<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/NCT01683578</url>
  </required_header>
  <id_info>
    <org_study_id>PulmEngineering-2012-01</org_study_id>
    <nct_id>NCT01683578</nct_id>
  </id_info>
  <brief_title>Protective Variable Ventilation for Open Abdominal Surgery</brief_title>
  <acronym>PROVAR</acronym>
  <official_title>Effects of Variable Tidal Volumes During Open Abdominal Surgery on Lung Function and Systemic Inflammation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Technische Universität Dresden</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Technische Universität Dresden</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Variable ventilation has been shown to improve lung function and reduce lung damage as well&#xD;
      as inflammation in different models of the acute respiratory distress syndrome. Also,&#xD;
      variable ventilation is able to recruit lungs. The present study will investigate whether&#xD;
      variable as compared to non-variable ventilation improves post-operative lung function and&#xD;
      reduces systemic inflammation in patients submitted to open abdominal surgery.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">September 2013</completion_date>
  <primary_completion_date type="Actual">September 2013</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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Forced vital capacity</measure>
    <time_frame>Preoperative until 5th postoperative day</time_frame>
    <description>Forced vital capacity is assessed on the first postoperative day</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Arterial partial CO2 pressure</measure>
    <time_frame>Preoperative until 5th postoperative day</time_frame>
    <description>PacO2 on the first postoperative day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Peak expiratory flow</measure>
    <time_frame>Preoperative until 5th postoperative day</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Forced expiratory volume after 1 sec</measure>
    <time_frame>Preoperative until 5th postoperative day</time_frame>
    <description>Forced expiratory volume after 1 sec (FEV1) on first postoperative day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PaO2/FIO2</measure>
    <time_frame>Preoperative until 5th postoperative day</time_frame>
    <description>PaO2/FIO2 during the intraoperative period</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distribution of ventilation</measure>
    <time_frame>Preoperative until 5th postoperative day</time_frame>
    <description>Distribution of ventilation in lungs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Atelectasis</measure>
    <time_frame>Preoperative until 5th postoperative day</time_frame>
    <description>Amount of lung atelectasis on the first postoperative day</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postoperative pulmonary complications</measure>
    <time_frame>Preoperative until discharge from hospital</time_frame>
    <description>Development of postoperative pulmonary complications</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammation markers</measure>
    <time_frame>Preoperative until 5th postoperative day</time_frame>
    <description>Concentrations of interleukine(IL)-6, IL-8 and tumor necrosis factor(TNF)-alpha in plasma</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Development of Pulmonary Dysfunction Following Open Abdominal Surgery</condition>
  <arm_group>
    <arm_group_label>Variable Ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Variable tidal volumes with mean at 8 mL/kg of predicted body weight</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Non-variable Ventilation</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Conventional mechanical ventilation with tidal volume 8 mL/kg of predicted body weight</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Variable Ventilation</intervention_name>
    <arm_group_label>Variable Ventilation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective open abdominal surgery&#xD;
&#xD;
          -  ASA classification 2-3&#xD;
&#xD;
          -  age between 18 und 85 yrs&#xD;
&#xD;
          -  expected duration of surgery &gt; 3 h&#xD;
&#xD;
          -  expected extubation in the operation room&#xD;
&#xD;
          -  written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  chronic lung disease (except to COPD stadium I and II, and asthma)&#xD;
&#xD;
          -  Body Mass Index (BMI) &gt; 40&#xD;
&#xD;
          -  allergy to one of the drugs to be used for general anesthesia&#xD;
&#xD;
          -  participation in another interventional trial within 4 weeks before enrollment&#xD;
&#xD;
          -  addiction or any other disease that may interfere with the capacity of giving informed&#xD;
             consent&#xD;
&#xD;
          -  pregnant or breastfeeding women&#xD;
&#xD;
          -  women in reproductive age, except to those who fulfill one of the following:&#xD;
&#xD;
               -  post-menopause (12 months natural amenorrhoea, or 6 months amenorrhoea and serum&#xD;
                  FSH &gt; 40 mlU/ml&#xD;
&#xD;
               -  post-operative (6 weeks after two-sided ovariectomy)&#xD;
&#xD;
               -  routine and correct use of anticonceptional methods with failure rate &lt; 1 % per&#xD;
                  year&#xD;
&#xD;
               -  sexually not active&#xD;
&#xD;
               -  vasectomy of the partner&#xD;
&#xD;
          -  indication of low compliance with the protocol&#xD;
&#xD;
          -  contraindication for MRI examination&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcelo Gama de Abreu, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Klinikum Ludwigshafen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesiology and Intensive Care, University Hospital Carl Gustav Carus</name>
      <address>
        <city>Dresden</city>
        <state>Saxony</state>
        <zip>01307</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <link>
    <url>http://www.peg-dresden.de</url>
    <description>Homepage of the Pulmonary Engineering Group Dresden</description>
  </link>
  <verification_date>March 2016</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2012</study_first_posted>
  <last_update_submitted>March 30, 2016</last_update_submitted>
  <last_update_submitted_qc>March 30, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 31, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>mechanical ventilation</keyword>
  <keyword>lung function</keyword>
  <keyword>abdominal surgery, open</keyword>
  <keyword>systemic inflammation</keyword>
  <!-- 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/NCT01683578
org study id: PulmEngineering-2012-01
nct id: NCT01683578
lead sponsor: 
has dmc: No
Variable ventilation has been shown to improve lung function and reduce lung damage as well
      as inflammation in different models of the acute respiratory distress syndrome. Also,
      variable ventilation is able to recruit lungs. The present study will investigate whether
      variable as compared to non-variable ventilation improves post-operative lung function and
      reduces systemic inflammation in patients submitted to open abdominal surgery.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Forced vital capacity
time frame: Preoperative until 5th postoperative day
description: Forced vital capacity is assessed on the first postoperative day
measure: Arterial partial CO2 pressure
time frame: Preoperative until 5th postoperative day
description: PacO2 on the first postoperative day
measure: Peak expiratory flow
time frame: Preoperative until 5th postoperative day
measure: Forced expiratory volume after 1 sec
time frame: Preoperative until 5th postoperative day
description: Forced expiratory volume after 1 sec (FEV1) on first postoperative day
measure: PaO2/FIO2
time frame: Preoperative until 5th postoperative day
description: PaO2/FIO2 during the intraoperative period
measure: Distribution of ventilation
time frame: Preoperative until 5th postoperative day
description: Distribution of ventilation in lungs
measure: Atelectasis
time frame: Preoperative until 5th postoperative day
description: Amount of lung atelectasis on the first postoperative day
measure: Postoperative pulmonary complications
time frame: Preoperative until discharge from hospital
description: Development of postoperative pulmonary complications
measure: Inflammation markers
time frame: Preoperative until 5th postoperative day
description: Concentrations of interleukine(IL)-6, IL-8 and tumor necrosis factor(TNF)-alpha in plasma
arm group label: Variable Ventilation
arm group type: Active Comparator
description: Variable tidal volumes with mean at 8 mL/kg of predicted body weight
arm group label: Non-variable Ventilation
arm group type: No Intervention
description: Conventional mechanical ventilation with tidal volume 8 mL/kg of predicted body weight
intervention type: Other
intervention name: Variable Ventilation
arm group label: Variable Ventilation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Marcelo Gama de Abreu, MD, PhD
role: Principal Investigator
affiliation: Klinikum Ludwigshafen
facility: 
country: Germany
url: http://www.peg-dresden.de
description: Homepage of the Pulmonary Engineering Group Dresden
responsible party type: Sponsor