<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/NCT03025425</url>
  </required_header>
  <id_info>
    <org_study_id>R16148_TAYS</org_study_id>
    <nct_id>NCT03025425</nct_id>
  </id_info>
  <brief_title>Palliation of Dyspnea With Mouth Piece Ventilation in AECOPD</brief_title>
  <official_title>Palliation of Dyspnea With Mouth Piece Ventilation in Acute Exacerbation of COPD Without Respiratory Insufficiency</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Tampere University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Tampere University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea&#xD;
      in subjects with acute exacerbation of COPD without acute hypercapnic respiratory failure.&#xD;
      Subjects are recruited from the local respiratory ward. The main outcomes are the compliance&#xD;
      of the subjects with the treatment and alleviation of dyspnea during the treatment period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Difficulty in finding suitable patients&#xD;
  </why_stopped>
  <start_date type="Actual">January 2017</start_date>
  <completion_date type="Actual">August 1, 2020</completion_date>
  <primary_completion_date type="Actual">August 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>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in dyspnea after initial period of using MPV</measure>
    <time_frame>5-60 min</time_frame>
    <description>Change in dyspnea after initial period of using MPV</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in dyspnea after 24 hours of using MPV</measure>
    <time_frame>24 hours</time_frame>
    <description>Change in dyspnea after 24 hours of using MPV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects having side-effects or not being compliant with MPV</measure>
    <time_frame>24 hours</time_frame>
    <description>Proportion of subjects having side-effects or not being compliant with MPV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects gaining from MPV</measure>
    <time_frame>24 hours</time_frame>
    <description>Proportion of subjects gaining from MPV</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects willing to continue on MPV after the intervention</measure>
    <time_frame>24 hours</time_frame>
    <description>Proportion of subjects willing to continue on MPV after the intervention</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>COPD Exacerbation</condition>
  <condition>Dyspnea</condition>
  <arm_group>
    <arm_group_label>MPV-arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Subjects use mouth piece ventilation (MPV) according to their will for 24 hours to alleviate dyspnea.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Trilogy 100 ® (Philips Respironics)</intervention_name>
    <description>Mouth piece Ventilation (MPV) using Trilogy 100 ® (Philips Respironics).</description>
    <arm_group_label>MPV-arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  a previous diagnosis of COPD&#xD;
&#xD;
          -  hospitalized due to acute exacerbation of COPD&#xD;
&#xD;
          -  at least moderate dyspnea (NRS = Numeric Rating Scale ≥ 4)&#xD;
&#xD;
          -  no acute hypoventilation (pH ≥ 7.35 and PCO2 ≤ 6.0 kPa)&#xD;
&#xD;
          -  able to understand the study and to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to participate and use MPV due to e.g. delirium or lack of co-operation&#xD;
&#xD;
          -  acute hypoventilation (pH &lt; 7.35 or PCO2 &gt; 6.0 kPa)&#xD;
&#xD;
          -  acute need for ventilatory support&#xD;
&#xD;
          -  the cause of the dyspnea can be successfully treated&#xD;
&#xD;
          -  unable to give informed consent&#xD;
&#xD;
          -  a previous chronic hypoxemic or hypercapnic respiratory insufficiency that has been&#xD;
             treated on a long-term basis also at home&#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>Lauri Lehtimäki, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Tampere University Hospital, Allergy centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dpt of Respiratory Medicine, Tampere University Hospital</name>
      <address>
        <city>Tampere</city>
        <zip>33520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>October 2021</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 17, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>October 18, 2021</last_update_submitted>
  <last_update_submitted_qc>October 18, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">October 26, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Tampere University Hospital</investigator_affiliation>
    <investigator_full_name>Lauri Lehtimäki</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dyspnea</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/NCT03025425
org study id: R16148_TAYS
nct id: NCT03025425
lead sponsor: 
has dmc: No
An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea
      in subjects with acute exacerbation of COPD without acute hypercapnic respiratory failure.
      Subjects are recruited from the local respiratory ward. The main outcomes are the compliance
      of the subjects with the treatment and alleviation of dyspnea during the treatment period.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in dyspnea after initial period of using MPV
time frame: 5-60 min
description: Change in dyspnea after initial period of using MPV
measure: Change in dyspnea after 24 hours of using MPV
time frame: 24 hours
description: Change in dyspnea after 24 hours of using MPV
measure: Proportion of subjects having side-effects or not being compliant with MPV
time frame: 24 hours
description: Proportion of subjects having side-effects or not being compliant with MPV
measure: Proportion of subjects gaining from MPV
time frame: 24 hours
description: Proportion of subjects gaining from MPV
measure: Proportion of subjects willing to continue on MPV after the intervention
time frame: 24 hours
description: Proportion of subjects willing to continue on MPV after the intervention
arm group label: MPV-arm
arm group type: Experimental
description: Subjects use mouth piece ventilation (MPV) according to their will for 24 hours to alleviate dyspnea.
intervention type: Device
intervention name: Trilogy 100 ® (Philips Respironics)
description: Mouth piece Ventilation (MPV) using Trilogy 100 ® (Philips Respironics).
arm group label: MPV-arm
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Lauri Lehtimäki, MD
role: Principal Investigator
affiliation: Tampere University Hospital, Allergy centre
facility: 
country: Finland
responsible party type: Principal Investigator
investigator affiliation: Tampere University Hospital
investigator full name: Lauri Lehtimäki
investigator title: Associate Professor
mesh term: Dyspnea