xml: <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/NCT06014034</url>
    </required_header>
    <id_info>
      <org_study_id>Y75505-04</org_study_id>
      <nct_id>NCT06014034</nct_id>
    </id_info>
    <brief_title>Randomized Controlled Study of Programmed Weaning From Noninvasive Mechanical Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease</brief_title>
    <official_title>Randomized Controlled Study of Programmed Weaning From Noninvasive Mechanical Ventilation for Acute Exacerbation of Chronic Obstructive Pulmonary Disease</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University Third Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University Third Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Purpose of research:to explore a reasonable programmed withdrawal process of noninvasive&#xD;
        ventilation and thereby reduce the duration of noninvasive mechanical ventilation in patients&#xD;
        with acute exacerbations of chronic obstructive pulmonary disease.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a single-center, prospective, randomized controlled study. The study subjects were&#xD;
        patients with acute exacerbation of chronic obstructive pulmonary disease admitted to the&#xD;
        intensive care unit, who were randomized into the study group, that is, the programmed&#xD;
        withdrawal unit, and the control group was the traditional withdrawal unit (the attending&#xD;
        physician decided the NIV regimen according to the condition). The primary study endpoints of&#xD;
        the trial were complete evacuation of noninvasive ventilation (i. e. from the start of the&#xD;
        patient to noninvasive ventilation) or return of time to normal ventilation for patients with&#xD;
        a home non-invasive ventilator prior to acute exacerbation. Secondary study endpoints include&#xD;
        length of stay, stay and failure of non-invasive ventilation (failure of non-invasive&#xD;
        ventilation was defined as the patient requiring endotracheal intubation to invasive&#xD;
        ventilation or death).&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 12, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2024</completion_date>
    <primary_completion_date type="Anticipated">December 31, 2024</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Complete evacuation time of non-invasive ventilation</measure>
      <time_frame>At the end of non-invasive ventilation，through study completion, an average of 11 days</time_frame>
      <description>from the start of the patient to the absence of noninvasive ventilation or return to the level of normal ventilation time for patients with non-invasive ventilation on a home non-invasive ventilator before acute exacerbation</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Time in the ICU</measure>
      <time_frame>At the end of therapy in ICU，through study completion, an average of 14 days</time_frame>
      <description>from the start of the patient stay in ICU to the day leave from ICU</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>length of stay</measure>
      <time_frame>At the end of therapy in hospital, through study completion, an average of 20 days</time_frame>
      <description>from the start of the patient stay in hospital to leave from hospital</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Failure rate of non-invasive ventilation</measure>
      <time_frame>At the end of therapy in hospital, an average of 20 days</time_frame>
      <description>failure of non-invasive ventilation is defined as a patient requiring endotracheal intubation to invasive ventilation or death</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">50</enrollment>
    <condition>Acute Exacerbation of COPD</condition>
    <arm_group>
      <arm_group_label>Study group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Programmed Weaning From Noninvasive Mechanical Ventilation</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>this is the traditional withdrawal unit (the attending physician will decide the NIV regimen according to the condition).</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Programmed Weaning From Noninvasive Mechanical Ventilation</intervention_name>
      <description>Programmed withdrawal unit: daily morning review arterial blood gas analysis (since the 2nd, daily morning stop non-invasive ventilation 1 hours, 2 hours, 3 hours, 4 hours after check arterial blood gas analysis), blood gas results suggest respiratory acidosis compensatory period (pH value greater than 7.35) can reduce daily noninvasive ventilation time, namely the noninvasive ventilation use time for 24 hours, 20 hours, the third day 16 hours, the fourth 12 hours, fifth day 8 hours. If ABG indicates still acid decompensation, continue the non-invasive ventilation regimen of the previous day. If noninvasive ventilation failed, invasive mechanical ventilation was performed.</description>
      <arm_group_label>Study group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  It is defined that in patients with acute exacerbation of chronic obstructive&#xD;
               pulmonary disease, the arterial blood gas analysis was decompensation of respiratory&#xD;
               acidosis, and the pH value was 7.20-7.35&#xD;
  &#xD;
            -  Non-invasive mechanical ventilation was performed and it was well tolerated&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  younger than 40 years old&#xD;
  &#xD;
            -  pregnancy&#xD;
  &#xD;
            -  Human immunodeficiency virus (HIV) antibody was positive&#xD;
  &#xD;
            -  Hemodynamic instability&#xD;
  &#xD;
            -  Mechanical ventilation for endotracheal intubation and cardiopulmonary resuscitation&#xD;
               were disagreed&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Qingtao Zhou</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking University Third Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Feifan Zhao</last_name>
      <phone>+86-10-82265562</phone>
      <email>112947952@qq.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Qingtao Zhou</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking University Third Hospita</name>
        <address>
          <city>Beijing</city>
          <state>Beijing</state>
          <zip>100191</zip>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Qingtao Zhou, MD</last_name>
        <phone>86-10-82265562</phone>
        <email>zhouqingtaobysy@sina.com</email>
      </contact>
      <investigator>
        <last_name>Qingtao Zhou, MD</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>August 9, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 28, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 28, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>noninvasive mechanical ventilation</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>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06014034
  org study id: Y75505-04
  nct id: NCT06014034
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Purpose of research:to explore a reasonable programmed withdrawal process of noninvasive
        ventilation and thereby reduce the duration of noninvasive mechanical ventilation in patients
        with acute exacerbations of chronic obstructive pulmonary disease.
