<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01685580</url>
  </required_header>
  <id_info>
    <org_study_id>RB 11.095 préOVNI</org_study_id>
    <nct_id>NCT01685580</nct_id>
  </id_info>
  <brief_title>Non-Invasive Ventilation Preoperative Lung Resection Surgery</brief_title>
  <acronym>préOVNI</acronym>
  <official_title>Evaluation of Non-Invasive Ventilation Preoperative Lung Resection Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Ministry of Health, France</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Brest</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Surgical treatment is the standard treatment for localized forms of lung cancer non-small&#xD;
      cell. It allows a 5-year survival exceeding 50% for complete resection of the tumor. This is&#xD;
      a heavy treatment, resulting in a mortality of 4 to 8% and a morbidity of 20-60%. Securing&#xD;
      this procedure is a major public health issue. The non-invasive ventilation is a technique&#xD;
      commonly used postoperatively in acute respiratory distress and in the treatment of sleep&#xD;
      apnea syndromes. Through its effect on oxygenation and pulmonary function parameters, the&#xD;
      non-invasive ventilation achieved during 7 days minimum before the intervention could&#xD;
      significantly reduce postoperative complications in patients with an obstructive or&#xD;
      restrictive disorder, obesity or chronic heart failure.&#xD;
&#xD;
      The aim of the study is to demonstrate that the non-invasive ventilation in two pressure&#xD;
      levels achieved during at least 7 days before surgery lung resection (lobectomy or&#xD;
      segmentectomy) halved the pulmonary and cardiovascular postoperative patients with&#xD;
      obstructive ventilatory disorder or restrictive, obesity or chronic heart failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 8, 2012</start_date>
  <completion_date type="Actual">October 25, 2017</completion_date>
  <primary_completion_date type="Actual">October 25, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reduction of pulmonary complications and cardiovascular postoperative</measure>
    <time_frame>1 month</time_frame>
    <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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Identifying sub-groups of patients</measure>
    <time_frame>1 month</time_frame>
    <description>Identify subgroups of patients benefiting most from a non-invasive ventilation preoperatively and safety of this technique preoperatively.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Surgery for Primary Lung Cancer</condition>
  <arm_group>
    <arm_group_label>Manufacturer VPAP ST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>7 days minimum non-invasive ventilation at 2 levels of pressure (BPAP) to the intervention.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>usual advice</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Manufacturer (VPAP ST)</intervention_name>
    <description>non-invasive ventilation in two pressure levels 7 days before surgery</description>
    <arm_group_label>Manufacturer VPAP ST</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient over 18 years, to benefit from surgery scheduled for lung resection (lobectomy&#xD;
             or segmentectomy) for primary lung cancer and having signed an informed consent.&#xD;
&#xD;
        AND&#xD;
&#xD;
          -  Trouble obstructive (FEV / FVC &lt;70% and FEV &lt;80% predicted)&#xD;
&#xD;
        Or restrictive (FVC &lt;80% or TLC &lt;80%)&#xD;
&#xD;
        Or decrease in the ratio TLCO / VA &lt;60%&#xD;
&#xD;
        Or history of respiratory failure with hypercapnic Pa CO2&gt; 45 mmHg in the year preceding&#xD;
        surgery&#xD;
&#xD;
        Or long-term oxygen&#xD;
&#xD;
        Or heart failure (clinical signs of heart failure and LVEF &lt;55% or disorder of relaxation&#xD;
        on echocardiography or atrial fibrillation)&#xD;
&#xD;
        Or history of acute cardiogenic pulmonary edema.&#xD;
&#xD;
        Or obesity (BMI&gt; 30 kg/m2)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inability to consent&#xD;
&#xD;
          -  Patient declared inoperable given the comorbidities or refusing surgery or with&#xD;
             unresectable tumors.&#xD;
&#xD;
          -  Patient operable but with no comorbidities described in the inclusion criteria&#xD;
&#xD;
          -  Contraindications to the non-invasive ventilation:&#xD;
&#xD;
               -  Lack of understanding of the technical&#xD;
&#xD;
               -  facial malformation&#xD;
&#xD;
               -  Tight stenosis of the upper airway&#xD;
&#xD;
               -  uncontrollable vomiting&#xD;
&#xD;
               -  Unable to remove the mask&#xD;
&#xD;
               -  Cognitive impairment or severe psychiatric jeopardizing the observance of the NAV&#xD;
&#xD;
          -  Patient non-insured&#xD;
&#xD;
          -  Patient already on invasive ventilation or non-invasive&#xD;
&#xD;
          -  During Pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicolas PALEIRON, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Brest, Inter Army Hospital Clermont-Tonnerre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Centre Hospitalier du Pays d'Aix</name>
      <address>
        <city>Aix en Provence</city>
        <zip>13616</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Angers</name>
      <address>
        <city>Angers</city>
        <zip>49933</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Victor Dupouy</name>
      <address>
        <city>Argenteuil</city>
        <zip>95100</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Clinqiue du Grand Large</name>
      <address>
        <city>Brest</city>
        <zip>29200</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHRU de Brest - Hôpital Morvan</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inter Army Hospital, Clermont-Tonnerre</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inter Army Hospital</name>
      <address>
        <city>Clamart</city>
        <zip>92141</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHI Créteil</name>
      <address>
        <city>Créteil</city>
        <zip>94010</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Limoges</name>
      <address>
        <city>Limoges</city>
        <zip>87042</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital, Pasteur</name>
      <address>
        <city>Nice</city>
        <zip>06000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Pontchaillou</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Rouen</name>
      <address>
        <city>Rouen</city>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU Saint-Etienne</name>
      <address>
        <city>Saint-Etienne</city>
        <zip>42055</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Inter Army Hospital, Saint-Anne</name>
      <address>
        <city>Toulon</city>
        <zip>83041</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hôpital Nord Ouest Villefranche Sur Saône</name>
      <address>
        <city>Villefranche sur Saône</city>
        <zip>69655</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2018</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>September 28, 2018</last_update_submitted>
  <last_update_submitted_qc>September 28, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">October 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>primary lung cancer</keyword>
  <keyword>lobectomy</keyword>
  <keyword>pneumonectomy</keyword>
  <keyword>non-invasive ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Neoplasms</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01685580
org study id: RB 11.095 préOVNI
nct id: NCT01685580
lead sponsor: 
collaborator: 
has dmc: Yes
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Reduction of pulmonary complications and cardiovascular postoperative
time frame: 1 month
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.
measure: Identifying sub-groups of patients
time frame: 1 month
description: Identify subgroups of patients benefiting most from a non-invasive ventilation preoperatively and safety of this technique preoperatively.
arm group label: Manufacturer VPAP ST
arm group type: Experimental
description: 7 days minimum non-invasive ventilation at 2 levels of pressure (BPAP) to the intervention.
arm group label: No intervention
arm group type: No Intervention
description: usual advice
intervention type: Device
intervention name: Manufacturer (VPAP ST)
description: non-invasive ventilation in two pressure levels 7 days before surgery
arm group label: Manufacturer VPAP ST
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Nicolas PALEIRON, MD
role: Principal Investigator
affiliation: Brest, Inter Army Hospital Clermont-Tonnerre
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: France
responsible party type: Sponsor
mesh term: Lung Neoplasms