<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/NCT02985918</url>
  </required_header>
  <id_info>
    <org_study_id>BeijingCYH-ICU-004</org_study_id>
    <nct_id>NCT02985918</nct_id>
  </id_info>
  <brief_title>High-intensity Versus Conventional-intensity Noninvasive Positive Pressure Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: the HAPPEN Study (HAPPEN)</brief_title>
  <official_title>High-intensity Versus Conventional-intensity Noninvasive Positive Pressure Ventilation in Acute Exacerbation of Chronic Obstructive Pulmonary Disease: a Multicenter, Randomized, Controlled Trial</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main purpose of the present study is to verify whether, as compared with&#xD;
      conventional-intensity noninvasive positive pressure ventilation, high-intensity noninvasive&#xD;
      positive pressure ventilation may more effective in correcting hypercapnia, hence reducing&#xD;
      the need for intubation and improving survival in patients with acute exacerbation of chronic&#xD;
      obstructive pulmonary disease.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Actual">April 22, 2022</completion_date>
  <primary_completion_date type="Actual">January 31, 2022</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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Intubation rate</measure>
    <time_frame>1 year</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>The decrements of PaCO2 measured at 2 hours after enrollment.</measure>
    <time_frame>2 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The decrements of PaCO2 measured at 6 hours after enrollment.</measure>
    <time_frame>6 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The decrements of PaCO2 measured at 24 hours after enrollment.</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The decrements of PaCO2 measured at 48 hours after enrollment.</measure>
    <time_frame>48 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU mortality rate</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>28-day mortality rate</measure>
    <time_frame>28 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital survival rate</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>90-day mortality rate</measure>
    <time_frame>90 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ICU length of stay</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complication related to NPPV</measure>
    <time_frame>1 year</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Acute Exacerbation of Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>High-intensity NPPV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The patients will receive high-intensity noninvasive positive pressure ventilation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional-intensity NPPV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The patients will receive conventional-intensity noninvasive positive pressure ventilation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High-intensity NPPV</intervention_name>
    <description>The patients will receive noninvasive positive pressure ventilation using S/T mode. The inspiratory positive airway pressure will be initially set at 10 cmH2O, and will be continuously adjusted by increments/decrements of 1-2 cmH2O, according to subjects' tolerance (up to 30 cmH2O), to obtain a VT of 15 mL/kg of predicted body weight, and to achieve normocapnia as possible as it can.</description>
    <arm_group_label>High-intensity NPPV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional-intensity NPPV</intervention_name>
    <description>The patients will receive noninvasive positive pressure ventilation using S/T mode. The inspiratory positive airway pressure will be initially set at 10 cmH2O, and will be continuously adjusted by increments/decrements of 1-2 cmH2O, according to subjects' tolerance (up to 20 cmH2O), to obtain a VT of 10 mL/kg of predicted body weight.</description>
    <arm_group_label>Conventional-intensity NPPV</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of COPD according to the criteria of the Global Initiative for Chronic&#xD;
             Obstructive Lung Disease in 2016&#xD;
&#xD;
          -  Presence of acute exacerbation&#xD;
&#xD;
          -  Arterial pH &lt;7.35 with arterial carbon dioxide tension &gt;45 mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  age &lt;18 years&#xD;
&#xD;
          -  Excessive amount of respiratory secretions or weak cough&#xD;
&#xD;
          -  Upper airway obstruction&#xD;
&#xD;
          -  Recent oral, facial, or cranial trauma or surgery&#xD;
&#xD;
          -  Recent gastric or esophageal surgery&#xD;
&#xD;
          -  Severe abdominal distension&#xD;
&#xD;
          -  Active upper gastrointestinal bleeding&#xD;
&#xD;
          -  Cardiac or respiratory arrest;&#xD;
&#xD;
          -  Arterial oxygen tension/fraction of inspired oxygen (PaO2/FiO2) &lt;150 mmHg&#xD;
&#xD;
          -  Pneumothorax&#xD;
&#xD;
          -  Severe ventricular arrhythmia or myocardial ischemia&#xD;
&#xD;
          -  Severe hemodynamic instability despite fluid repletion and use of vasoactive agents&#xD;
&#xD;
          -  Severe metabolic acidosis&#xD;
&#xD;
          -  Refusal to receive NPPV&#xD;
&#xD;
          -  Lack of cooperation&#xD;
&#xD;
          -  Intolerance of NPPV&#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>
  <location>
    <facility>
      <name>The Second Hospital of Baoji</name>
      <address>
        <city>Baoji</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Hospital of Baoji</name>
      <address>
        <city>Baoji</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Chao-Yang Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Mentougou District Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Pinggu Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Beijing Renhe Hospital</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>People's Hospital of Beijing Huairou District</name>
      <address>
        <city>Beijing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Chongqing Xin-Qiao Hospital</name>
