<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/NCT03255356</url>
  </required_header>
  <id_info>
    <org_study_id>16-081</org_study_id>
    <nct_id>NCT03255356</nct_id>
  </id_info>
  <brief_title>Ventilation in Cardiac Surgery</brief_title>
  <acronym>VENICE</acronym>
  <official_title>International Multicentre Observational Trial of Perioperative Ventilatory Management in Cardiac Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Caen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Caen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate prospectively ventilatory practices in the&#xD;
      perioperative cardiac surgery period.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a International Multicentre Observational Trial on all adult cardiac surgery patients&#xD;
      with cardiopulmonary bypass (CPB).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">November 1, 2017</start_date>
  <completion_date type="Anticipated">December 2017</completion_date>
  <primary_completion_date type="Anticipated">December 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>incidence of use prophylactic protective mechanical ventilation defined with with low tidal volume (6 to 8 ml / kg based on the ideal body weight)</measure>
    <time_frame>1 day</time_frame>
    <description>percent</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>incidence of using positive end-expiratory pressure</measure>
    <time_frame>1 day</time_frame>
    <description>(PEEP)&gt; 5 cmH2O</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of using at least 2 alveolar lung recruitment manoeuvres</measure>
    <time_frame>1 day</time_frame>
    <description>percent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of using a protective ventilation bundle combining prophylactic protective mechanical ventilation and at least 2 alveolar recruitment manoeuvres</measure>
    <time_frame>1 day</time_frame>
    <description>percent</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>incidence of postoperative pulmonary complications</measure>
    <time_frame>1 month postoperatively</time_frame>
    <description>percent</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Respiratory Complication</condition>
  <condition>Respiration, Artificial</condition>
  <condition>Anesthesia, General</condition>
  <condition>Bypass, Cardiopulmonary</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
    <description>An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Survey</intervention_name>
    <description>An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria.</description>
    <arm_group_label>Cohort</arm_group_label>
    <other_name>not adapted</other_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All adult cardiac surgery patients with cardiopulmonary bypass (CPB).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  All consecutive cardiac surgery patients with CPB during one predefined period,&#xD;
&#xD;
          -  Elective or urgent surgery as defined by EuroSCORE2.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Refusal of consent,&#xD;
&#xD;
          -  Pregnant women,&#xD;
&#xD;
          -  Age &lt; 18 years,&#xD;
&#xD;
          -  Heart transplant, ECLS, ventricular assist&#xD;
&#xD;
          -  Emergency or salvage surgery as defined by EuroSCORE2&#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>Marc-Olivier Fischer, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital of Caen</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marc-Olivier Fischer, MD, PhD</last_name>
    <phone>+33 2 31 06 31 06</phone>
    <email>fischer-mo@chu-caen.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Jennifer Brunet, MD</last_name>
    <phone>33 2 31 06 31 06</phone>
    <email>brunet-j@chu-caen.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CUB Erasm, Université libre de Bruxelles</name>
      <address>
        <city>Brussels</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <contact>
      <last_name>Alexandre Joosten, MD</last_name>
      <email>joosten-alexandre@hotmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Universidade Federal de São Paulo (UNIFESP)</name>
      <address>
        <city>Brasil</city>
        <country>Brazil</country>
      </address>
    </facility>
    <contact>
      <last_name>Caetano Nigro Neto, MD</last_name>
      <email>caenigro@uol.com.br</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>General University Hospital</name>
      <address>
        <city>Praha</city>
        <country>Czechia</country>
      </address>
    </facility>
    <contact>
      <last_name>Jan Kunstyr, MD</last_name>
      <email>jkunstyr@gmail.com</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Caen University Hospital</name>
      <address>
        <city>Caen</city>
        <zip>14 000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Klinik für Anästhesiologie und Intensivmedizin</name>
      <address>
        <city>Jena</city>
        <zip>07747</zip>
        <country>Germany</country>
      </address>
    </facility>
    <contact>
      <last_name>Christoph Sponholz, MD</last_name>
      <email>christoph.sponholz@med.uni-jena.de</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Universitaria</name>
      <address>
        <city>Pisa</city>
        <country>Italy</country>
      </address>
    </facility>
    <contact>
      <last_name>Fabio Guarracino, MD</last_name>
      <email>f.guarracino@ao-pisa.toscana.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Osaka city University Graduate school of Medecine</name>
      <address>
        <city>Osaki</city>
        <zip>545-8586</zip>
        <country>Japan</country>
      </address>
    </facility>
    <contact>
      <last_name>Koichi Koichi, MD</last_name>
      <email>suehirokoichi@yahoo.co.jp</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>VU University Hospital</name>
      <address>
