<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/NCT03018470</url>
  </required_header>
  <id_info>
    <org_study_id>2017/015/SC</org_study_id>
    <nct_id>NCT03018470</nct_id>
  </id_info>
  <brief_title>Change in Breathing Pattern on Non-invasive Ventilation of COPD Patients Under Home Mechanical Ventilation</brief_title>
  <official_title>Usefulness of built-in Non-invasive Ventilator Software to Detect the Change in the Breathing Pattern of COPD Patients Under Home Mechanical Ventilation Before an Admission for Acute Exacerbation of COPD.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Acute exacerbation of COPD (AECOPD) worsen prognosis and quality of life of COPD patients.&#xD;
      Telemonitoring could be a useful tool for early identification of AECOPD. Parameters that&#xD;
      have to be monitored are not well defined.&#xD;
&#xD;
      Patients with severe COPD may use home non-invasive ventilation (NIV). NIV have built-in&#xD;
      software which are recording the breathing pattern of patients when used. The aim of this&#xD;
      study is to identify ventilation parameters that are modified at the early stage of an&#xD;
      AECOPD.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2017</start_date>
  <completion_date type="Actual">August 2017</completion_date>
  <primary_completion_date type="Actual">August 2017</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>Change of respiratory rate at the early onset of AECOPD</measure>
    <time_frame>10 days</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of tidal volume at the early onset of AECOPD</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of leaks at the early onset of AECOPD</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of length of use of NIV at the early onset of AECOPD</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of number of breaks during the use of NIV at the early onset of AECOPD</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of proportion of triggered breaths during the use of NIV at the early onset of AECOPD</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of proportion of asynchronisms during the use of NIV at the early onset of AECOPD</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the number of residual respiratory events during the use of NIV at the early onset of AECOPD</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of the inspiratory time during the use of NIV at the early onset of AECOPD</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensitivity and specificity of change in the breathing pattern under NIV to detect an AECOPD</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the change in symptoms and in the breathing pattern under NIV</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the length of the change in the breathing pattern under NIV and the length of inpatient stay</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between the importance of the change in the breathing pattern under NIV and the severity of the AECOPD</measure>
    <time_frame>10 days</time_frame>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">80</enrollment>
  <condition>Copd</condition>
  <condition>COPD Exacerbation</condition>
  <arm_group>
    <arm_group_label>Control cohort</arm_group_label>
    <description>Patient with COPD and home NIV admitted for planned respiratory review and without any sign of exacerbation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exacerbation cohort</arm_group_label>
    <description>Patient with COPD and home NIV admitted for acute exacerbation of COPD</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Outpatient exacerbation</arm_group_label>
    <description>Patient with COPD and home NIV admitted for planned respiratory review and with signs of acute exacerbation of COPD but not requiring inpatient management</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Analysis of data from NIV built-in software</intervention_name>
    <description>Analysis of breathing pattern using data obtained from NIV built-in software</description>
    <arm_group_label>Control cohort</arm_group_label>
    <arm_group_label>Exacerbation cohort</arm_group_label>
    <arm_group_label>Outpatient exacerbation</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All consecutive patients admitted to Rouen Respiratory unit with established COPD and home&#xD;
        non invasive ventilation&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed COPD according to GOLD guidelines&#xD;
&#xD;
          -  Established on home non invasive ventilation for more than 2 weeks&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  None&#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>Maxime Patout, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Rouen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Antoine Cuvelier, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Rouen</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Sophie Blouet</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Rouen</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Service de Pneumologie, Oncologie Thoracique et Soins Intensifs Respiratoires</name>
      <address>
        <city>Rouen</city>
        <state>Normandie</state>
        <zip>76031</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>May 25, 2018</last_update_submitted>
  <last_update_submitted_qc>May 25, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>Non invasive ventilation</keyword>
  <keyword>NIV</keyword>
  <keyword>Acute exacerbation COPD</keyword>
  <keyword>AECOPD</keyword>
  <keyword>Telemonitoring</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pulmonary Disease, Chronic Obstructive</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/NCT03018470
org study id: 2017/015/SC
nct id: NCT03018470
lead sponsor: 
has dmc: No
Acute exacerbation of COPD (AECOPD) worsen prognosis and quality of life of COPD patients.
      Telemonitoring could be a useful tool for early identification of AECOPD. Parameters that
      have to be monitored are not well defined.

      Patients with severe COPD may use home non-invasive ventilation (NIV). NIV have built-in
      software which are recording the breathing pattern of patients when used. The aim of this
      study is to identify ventilation parameters that are modified at the early stage of an
      AECOPD.
observational model: Cohort
time perspective: Prospective
measure: Change of respiratory rate at the early onset of AECOPD
time frame: 10 days
measure: Change of tidal volume at the early onset of AECOPD
time frame: 10 days
measure: Change of leaks at the early onset of AECOPD
time frame: 10 days
measure: Change of length of use of NIV at the early onset of AECOPD
time frame: 10 days
measure: Change of number of breaks during the use of NIV at the early onset of AECOPD
time frame: 10 days
measure: Change of proportion of triggered breaths during the use of NIV at the early onset of AECOPD
time frame: 10 days
measure: Change of proportion of asynchronisms during the use of NIV at the early onset of AECOPD
time frame: 10 days
measure: Change of the number of residual respiratory events during the use of NIV at the early onset of AECOPD
time frame: 10 days
measure: Change of the inspiratory time during the use of NIV at the early onset of AECOPD
time frame: 10 days
measure: Sensitivity and specificity of change in the breathing pattern under NIV to detect an AECOPD
time frame: 10 days
measure: Correlation between the change in symptoms and in the breathing pattern under NIV
time frame: 10 days
measure: Correlation between the length of the change in the breathing pattern under NIV and the length of inpatient stay
time frame: 10 days
measure: Correlation between the importance of the change in the breathing pattern under NIV and the severity of the AECOPD
time frame: 10 days
arm group label: Control cohort
description: Patient with COPD and home NIV admitted for planned respiratory review and without any sign of exacerbation
arm group label: Exacerbation cohort
description: Patient with COPD and home NIV admitted for acute exacerbation of COPD
arm group label: Outpatient exacerbation
description: Patient with COPD and home NIV admitted for planned respiratory review and with signs of acute exacerbation of COPD but not requiring inpatient management
intervention type: Other
intervention name: Analysis of data from NIV built-in software
description: Analysis of breathing pattern using data obtained from NIV built-in software
arm group label: Control cohort
arm group label: Exacerbation cohort
arm group label: Outpatient exacerbation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maxime Patout, MD
role: Principal Investigator
affiliation: University Hospital, Rouen
last name: Antoine Cuvelier, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Rouen
last name: Sophie Blouet
role: Principal Investigator
affiliation: University Hospital, Rouen
facility: 
country: France
responsible party type: Sponsor
mesh term: Pulmonary Disease, Chronic Obstructive