<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/NCT03238014</url>
  </required_header>
  <id_info>
    <org_study_id>GIRD201707</org_study_id>
    <nct_id>NCT03238014</nct_id>
  </id_info>
  <brief_title>Efficacy of High-intensity NPPV and Low-intensity NPPV in Patients With Chronic Hypercapnic COPD</brief_title>
  <acronym>NPPV;COPD</acronym>
  <official_title>Efficacy of High-intensity Noninvasive Positive Pressure Ventilation and Low-intensity Noninvasive Positive Pressure Ventilation in Patients With Chronic Hypercapnic Chronic Obstructive Pulmonary Disease</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>The First Affiliated Hospital of Guangzhou Medical University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>The First Affiliated Hospital of Guangzhou Medical University</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>
      High-intensity noninvasive positive pressure ventilation (NPPV), which can well improve the&#xD;
      gas exchange and reduce the work of breathing of patients, is a new strategy targeted at&#xD;
      maximally reducing arterial carbon dioxide. However, no definitive conclusions have been&#xD;
      drawn to decide whether high-intensity NPPV is the best setting for treating patients with&#xD;
      chronic hypercapnic COPD. For now, no unified method for setting up high-pressure NPPV has&#xD;
      been established. Most of the trials utilized gradually increased inspiratory positive airway&#xD;
      pressure depending on the patient's tolerance. However, from a respiratory physiology point&#xD;
      of view, excessive inspiratory positive airway pressure may lead to lung hyperinflation,&#xD;
      increased intrinsic positive end expiratory pressures, increased oxygen consumption, and&#xD;
      ineffective work of breathing.Therefore, seeking a method to establish individualized&#xD;
      high-intensity NPPV is of vital importance.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">August 1, 2017</start_date>
  <completion_date type="Anticipated">May 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2020</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>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Partial pressure of arterial blood carbon dioxide (PaCO2)</measure>
    <time_frame>12 weeks</time_frame>
    <description>Daytime arterial blood gas samples were taken with patients resting in a sitting position and breathing room air without having used NPPV for at least 1 hour.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Severe Respiratory Insufficiency (SRI) Questionnaire</measure>
    <time_frame>12 weeks</time_frame>
    <description>The SRI Questionnaire has good psychometric properties shown to be valid for chronic hypercapnic COPD patients receiving NPPV. It includes 49 items on seven subscales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Baseline Dyspnea Index/Transition Dyspnea Index</measure>
    <time_frame>12 weeks</time_frame>
    <description>Baseline Dyspnea Index/Transition Dyspnea Index provides a multidimensional measurement of dyspnea based on 3 components that evoke dyspnea in activities of daily living, in symptomatic individuals.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Chromic Respiratory Questionnaire</measure>
    <time_frame>12 weeks</time_frame>
    <description>Chromic Respiratory Questionnaire is uesd to measure the health related quality of life in patients with chronic respiratory disease.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>COPD assessment test</measure>
    <time_frame>12 weeks</time_frame>
    <description>The COPD Assessment Test is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pulmonary function</measure>
    <time_frame>12 weeks</time_frame>
    <description>Pulmonary function tests of lung mechanics - measurements of forced vital capacity, forced expiratory volume in 1 second, forced inspiratory flow rates, etc.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>6-minute walk test</measure>
    <time_frame>12 weeks</time_frame>
    <description>The 6-minute walk test plays a key role in evaluating functional exercise capacity, assessing prognosis and evaluating response to treatment across a wide range of respiratory diseases.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">14</enrollment>
  <condition>COPD</condition>
  <condition>Hypercapnic Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>High-intensity noninvasive ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>High-intensity noninvasive positive pressure ventilation aims at maximally improving PaCO2.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-intensity noninvasive ventilation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Low-intensity noninvasive positive pressure ventilation is a classic setting of noninvasive ventilation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Noninvasive positive pressure ventilation</intervention_name>
    <description>Noninvasive positive pressure ventilation used assist/control mode treat severe stable chronic obstructive pulmonary disease.</description>
    <arm_group_label>High-intensity noninvasive ventilation</arm_group_label>
    <arm_group_label>Low-intensity noninvasive ventilation</arm_group_label>
    <other_name>Noninvasive ventilation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Clinically stable with chronic hypercapnic COPD (baseline arterial carbon dioxide pressure&#xD;
        (PaCO2) of 50 mmHg or higher, measured resting in a sitting position and breathing room air&#xD;
        without having used NPPV for at least 1 hour)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other lung/pleural diseases or thoracic deformity&#xD;
&#xD;
          -  severe heart failure (New York Heart Association class IV), severe dysrhythmia&#xD;
&#xD;
