<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/NCT02981589</url>
  </required_header>
  <id_info>
    <org_study_id>BeijingCYH-ICU-003</org_study_id>
    <nct_id>NCT02981589</nct_id>
  </id_info>
  <brief_title>Weaning Outcome From Invasive Mechanical Ventilation</brief_title>
  <official_title>Weaning Outcome From Invasive Mechanical Ventilation: a Prospective, Observational Cohort Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Beijing Chao Yang Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Beijing Chao Yang Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of the present study was to explore the weaning failure rate from invasive&#xD;
      mechanical ventilation and to identify risk factors of weaning failure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Anticipated">March 31, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Weaning failure rate</measure>
    <time_frame>3.5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Spontaneous breathing trial failure rate</measure>
    <time_frame>3.5 years</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Extubation failure rate</measure>
    <time_frame>3.5 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU mortality</measure>
    <time_frame>3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital mortality</measure>
    <time_frame>3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>3.5 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>3.5 years</time_frame>
  </secondary_outcome>
  <enrollment type="Anticipated">300</enrollment>
  <condition>Patients Requiring Endotracheal Intubation and Invasive Mechanical Ventilation</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Invasive mechanical ventilation</intervention_name>
    <description>Invasive ventilation was performed to all eligible patients. When patients met predefined criteria, spontaneous breathing trial was performed. Given spontaneous breathing trial passed, patients were extubated; on the contrary, patients would continue to receive invasive ventilation. If patients had respiratory failure after extubation, reintubation and invasive ventilation were necessary.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients requiring endotracheal intubation and invasive mechanical ventilation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Requiring endotracheal intubation and invasive mechanical ventilation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Duration of invasive mechanical ventilation &lt; 48 hours；&#xD;
&#xD;
          -  Presence of tracheostomy；&#xD;
&#xD;
          -  Presence of upper airway obstruction.&#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>Zujin Luo, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Beijing Chao Yang Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Zujin Luo, MD</last_name>
    <email>xmjg2002@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Respiratory intensive care unit, Beijing Chao Yang Hospital Jingxi Campus</name>
      <address>
        <city>Beiling</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Zujin Luo, MD</last_name>
      <email>xmjg2002@163.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>December 1, 2016</study_first_submitted>
  <study_first_submitted_qc>December 1, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 5, 2016</study_first_posted>
  <last_update_submitted>June 30, 2021</last_update_submitted>
  <last_update_submitted_qc>June 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">July 2, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Beijing Chao Yang Hospital</investigator_affiliation>
    <investigator_full_name>Zujin Luo</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <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/NCT02981589
org study id: BeijingCYH-ICU-003
nct id: NCT02981589
lead sponsor: 
has dmc: Yes
The main purpose of the present study was to explore the weaning failure rate from invasive
      mechanical ventilation and to identify risk factors of weaning failure.
observational model: Cohort
time perspective: Prospective
measure: Weaning failure rate
time frame: 3.5 years
measure: Spontaneous breathing trial failure rate
time frame: 3.5 years
measure: Extubation failure rate
time frame: 3.5 years
measure: ICU mortality
time frame: 3.5 years
measure: Hospital mortality
time frame: 3.5 years
measure: ICU length of stay
time frame: 3.5 years
measure: Hospital length of stay
time frame: 3.5 years
intervention type: Device
intervention name: Invasive mechanical ventilation
description: Invasive ventilation was performed to all eligible patients. When patients met predefined criteria, spontaneous breathing trial was performed. Given spontaneous breathing trial passed, patients were extubated; on the contrary, patients would continue to receive invasive ventilation. If patients had respiratory failure after extubation, reintubation and invasive ventilation were necessary.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Zujin Luo, MD
role: Principal Investigator
affiliation: Beijing Chao Yang Hospital
last name: Zujin Luo, MD
email: xmjg2002@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Chao Yang Hospital
investigator full name: Zujin Luo
investigator title: MD
sharing ipd: No