<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/NCT03238339</url>
  </required_header>
  <id_info>
    <org_study_id>cstc2016shmszx130034</org_study_id>
    <nct_id>NCT03238339</nct_id>
  </id_info>
  <brief_title>The Clinical Application and Popularization of Portable Home Noninvasive Ventilator</brief_title>
  <official_title>The Clinical Application and Popularization of Portable Home Noninvasive Ventilator</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mingdong Hu</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Third Military 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 subjects of this study are the chronic obstructive pulmonary disease (COPD) patients with&#xD;
      chronic II respiratory failure. The participants will be divided into two groups: The&#xD;
      Portable Home Noninvasive Ventilator treatment group and the routine home oxygen inhalation&#xD;
      treatment group. All subjects will be given a stable COPD regimen and conventional oxygen&#xD;
      therapy ,but the portable home noninvasive ventilator treatment group will need to wear a&#xD;
      portable non-invasive ventilator. Objective evaluation indexes were established during the&#xD;
      routine treatment, and two groups of subjects will be followed up for one year. Finally, the&#xD;
      clinical data of all subjects will be analyzed，and then the practicability of portable&#xD;
      wearable household noninvasive ventilator will be verified.The researchers will also build a&#xD;
      remote breathing data-monitoring platform based on mobile internet,and a community home&#xD;
      demonstration application point.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">September 15, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>The frequency of the chronic obstructive pulmonary disease(COPD) acute exacerbation.</measure>
    <time_frame>one year</time_frame>
    <description>Record the frequency of COPD acute exacerbation within one year</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The first onset time of the chronic obstructive pulmonary disease(COPD) acute exacerbation</measure>
    <time_frame>one year</time_frame>
    <description>Record the first onset time of COPD acute exacerbation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The number of hospitalizations due to the chronic obstructive pulmonary disease(COPD) acute exacerbation</measure>
    <time_frame>one year</time_frame>
    <description>Record the number of hospitalizations due to the COPD acute exacerbation</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Six Minute Walk Distance</measure>
    <time_frame>month0,month4,month8,month12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>pulmonary arterial pressure</measure>
    <time_frame>month0,month4,month8,month12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>arterial blood gas</measure>
    <time_frame>month0,month4,month8,month12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>routine analysis of blood</measure>
    <time_frame>month0,month4,month8,month12</time_frame>
  </other_outcome>
  <other_outcome>
    <measure>The change of cytokines expression</measure>
    <time_frame>month0,month4,month8,month12</time_frame>
    <description>The cytokines including IL8、IL13、TNF-a、INF-r、IFN-γ、LTB4.</description>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Pulmonary Disease, Chronic Obstructive</condition>
  <condition>Hypercapnic Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>The Portable Home Noninvasive Ventilator treatment group</arm_group_label>
    <description>The patients maintain a stable COPD regimen, and on the basis of conventional home oxygen therapy, a portable, wearable, non-invasive ventilator will be used.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Routine home oxygen therapy group</arm_group_label>
    <description>The patient maintained a stable COPD regimen and conventional home oxygen therapy.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The subjects were selected from the Department of respiration, Xinqiao Hospital of&#xD;
        Chongqing city.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  40 years old &lt; age &lt; 80 years old&#xD;
&#xD;
          -  COPD diagnosis was made according to GOLD guidelines&#xD;
&#xD;
          -  The subjects with chronic type II respiratory failure&#xD;
&#xD;
          -  The subjects with structural lung disease&#xD;
&#xD;
          -  The subjects signed informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The subjects suffering from COPD acute exacerbation&#xD;
&#xD;
          -  The subjects currently participating in other related products&#xD;
&#xD;
          -  The subjects with organ dysfunction because of liver,kidney, hematopoietic system and&#xD;
             serious metabolic disease endocrine system&#xD;
&#xD;
          -  The subjects with poor compliance&#xD;
&#xD;
          -  The subjects refused to sign the informed consent&#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_contact>
    <last_name>Hu Mingdong, MD</last_name>
    <phone>+86-13500362524</phone>
    <email>huhanshandd@163.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Emergency Department, Xinqiao Hospital, Third Military Medical University</name>
      <address>
        <city>Chongqing</city>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>HU MINGDONG, MD</last_name>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>July 31, 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>December 20, 2019</last_update_submitted>
  <last_update_submitted_qc>December 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 23, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Third Military Medical University</investigator_affiliation>
    <investigator_full_name>Mingdong Hu</investigator_full_name>
    <investigator_title>associate chief physician</investigator_title>
  </responsible_party>
  <keyword>Pulmonary Disease, Chronic Obstructive</keyword>
  <keyword>Respiratory Insufficiency</keyword>
  <keyword>Oxygen Inhalation Therapy</keyword>
  <keyword>Noninvasive Ventilation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Chronic Disease</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/NCT03238339
org study id: cstc2016shmszx130034
nct id: NCT03238339
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The subjects of this study are the chronic obstructive pulmonary disease (COPD) patients with
      chronic II respiratory failure. The participants will be divided into two groups: The
      Portable Home Noninvasive Ventilator treatment group and the routine home oxygen inhalation
      treatment group. All subjects will be given a stable COPD regimen and conventional oxygen
      therapy ,but the portable home noninvasive ventilator treatment group will need to wear a
      portable non-invasive ventilator. Objective evaluation indexes were established during the
      routine treatment, and two groups of subjects will be followed up for one year. Finally, the
      clinical data of all subjects will be analyzed，and then the practicability of portable
      wearable household noninvasive ventilator will be verified.The researchers will also build a
      remote breathing data-monitoring platform based on mobile internet,and a community home
      demonstration application point.
observational model: Case-Control
time perspective: Prospective
measure: The frequency of the chronic obstructive pulmonary disease(COPD) acute exacerbation.
time frame: one year
description: Record the frequency of COPD acute exacerbation within one year
measure: The first onset time of the chronic obstructive pulmonary disease(COPD) acute exacerbation
time frame: one year
description: Record the first onset time of COPD acute exacerbation
measure: The number of hospitalizations due to the chronic obstructive pulmonary disease(COPD) acute exacerbation
time frame: one year
description: Record the number of hospitalizations due to the COPD acute exacerbation
measure: Six Minute Walk Distance
time frame: month0,month4,month8,month12
measure: pulmonary arterial pressure
time frame: month0,month4,month8,month12
measure: arterial blood gas
time frame: month0,month4,month8,month12
measure: routine analysis of blood
time frame: month0,month4,month8,month12
measure: The change of cytokines expression
time frame: month0,month4,month8,month12
description: The cytokines including IL8、IL13、TNF-a、INF-r、IFN-γ、LTB4.
arm group label: The Portable Home Noninvasive Ventilator treatment group
description: The patients maintain a stable COPD regimen, and on the basis of conventional home oxygen therapy, a portable, wearable, non-invasive ventilator will be used.
arm group label: Routine home oxygen therapy group
description: The patient maintained a stable COPD regimen and conventional home oxygen therapy.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Hu Mingdong, MD
phone: +86-13500362524
email: huhanshandd@163.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: Third Military Medical University
investigator full name: Mingdong Hu
investigator title: associate chief physician
mesh term: Lung Diseases
mesh term: Respiratory Insufficiency
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Chronic Disease