          -  unstable angina, or malignant comorbidity&#xD;
&#xD;
          -  obesity (BMI ≥ 35 kg/m²)&#xD;
&#xD;
          -  severe obstructive sleep apnea syndrome&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rongchang Chen</last_name>
    <role>Study Director</role>
    <affiliation>Guangzhou Institute of Respiratory Disease</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Lili Guan</last_name>
    <phone>+8613422288665</phone>
    <email>dr_nickguan@163.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Luqian Zhou</last_name>
    <phone>+8613826098411</phone>
    <email>icelucy@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Guangzhou Institute of Respiratory Disease</name>
      <address>
        <city>Guangzhou</city>
        <state>Guangdong</state>
        <zip>510000</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rongchang Chen</last_name>
      <phone>+8615622236759</phone>
      <email>chenrcstatekeylab@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>February 2020</verification_date>
  <study_first_submitted>July 27, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 3, 2017</study_first_posted>
  <last_update_submitted>February 4, 2020</last_update_submitted>
  <last_update_submitted_qc>February 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>The First Affiliated Hospital of Guangzhou Medical University</investigator_affiliation>
    <investigator_full_name>Guan Lili</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>Respiratory Insufficiency</mesh_term>
    <mesh_term>Hypercapnia</mesh_term>
  </condition_browse>
  <!-- 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/NCT03238014
org study id: GIRD201707
nct id: NCT03238014
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
High-intensity noninvasive positive pressure ventilation (NPPV), which can well improve the
      gas exchange and reduce the work of breathing of patients, is a new strategy targeted at
      maximally reducing arterial carbon dioxide. However, no definitive conclusions have been
      drawn to decide whether high-intensity NPPV is the best setting for treating patients with
      chronic hypercapnic COPD. For now, no unified method for setting up high-pressure NPPV has
      been established. Most of the trials utilized gradually increased inspiratory positive airway
      pressure depending on the patient's tolerance. However, from a respiratory physiology point
      of view, excessive inspiratory positive airway pressure may lead to lung hyperinflation,
      increased intrinsic positive end expiratory pressures, increased oxygen consumption, and
      ineffective work of breathing.Therefore, seeking a method to establish individualized
      high-intensity NPPV is of vital importance.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: Partial pressure of arterial blood carbon dioxide (PaCO2)
time frame: 12 weeks
description: Daytime arterial blood gas samples were taken with patients resting in a sitting position and breathing room air without having used NPPV for at least 1 hour.
measure: Severe Respiratory Insufficiency (SRI) Questionnaire
time frame: 12 weeks
description: The SRI Questionnaire has good psychometric properties shown to be valid for chronic hypercapnic COPD patients receiving NPPV. It includes 49 items on seven subscales.
measure: Baseline Dyspnea Index/Transition Dyspnea Index
time frame: 12 weeks
description: Baseline Dyspnea Index/Transition Dyspnea Index provides a multidimensional measurement of dyspnea based on 3 components that evoke dyspnea in activities of daily living, in symptomatic individuals.
measure: Chromic Respiratory Questionnaire
time frame: 12 weeks
description: Chromic Respiratory Questionnaire is uesd to measure the health related quality of life in patients with chronic respiratory disease.
measure: COPD assessment test
time frame: 12 weeks
description: The COPD Assessment Test is a questionnaire for people with COPD. It is designed to measure the impact of COPD on a person's life, and how this changes over time.
measure: Pulmonary function
time frame: 12 weeks
description: Pulmonary function tests of lung mechanics - measurements of forced vital capacity, forced expiratory volume in 1 second, forced inspiratory flow rates, etc.
measure: 6-minute walk test
time frame: 12 weeks
description: The 6-minute walk test plays a key role in evaluating functional exercise capacity, assessing prognosis and evaluating response to treatment across a wide range of respiratory diseases.
arm group label: High-intensity noninvasive ventilation
arm group type: Experimental
description: High-intensity noninvasive positive pressure ventilation aims at maximally improving PaCO2.
arm group label: Low-intensity noninvasive ventilation
arm group type: Active Comparator
description: Low-intensity noninvasive positive pressure ventilation is a classic setting of noninvasive ventilation.
intervention type: Device
intervention name: Noninvasive positive pressure ventilation
description: Noninvasive positive pressure ventilation used assist/control mode treat severe stable chronic obstructive pulmonary disease.
arm group label: High-intensity noninvasive ventilation
arm group label: Low-intensity noninvasive ventilation
other name: Noninvasive ventilation
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Rongchang Chen
role: Study Director
affiliation: Guangzhou Institute of Respiratory Disease
last name: Lili Guan
phone: +8613422288665
email: dr_nickguan@163.com
last name: Luqian Zhou
phone: +8613826098411
email: icelucy@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Principal Investigator
investigator affiliation: The First Affiliated Hospital of Guangzhou Medical University
investigator full name: Guan Lili
investigator title: Principal Investigator
mesh term: Respiratory Insufficiency
mesh term: Hypercapnia