<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/NCT03250416</url>
  </required_header>
  <id_info>
    <org_study_id>ChongqingMU2</org_study_id>
    <nct_id>NCT03250416</nct_id>
  </id_info>
  <brief_title>Management of Noninvasive Ventilation in Hypoxemic Patients</brief_title>
  <official_title>The First Affiliated Hospital of Chongqing Medical University</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chongqing Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chongqing Medical University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigator aimed to manage noninvasive ventilation in patients with hypoxemic&#xD;
      respiratory failure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients with hypoxemic respiratory failure were enrolled in this study. The investigator&#xD;
      collected the data at beginning and first stage of noninvasive ventilation to analyze the&#xD;
      efficacy of noninvasive ventilation. To manage the noninvasive ventilation easily, the&#xD;
      investigator also aimed to develop a scale to predict the efficacy of noninvasive&#xD;
      ventilation, and used this scale to guide clinicians how to use noninvasive ventilation.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2017</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">September 30, 2021</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>30 Days</target_duration>
  <primary_outcome>
    <measure>Noninvasive ventilation failure</measure>
    <time_frame>From participation to 30 days</time_frame>
    <description>Noninvasive ventilation failure was defined as requirement of intubation.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mortality</measure>
    <time_frame>From participation to 30 days</time_frame>
    <description>Mortality in ICU and hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU stay</measure>
    <time_frame>From participation to 30 days</time_frame>
    <description>Length of ICU stay</description>
  </secondary_outcome>
  <enrollment type="Actual">2179</enrollment>
  <condition>Noninvasive Ventilation</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The main population is acute hypoxemic respiratory failure. The subgroup included ARDS,&#xD;
        pneumonia, sepsis and so on.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  PaO2/FiO2 less than 300; PaCO2 less than 50 mmHg; Respiratory rate more than 25&#xD;
             breaths/min or presence of labored breath.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Requirement of emergency intubation; Sequential use of noninvasive ventilation after&#xD;
             extubation;Use of noninvasive ventilation after accident extubation.&#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>Jun Duan, Dr</last_name>
    <role>Principal Investigator</role>
    <affiliation>First Affiliated Hospital of Chongqing Medical University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The First Affiliated Hospital ,Chongqing Medical Univercity</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400016</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>July 2022</verification_date>
  <study_first_submitted>August 11, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>July 5, 2022</last_update_submitted>
  <last_update_submitted_qc>July 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">July 7, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chongqing Medical University</investigator_affiliation>
    <investigator_full_name>Duan jun</investigator_full_name>
    <investigator_title>Doctor</investigator_title>
  </responsible_party>
  <!-- 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/NCT03250416
org study id: ChongqingMU2
nct id: NCT03250416
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The investigator aimed to manage noninvasive ventilation in patients with hypoxemic
      respiratory failure.
Patients with hypoxemic respiratory failure were enrolled in this study. The investigator
      collected the data at beginning and first stage of noninvasive ventilation to analyze the
      efficacy of noninvasive ventilation. To manage the noninvasive ventilation easily, the
      investigator also aimed to develop a scale to predict the efficacy of noninvasive
      ventilation, and used this scale to guide clinicians how to use noninvasive ventilation.
observational model: Case-Only
time perspective: Prospective
measure: Noninvasive ventilation failure
time frame: From participation to 30 days
description: Noninvasive ventilation failure was defined as requirement of intubation.
measure: Mortality
time frame: From participation to 30 days
description: Mortality in ICU and hospital
measure: ICU stay
time frame: From participation to 30 days
description: Length of ICU stay
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jun Duan, Dr
role: Principal Investigator
affiliation: First Affiliated Hospital of Chongqing Medical University
facility: 
country: China
responsible party type: Principal Investigator
investigator affiliation: Chongqing Medical University
investigator full name: Duan jun
investigator title: Doctor