil
ZIP/Postal Code
94010
Country
France
Facility Name
CHU Limoges
City
Limoges
ZIP/Postal Code
87042
Country
France
Facility Name
Hospital, Pasteur
City
Nice
ZIP/Postal Code
06000
Country
France
Facility Name
Hôpital Pontchaillou
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU de Rouen
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHU Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France
Facility Name
Inter Army Hospital, Saint-Anne
City
Toulon
ZIP/Postal Code
83041
Country
France
Facility Name
Hôpital Nord Ouest Villefranche Sur Saône
City
Villefranche sur Saône
ZIP/Postal Code
69655
Country
France

12. IPD Sharing Statement

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Non-Invasive Ventilation Preoperative Lung Resection Surgery

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