  This is a single-center, prospective, randomized controlled study. The study subjects were
        patients with acute exacerbation of chronic obstructive pulmonary disease admitted to the
        intensive care unit, who were randomized into the study group, that is, the programmed
        withdrawal unit, and the control group was the traditional withdrawal unit (the attending
        physician decided the NIV regimen according to the condition). The primary study endpoints of
        the trial were complete evacuation of noninvasive ventilation (i. e. from the start of the
        patient to noninvasive ventilation) or return of time to normal ventilation for patients with
        a home non-invasive ventilator prior to acute exacerbation. Secondary study endpoints include
        length of stay, stay and failure of non-invasive ventilation (failure of non-invasive
        ventilation was defined as the patient requiring endotracheal intubation to invasive
        ventilation or death).
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Complete evacuation time of non-invasive ventilation
  time frame: At the end of non-invasive ventilation，through study completion, an average of 11 days
  description: from the start of the patient to the absence of noninvasive ventilation or return to the level of normal ventilation time for patients with non-invasive ventilation on a home non-invasive ventilator before acute exacerbation
  measure: Time in the ICU
  time frame: At the end of therapy in ICU，through study completion, an average of 14 days
  description: from the start of the patient stay in ICU to the day leave from ICU
  measure: length of stay
  time frame: At the end of therapy in hospital, through study completion, an average of 20 days
  description: from the start of the patient stay in hospital to leave from hospital
  measure: Failure rate of non-invasive ventilation
  time frame: At the end of therapy in hospital, an average of 20 days
  description: failure of non-invasive ventilation is defined as a patient requiring endotracheal intubation to invasive ventilation or death
  arm group label: Study group
  arm group type: Experimental
  description: Programmed Weaning From Noninvasive Mechanical Ventilation
  arm group label: Control group
  arm group type: No Intervention
  description: this is the traditional withdrawal unit (the attending physician will decide the NIV regimen according to the condition).
  intervention type: Other
  intervention name: Programmed Weaning From Noninvasive Mechanical Ventilation
  description: Programmed withdrawal unit: daily morning review arterial blood gas analysis (since the 2nd, daily morning stop non-invasive ventilation 1 hours, 2 hours, 3 hours, 4 hours after check arterial blood gas analysis), blood gas results suggest respiratory acidosis compensatory period (pH value greater than 7.35) can reduce daily noninvasive ventilation time, namely the noninvasive ventilation use time for 24 hours, 20 hours, the third day 16 hours, the fourth 12 hours, fifth day 8 hours. If ABG indicates still acid decompensation, continue the non-invasive ventilation regimen of the previous day. If noninvasive ventilation failed, invasive mechanical ventilation was performed.
  arm group label: Study group
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Qingtao Zhou
  role: Principal Investigator
  affiliation: Peking University Third Hospital
  last name: Feifan Zhao
  phone: +86-10-82265562
  email: 112947952@qq.com
  last name: Qingtao Zhou
  facility: 
  status: Recruiting
  contact: 
  investigator: 
  country: China
  responsible party type: Sponsor
  mesh term: Lung Diseases, Obstructive
  mesh term: Pulmonary Disease, Chronic Obstructive