<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/NCT03020394</url>
  </required_header>
  <id_info>
    <org_study_id>2016YFC1304304-3</org_study_id>
    <nct_id>NCT03020394</nct_id>
  </id_info>
  <brief_title>Respiratory Support in Severe Chronic Obstructive Pulmonary Disease Exacerbation</brief_title>
  <official_title>Comparison of High Flow Nasal Cannula, Noninvasive Positive Ventilation (NPPV) and Invasive Positive Ventilation (IPPV) in Severe Chronic Obstructive Pulmonary Disease Exacerbation (AECOPD)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>China-Japan Friendship Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>China-Japan Friendship Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Preliminary studies have shown that NPPV can avoid tracheal intubation in 40% to 60% patients&#xD;
      who have severe exacerbation of COPD. Recently, large-scale comparative effectiveness&#xD;
      research (CER) also found that compared with invasive ventilation, NPPV can reduce mortality&#xD;
      rates. But there's no high-quality clinical studies which can confirm this. Therefore,&#xD;
      investigators believe that NPPV can avoid intubation in patients with severe exacerbation of&#xD;
      COPD in ICU with perfect monitoring conditions and reasonable human resource allocation, in&#xD;
      order to reduce IMV-related complications and improve patients' outcomes.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In part of the patients who were AECOPD with pH &lt;7.25 , preliminary studies have shown that&#xD;
      NPPV can avoid tracheal intubation in 40% to 60% patients, and also reduce the incidence of&#xD;
      VAP. Recently, large-scale comparative effectiveness research (CER) also found that compared&#xD;
      with invasive ventilation, NPPV can reduce mortality rates. At present, there's no&#xD;
      high-quality clinical studies which can confirm this, and clinical guidelines do not have a&#xD;
      recommendation on the use of NPPV in these patients. Therefore, investigators believe that&#xD;
      NPPV can avoid intubation in patients with severe exacerbation of COPD in ICU with perfect&#xD;
      monitoring conditions and reasonable human resource allocation, as well as the progress of&#xD;
      medical technology in NPPV in recent years, in order to reduce IMV-related complications and&#xD;
      improve patients' outcomes.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>The incidence of ventilator-associated pneumonia (VAP)</measure>
    <time_frame>90days</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>The all cause mortality of ICU and hospitalization</measure>
    <time_frame>90 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The length of stay of ICU and hospitalization</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The length of stay of mechanical ventilation</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">208</enrollment>
  <condition>COPD Exacerbation</condition>
  <arm_group>
    <arm_group_label>Noninvasive ventilation</arm_group_label>
    <description>Noninvasive positive pressure ventilation is achieved by Philips Respironics V60/Vision ventilator. Choose bilevel positive airway pressure mode, and adjust the fraction of inspire oxygen(FiO2) or oxygen flow rate to maintain patient's oxygen saturation(SpO2) between 88% to 92%. Parameter adjustment and weaning of NPPV follow the protocols used before.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Invasive ventilation</arm_group_label>
    <description>Intubated immediately and connected to the ventilator. Parameter adjustment and weaning of IPPV follow the protocols used before.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High flow nasal cannula</arm_group_label>
    <description>High flow nasal cannula of different models (large, medium and small) are selected depending on the size and comfort of the patient's nostrils. Adjusting the oxygen flow rate (O2 Flow) maintains the patient's SpO2 88% to 92%. The flow was initially adjusted to 25 L/min and the flow was gradually adjusted to the patient's maximum tolerance. The inspiratory gas temperature (31 to 37 °C) was set to the patient's maximum tolerance level. If the patient's condition deteriorates and the tracheal intubation standard is met , the patient is recommended to undergo invasive ventilation treatment, but the choice of the final respiratory support method should be decided by the attending physician, patient and family.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        All patients with acute exacerbation of chronic obstructive pulmonary disease in medical&#xD;
        ICU.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  AECOPD;&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refuse to engage in the study;&#xD;
&#xD;
          -  have been included in other study.&#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>Qingyuan Zhan, M.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>China-Japan Friendship Hospital</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jingen Xia, Master</last_name>
