<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/NCT01670747</url>
  </required_header>
  <id_info>
    <org_study_id>201208</org_study_id>
    <nct_id>NCT01670747</nct_id>
  </id_info>
  <brief_title>Evaluation of the Lung Recruitment and End-expiratory Lung Collapse in Acute Respiratory Distress Syndrome (ARDS)</brief_title>
  <official_title>Evaluation of the Lung Recruitment and End-expiratory Lung Collapse in Patients With Acute Respiratory Distress Syndrome</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Policlinico Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Policlinico Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study gas-exchange and respiratory mechanics variations to PEEP change will be&#xD;
      correlated to CT lung morphological modifications assessed at different airway pressures (5,&#xD;
      15, 30 and 45 cmH2O).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">March 2015</completion_date>
  <primary_completion_date type="Actual">March 2015</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>Computer Tomography (CT) scan lung recruitment and CT lung weight</measure>
    <time_frame>Study day (day 1)</time_frame>
    <description>Aim of the study is to determine the relationship between the opening pressures (recruitment) and closing pressures (PEEP) in order to prevent the opening and closing of the lung parenchyma</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">30</enrollment>
  <condition>ARDS: Acute Respiratory Distress Syndrome</condition>
  <arm_group>
    <arm_group_label>ARDS</arm_group_label>
    <description>Sedated and mechanically ventilated patients admitted to ICU</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>Chest computed tomography</intervention_name>
    <arm_group_label>ARDS</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients admitted to ICU with diagnosis of ARDS who required mechanical ventilation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of acute lung injury/ acute respiratory distress syndrome&#xD;
&#xD;
          -  Mechanical ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical diagnosis of chronic obstructive pulmonary disease&#xD;
&#xD;
          -  Clinical diagnosis of pneumothorax&#xD;
&#xD;
          -  Haemodynamic instability&#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>Chiumello Davide, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <reference>
    <citation>Gattinoni L, Caironi P, Cressoni M, Chiumello D, Ranieri VM, Quintel M, Russo S, Patroniti N, Cornejo R, Bugedo G. Lung recruitment in patients with the acute respiratory distress syndrome. N Engl J Med. 2006 Apr 27;354(17):1775-86. doi: 10.1056/NEJMoa052052.</citation>
    <PMID>16641394</PMID>
  </reference>
  <reference>
    <citation>Caironi P, Cressoni M, Chiumello D, Ranieri M, Quintel M, Russo SG, Cornejo R, Bugedo G, Carlesso E, Russo R, Caspani L, Gattinoni L. Lung opening and closing during ventilation of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2010 Mar 15;181(6):578-86. doi: 10.1164/rccm.200905-0787OC. Epub 2009 Nov 12.</citation>
    <PMID>19910610</PMID>
  </reference>
  <verification_date>March 2015</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 21, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>March 18, 2015</last_update_submitted>
  <last_update_submitted_qc>March 18, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">March 19, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Policlinico Hospital</investigator_affiliation>
    <investigator_full_name>Davide Chiumello</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
    <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
    <mesh_term>Acute Lung Injury</mesh_term>
    <mesh_term>Pulmonary Atelectasis</mesh_term>
    <mesh_term>Syndrome</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/NCT01670747
org study id: 201208
nct id: NCT01670747
lead sponsor: 
has dmc: No
In this study gas-exchange and respiratory mechanics variations to PEEP change will be
      correlated to CT lung morphological modifications assessed at different airway pressures (5,
      15, 30 and 45 cmH2O).
observational model: Cohort
time perspective: Prospective
measure: Computer Tomography (CT) scan lung recruitment and CT lung weight
time frame: Study day (day 1)
description: Aim of the study is to determine the relationship between the opening pressures (recruitment) and closing pressures (PEEP) in order to prevent the opening and closing of the lung parenchyma
arm group label: ARDS
description: Sedated and mechanically ventilated patients admitted to ICU
intervention type: Radiation
intervention name: Chest computed tomography
arm group label: ARDS
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Chiumello Davide, MD
role: Principal Investigator
affiliation: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
facility: 
country: Italy
citation: Gattinoni L, Caironi P, Cressoni M, Chiumello D, Ranieri VM, Quintel M, Russo S, Patroniti N, Cornejo R, Bugedo G. Lung recruitment in patients with the acute respiratory distress syndrome. N Engl J Med. 2006 Apr 27;354(17):1775-86. doi: 10.1056/NEJMoa052052.
PMID: 16641394
citation: Caironi P, Cressoni M, Chiumello D, Ranieri M, Quintel M, Russo SG, Cornejo R, Bugedo G, Carlesso E, Russo R, Caspani L, Gattinoni L. Lung opening and closing during ventilation of acute respiratory distress syndrome. Am J Respir Crit Care Med. 2010 Mar 15;181(6):578-86. doi: 10.1164/rccm.200905-0787OC. Epub 2009 Nov 12.
PMID: 19910610
responsible party type: Principal Investigator
investigator affiliation: Policlinico Hospital
investigator full name: Davide Chiumello
investigator title: MD
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Pulmonary Atelectasis
mesh term: Syndrome