<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/NCT01704066</url>
  </required_header>
  <id_info>
    <org_study_id>CCCCTG-2012-ARDS-01</org_study_id>
    <secondary_id>2012BAI11B05</secondary_id>
    <nct_id>NCT01704066</nct_id>
  </id_info>
  <brief_title>Interobserver Variation in Applying a Radiographic Definition for Acute Respiratory Distress Syndrome (ARDS)</brief_title>
  <official_title>Interobserver Variation in Applying a Radiographic Definition for ARDS: Impact of a Training Set of Berlin ARDS Definition</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Society of Critical Care Medicine, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Society of Critical Care Medicine, China</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The original American-European Consensus Conference (AECC) definition of Acute Respiratory&#xD;
      Distress Syndrome (ARDS) required bilateral infiltrates consistent with pulmonary edema on&#xD;
      frontal chest X-ray (CXR), but there is poor inter-observer reliability in interpreting CXR&#xD;
      using this definition among intensivists and radiologists.&#xD;
&#xD;
      As a result, the newly published Berlin definition of ARDS specified that the CXR criterion&#xD;
      should include bilateral opacities consistent with pulmonary edema not fully explained by&#xD;
      effusions, lobar/lung collapse, or nodules/masses on CXR.&#xD;
&#xD;
      In order to improve inter-observer agreement, the panel have also developed a set of CXRs&#xD;
      judged as consistent, inconsistent, or equivocal for the diagnosis of ARDS.&#xD;
&#xD;
      The objective of this study is to investigate the impact of this training set on&#xD;
      inter-observer reliability in applying the radiographic definition for ARDS.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study is composed of 3 phases:&#xD;
&#xD;
      Phase 1: All participants will be required to independently interpret a set of 12 CXRs, as&#xD;
      provided by the consensus panel. The possible radiographic interpretations include&#xD;
      consistent, inconsistent, or equivocal for the diagnosis of ARDS.&#xD;
&#xD;
      Phase 2: Training materials adapted according to the recently published Berlin definition of&#xD;
      ARDS, with its expanded rationale and interpretation of all 12 CXRs, will be sent to all&#xD;
      participants.&#xD;
&#xD;
      Phase 3: The same set of 12 CXRs, in different order, will be sent to all participants for&#xD;
      interpretation for the second time.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>inter-observer agreement in the interpretation of CXRs for the diagnosis of ARDS</measure>
    <time_frame>immediately after reading the CXRs</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Impact of the training set on the inter-observer agreement on the interpretation of CXRs</measure>
    <time_frame>difference of inter-observer agreement before and after the training course</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">286</enrollment>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Training and education</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Intensivists working in the participating ICUs&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  intensivists working in the participating ICUs&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  those who could not participate both questionnaire surveys&#xD;
&#xD;
          -  those who have read the reference with the training set of CXRs before the study&#xD;
&#xD;
          -  those who have already known the objective of the study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Bin Du, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Peking Union Medical College Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2012</verification_date>
  <study_first_submitted>October 6, 2012</study_first_submitted>
  <study_first_submitted_qc>October 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 11, 2012</study_first_posted>
  <last_update_submitted>December 20, 2012</last_update_submitted>
  <last_update_submitted_qc>December 20, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 21, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Peking Union Medical College Hospital</investigator_affiliation>
    <investigator_full_name>Bin Du</investigator_full_name>
    <investigator_title>Professor and Director, Medical ICU</investigator_title>
  </responsible_party>
  <keyword>ARDS</keyword>
  <keyword>Chest radiograph</keyword>
  <keyword>Berlin Definition</keyword>
  <keyword>Inter-observer agreement</keyword>
  <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>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/NCT01704066
org study id: CCCCTG-2012-ARDS-01
secondary id: 2012BAI11B05
nct id: NCT01704066
lead sponsor: 
has dmc: No
The original American-European Consensus Conference (AECC) definition of Acute Respiratory
      Distress Syndrome (ARDS) required bilateral infiltrates consistent with pulmonary edema on
      frontal chest X-ray (CXR), but there is poor inter-observer reliability in interpreting CXR
      using this definition among intensivists and radiologists.

      As a result, the newly published Berlin definition of ARDS specified that the CXR criterion
      should include bilateral opacities consistent with pulmonary edema not fully explained by
      effusions, lobar/lung collapse, or nodules/masses on CXR.

      In order to improve inter-observer agreement, the panel have also developed a set of CXRs
      judged as consistent, inconsistent, or equivocal for the diagnosis of ARDS.

      The objective of this study is to investigate the impact of this training set on
      inter-observer reliability in applying the radiographic definition for ARDS.
The study is composed of 3 phases:

      Phase 1: All participants will be required to independently interpret a set of 12 CXRs, as
      provided by the consensus panel. The possible radiographic interpretations include
      consistent, inconsistent, or equivocal for the diagnosis of ARDS.

      Phase 2: Training materials adapted according to the recently published Berlin definition of
      ARDS, with its expanded rationale and interpretation of all 12 CXRs, will be sent to all
      participants.

      Phase 3: The same set of 12 CXRs, in different order, will be sent to all participants for
      interpretation for the second time.
observational model: Cohort
time perspective: Prospective
measure: inter-observer agreement in the interpretation of CXRs for the diagnosis of ARDS
time frame: immediately after reading the CXRs
measure: Impact of the training set on the inter-observer agreement on the interpretation of CXRs
time frame: difference of inter-observer agreement before and after the training course
intervention type: Other
intervention name: Training and education
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Bin Du, MD
role: Principal Investigator
affiliation: Peking Union Medical College Hospital
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Peking Union Medical College Hospital
investigator full name: Bin Du
investigator title: Professor and Director, Medical ICU
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
mesh term: Syndrome