    <phone>13466396561</phone>
    <email>xiajingen_00632@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>China-Japan Friendship hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100028</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Chen Wang, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>January 2020</verification_date>
  <study_first_submitted>January 9, 2017</study_first_submitted>
  <study_first_submitted_qc>January 11, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>January 13, 2020</last_update_submitted>
  <last_update_submitted_qc>January 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>China-Japan Friendship Hospital</investigator_affiliation>
    <investigator_full_name>Qingyuan Zhan</investigator_full_name>
    <investigator_title>Head of Pulmonary and Critical care medicine ward 4</investigator_title>
  </responsible_party>
  <keyword>COPD Exacerbation</keyword>
  <keyword>Noninvasive Positive Ventilation</keyword>
  <keyword>Invasive Positive Ventilation</keyword>
  <keyword>severe</keyword>
  <keyword>High flow nasal cannula</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Disease Progression</mesh_term>
  </condition_browse>
  <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/NCT03020394
org study id: 2016YFC1304304-3
nct id: NCT03020394
lead sponsor: 
has dmc: No
Preliminary studies have shown that NPPV can avoid tracheal intubation in 40% to 60% patients
      who have severe exacerbation of COPD. Recently, large-scale comparative effectiveness
      research (CER) also found that compared with invasive ventilation, NPPV can reduce mortality
      rates. But there's no high-quality clinical studies which can confirm this. Therefore,
      investigators believe that NPPV can avoid intubation in patients with severe exacerbation of
      COPD in ICU with perfect monitoring conditions and reasonable human resource allocation, in
      order to reduce IMV-related complications and improve patients' outcomes.
In part of the patients who were AECOPD with pH <7.25 , preliminary studies have shown that
      NPPV can avoid tracheal intubation in 40% to 60% patients, and also reduce the incidence of
      VAP. Recently, large-scale comparative effectiveness research (CER) also found that compared
      with invasive ventilation, NPPV can reduce mortality rates. At present, there's no
      high-quality clinical studies which can confirm this, and clinical guidelines do not have a
      recommendation on the use of NPPV in these patients. Therefore, investigators believe that
      NPPV can avoid intubation in patients with severe exacerbation of COPD in ICU with perfect
      monitoring conditions and reasonable human resource allocation, as well as the progress of
      medical technology in NPPV in recent years, in order to reduce IMV-related complications and
      improve patients' outcomes.
observational model: Cohort
time perspective: Prospective
measure: The incidence of ventilator-associated pneumonia (VAP)
time frame: 90days
measure: The all cause mortality of ICU and hospitalization
time frame: 90 days
measure: The length of stay of ICU and hospitalization
time frame: 90 days
measure: The length of stay of mechanical ventilation
time frame: 90 days
arm group label: Noninvasive ventilation
description: Noninvasive positive pressure ventilation is achieved by Philips Respironics V60/Vision ventilator. Choose bilevel positive airway pressure mode, and adjust the fraction of inspire oxygen(FiO2) or oxygen flow rate to maintain patient's oxygen saturation(SpO2) between 88% to 92%. Parameter adjustment and weaning of NPPV follow the protocols used before.
arm group label: Invasive ventilation
description: Intubated immediately and connected to the ventilator. Parameter adjustment and weaning of IPPV follow the protocols used before.
arm group label: High flow nasal cannula
description: High flow nasal cannula of different models (large, medium and small) are selected depending on the size and comfort of the patient's nostrils. Adjusting the oxygen flow rate (O2 Flow) maintains the patient's SpO2 88% to 92%. The flow was initially adjusted to 25 L/min and the flow was gradually adjusted to the patient's maximum tolerance. The inspiratory gas temperature (31 to 37 °C) was set to the patient's maximum tolerance level. If the patient's condition deteriorates and the tracheal intubation standard is met , the patient is recommended to undergo invasive ventilation treatment, but the choice of the final respiratory support method should be decided by the attending physician, patient and family.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Qingyuan Zhan, M.D.
role: Principal Investigator
affiliation: China-Japan Friendship Hospital
last name: Jingen Xia, Master
phone: 13466396561
email: xiajingen_00632@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: China-Japan Friendship Hospital
investigator full name: Qingyuan Zhan
investigator title: Head of Pulmonary and Critical care medicine ward 4
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Disease Progression
sharing ipd: No