        <city>Amsterdam</city>
        <country>Netherlands</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St Olav University Hospital</name>
      <address>
        <city>Trondheim</city>
        <country>Norway</country>
      </address>
    </facility>
    <contact>
      <last_name>Idar KIRKEBY-GARSTAD</last_name>
    </contact>
    <contact_backup>
      <email>idar.kirkeby-garstad@ntnu.no</email>
    </contact_backup>
  </location>
  <location>
    <facility>
      <name>Wroclaw Medical University</name>
      <address>
        <city>Wrocław</city>
        <country>Poland</country>
      </address>
    </facility>
    <contact>
      <last_name>Waldemar Gozdzik, MD</last_name>
      <email>waldemar.gozdzik@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>Czechia</country>
    <country>France</country>
    <country>Germany</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Netherlands</country>
    <country>Norway</country>
    <country>Poland</country>
  </location_countries>
  <reference>
    <citation>Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.</citation>
    <PMID>23902482</PMID>
  </reference>
  <reference>
    <citation>Lellouche F, Delorme M, Bussieres J, Ouattara A. Perioperative ventilatory strategies in cardiac surgery. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):381-95. doi: 10.1016/j.bpa.2015.08.006. Epub 2015 Sep 4.</citation>
    <PMID>26643102</PMID>
  </reference>
  <reference>
    <citation>Guldner A, Kiss T, Serpa Neto A, Hemmes SN, Canet J, Spieth PM, Rocco PR, Schultz MJ, Pelosi P, Gama de Abreu M. Intraoperative protective mechanical ventilation for prevention of postoperative pulmonary complications: a comprehensive review of the role of tidal volume, positive end-expiratory pressure, and lung recruitment maneuvers. Anesthesiology. 2015 Sep;123(3):692-713. doi: 10.1097/ALN.0000000000000754.</citation>
    <PMID>26120769</PMID>
  </reference>
  <verification_date>March 2017</verification_date>
  <study_first_submitted>June 12, 2017</study_first_submitted>
  <study_first_submitted_qc>August 18, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 21, 2017</study_first_posted>
  <last_update_submitted>August 18, 2017</last_update_submitted>
  <last_update_submitted_qc>August 18, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 21, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Postoperative pulmonary complications</keyword>
  <keyword>Protective mechanical ventilation</keyword>
  <keyword>Alveolar lung recruitment manoeuvres</keyword>
  <keyword>Cardiac Surgery Procedures</keyword>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03255356
org study id: 16-081
nct id: NCT03255356
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to evaluate prospectively ventilatory practices in the
      perioperative cardiac surgery period.
This is a International Multicentre Observational Trial on all adult cardiac surgery patients
      with cardiopulmonary bypass (CPB).
observational model: Cohort
time perspective: Prospective
measure: incidence of use prophylactic protective mechanical ventilation defined with with low tidal volume (6 to 8 ml / kg based on the ideal body weight)
time frame: 1 day
description: percent
measure: incidence of using positive end-expiratory pressure
time frame: 1 day
description: (PEEP)> 5 cmH2O
measure: incidence of using at least 2 alveolar lung recruitment manoeuvres
time frame: 1 day
description: percent
measure: incidence of using a protective ventilation bundle combining prophylactic protective mechanical ventilation and at least 2 alveolar recruitment manoeuvres
time frame: 1 day
description: percent
measure: incidence of postoperative pulmonary complications
time frame: 1 month postoperatively
description: percent
arm group label: Cohort
description: An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria.
intervention type: Other
intervention name: Survey
description: An anonymised questionnaire will be answered for each includable consecutive patient after verifying the absence of exclusion criteria.
arm group label: Cohort
other name: not adapted
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Marc-Olivier Fischer, MD, PhD
role: Principal Investigator
affiliation: University Hospital of Caen
last name: Marc-Olivier Fischer, MD, PhD
phone: +33 2 31 06 31 06
email: fischer-mo@chu-caen.fr
last name: Jennifer Brunet, MD
phone: 33 2 31 06 31 06
email: brunet-j@chu-caen.fr
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
facility: 
facility: 
contact: 
facility: 
contact: 
facility: 
contact: 
facility: 
facility: 
contact: 
contact backup: 
facility: 
contact: 
country: Belgium
country: Brazil
country: Czechia
country: France
country: Germany
country: Italy
country: Japan
country: Netherlands
country: Norway
country: Poland
citation: Futier E, Constantin JM, Paugam-Burtz C, Pascal J, Eurin M, Neuschwander A, Marret E, Beaussier M, Gutton C, Lefrant JY, Allaouchiche B, Verzilli D, Leone M, De Jong A, Bazin JE, Pereira B, Jaber S; IMPROVE Study Group. A trial of intraoperative low-tidal-volume ventilation in abdominal surgery. N Engl J Med. 2013 Aug 1;369(5):428-37. doi: 10.1056/NEJMoa1301082.
PMID: 23902482
citation: Lellouche F, Delorme M, Bussieres J, Ouattara A. Perioperative ventilatory strategies in cardiac surgery. Best Pract Res Clin Anaesthesiol. 2015 Sep;29(3):381-95. doi: 10.1016/j.bpa.2015.08.006. Epub 2015 Sep 4.
PMID: 26643102
citation: Guldner A, Kiss T, Serpa Neto A, Hemmes SN, Canet J, Spieth PM, Rocco PR, Schultz MJ, Pelosi P, Gama de Abreu M. Intraoperative protective mechanical ventilation for prevention of postoperative pulmonary complications: a comprehensive review of the role of tidal volume, positive end-expiratory pressure, and lung recruitment maneuvers. Anesthesiology. 2015 Sep;123(3):692-713. doi: 10.1097/ALN.0000000000000754.
PMID: 26120769
responsible party type: Sponsor
sharing ipd: No