      <address>
        <city>Chongqing</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gongyi City People's Hospital</name>
      <address>
        <city>Gongyi</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Haicheng Central Hospital</name>
      <address>
        <city>Haicheng</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sir Run Run Shaw Hospital, Zhejiang University School of Medicine</name>
      <address>
        <city>Hangzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>People's Hospital of Hanshou</name>
      <address>
        <city>Hanshou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Hospital of University of South China</name>
      <address>
        <city>Hengyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Hospital of University of South China</name>
      <address>
        <city>Hengyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Henan Polytechnic University</name>
      <address>
        <city>Jiaozuo</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kaifeng Central Hospital</name>
      <address>
        <city>Kaifeng</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Henan University</name>
      <address>
        <city>Kaifeng</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of Kunming University of Science and Technology</name>
      <address>
        <city>Kunming</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Third Hospital of Mianyang</name>
      <address>
        <city>Mianyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>National Hospital of Guangxi Zhuang Autonomous Region</name>
      <address>
        <city>Nanning</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nanyang Central Hospital</name>
      <address>
        <city>Nanyang</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Sanmenxia Central Hospital</name>
      <address>
        <city>Sanmenxia</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Affiliated Hospital of North China University of Science of Technology</name>
      <address>
        <city>Tangshan</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>People's Hospital of Xinjiang Uygur Autonomous Region</name>
      <address>
        <city>Urumqi</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Jiaotong University</name>
      <address>
        <city>Xi'an</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Xi'an Medical University</name>
      <address>
        <city>Xian</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital of Zhengzhou University</name>
      <address>
        <city>Zhengzhou</city>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>May 2022</verification_date>
  <study_first_submitted>December 2, 2016</study_first_submitted>
  <study_first_submitted_qc>December 5, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 7, 2016</study_first_posted>
  <last_update_submitted>May 14, 2022</last_update_submitted>
  <last_update_submitted_qc>May 14, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">May 17, 2022</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>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT02985918
org study id: BeijingCYH-ICU-004
nct id: NCT02985918
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The main purpose of the present study is to verify whether, as compared with
      conventional-intensity noninvasive positive pressure ventilation, high-intensity noninvasive
      positive pressure ventilation may more effective in correcting hypercapnia, hence reducing
      the need for intubation and improving survival in patients with acute exacerbation of chronic
      obstructive pulmonary disease.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Intubation rate
time frame: 1 year
measure: The decrements of PaCO2 measured at 2 hours after enrollment.
time frame: 2 hours
measure: The decrements of PaCO2 measured at 6 hours after enrollment.
time frame: 6 hours
measure: The decrements of PaCO2 measured at 24 hours after enrollment.
time frame: 24 hours
measure: The decrements of PaCO2 measured at 48 hours after enrollment.
time frame: 48 hours
measure: ICU mortality rate
time frame: 1 year
measure: 28-day mortality rate
time frame: 28 days
measure: Hospital survival rate
time frame: 1 year
measure: 90-day mortality rate
time frame: 90 days
measure: ICU length of stay
time frame: 1 year
measure: Hospital length of stay
time frame: 1 year
measure: Complication related to NPPV
time frame: 1 year
arm group label: High-intensity NPPV
arm group type: Experimental
description: The patients will receive high-intensity noninvasive positive pressure ventilation.
arm group label: Conventional-intensity NPPV
arm group type: Active Comparator
description: The patients will receive conventional-intensity noninvasive positive pressure ventilation.
intervention type: Device
intervention name: High-intensity NPPV
description: The patients will receive noninvasive positive pressure ventilation using S/T mode. The inspiratory positive airway pressure will be initially set at 10 cmH2O, and will be continuously adjusted by increments/decrements of 1-2 cmH2O, according to subjects' tolerance (up to 30 cmH2O), to obtain a VT of 15 mL/kg of predicted body weight, and to achieve normocapnia as possible as it can.
arm group label: High-intensity NPPV
intervention type: Device
intervention name: Conventional-intensity NPPV
description: The patients will receive noninvasive positive pressure ventilation using S/T mode. The inspiratory positive airway pressure will be initially set at 10 cmH2O, and will be continuously adjusted by increments/decrements of 1-2 cmH2O, according to subjects' tolerance (up to 20 cmH2O), to obtain a VT of 10 mL/kg of predicted body weight.
arm group label: Conventional-intensity NPPV
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
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country: China
responsible party type: Principal Investigator
investigator affiliation: Beijing Chao Yang Hospital
investigator full name: Zujin Luo
investigator title: Principal Investigator
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive
sharing ipd: No