<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/NCT01666834</url>
  </required_header>
  <id_info>
    <org_study_id>zdyyicu3</org_study_id>
    <nct_id>NCT01666834</nct_id>
  </id_info>
  <brief_title>Cross-section Survey of Mechanical Ventilation and Acute Respiratory Distress Syndrome in China</brief_title>
  <official_title>Southeast Univerity</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Southeast University, China</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Peking Union Medical College Hospital</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Southeast University, China</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The characteristics and outcomes of a mixed group of critically ill patients who received&#xD;
      mechanical ventilation are not known in China.&#xD;
&#xD;
      A 1 month Cross-section survey will be performed with the aim of describing the&#xD;
      characteristics and outcomes of conventional mechanical ventilation and treatment of acute&#xD;
      respiratory distress syndrome in intensive care units in China.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      From August 31th 2012 to September 30th 2012, all patients admit to ICUs were screened,&#xD;
      mechanical patients and patients with ARDS be enrolled. The demographic characteristics,&#xD;
      diagnosis, formerly medical history, Ventilator indications, Ventilator data, other&#xD;
      respiratory treatments, weaning outcome and 28 day mortality, and the treatment of ARDS will&#xD;
      be recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">May 2013</completion_date>
  <primary_completion_date type="Actual">May 2013</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>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>percentange of mechanical ventilation</measure>
    <time_frame>1 month</time_frame>
    <description>in the onw month period, How many patients in the intensive care unit are ventilated.</description>
  </primary_outcome>
  <enrollment type="Actual">555</enrollment>
  <condition>Respiratory Failure</condition>
  <condition>Acute Respiratory Distress Syndrome</condition>
  <eligibility>
    <study_pop>
      <textblock>
        A mixed group of critically ill patients who received mechanical ventilation or patient&#xD;
        with ARDS&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for mechanical ventillation patients:&#xD;
&#xD;
        Meet one of the following criteria&#xD;
&#xD;
          1. Patients who were admitted to ICU from September 1st to 31th 2012, and received&#xD;
             invasive mechanical ventilation for more than 24 hours&#xD;
&#xD;
          2. Patients who were admitted to ICU from September 1st to 31th 2012, and received&#xD;
             non-invasive mechanical ventilation for more than 12 hours&#xD;
&#xD;
          3. Patients who were admitted to ICU from September 1st to 31th 2012, and who fulifll the&#xD;
             ARDS Berlin Definition or AECC Definiton&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. lesson than 18 years old or more than 85 years old&#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>Haibo Qiu, professor</last_name>
    <role>Study Director</role>
    <affiliation>southeast university</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Zhong-Da hospital, southeast univerty</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210009</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2013</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 14, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 16, 2012</study_first_posted>
  <last_update_submitted>January 2, 2017</last_update_submitted>
  <last_update_submitted_qc>January 2, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 4, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Southeast University, China</investigator_affiliation>
    <investigator_full_name>Ling Liu</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <keyword>mechanical ventilation, ARDS, Ventilator strategy, outcome</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>Respiratory Insufficiency</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/NCT01666834
org study id: zdyyicu3
nct id: NCT01666834
lead sponsor: 
collaborator: 
has dmc: No
The characteristics and outcomes of a mixed group of critically ill patients who received
      mechanical ventilation are not known in China.

      A 1 month Cross-section survey will be performed with the aim of describing the
      characteristics and outcomes of conventional mechanical ventilation and treatment of acute
      respiratory distress syndrome in intensive care units in China.
From August 31th 2012 to September 30th 2012, all patients admit to ICUs were screened,
      mechanical patients and patients with ARDS be enrolled. The demographic characteristics,
      diagnosis, formerly medical history, Ventilator indications, Ventilator data, other
      respiratory treatments, weaning outcome and 28 day mortality, and the treatment of ARDS will
      be recorded.
observational model: Cohort
time perspective: Cross-Sectional
measure: percentange of mechanical ventilation
time frame: 1 month
description: in the onw month period, How many patients in the intensive care unit are ventilated.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Haibo Qiu, professor
role: Study Director
affiliation: southeast university
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Southeast University, China
investigator full name: Ling Liu
investigator title: Dr.
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Respiratory Insufficiency
mesh term: Acute Lung Injury
mesh term: Syndrome