<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/NCT03012737</url>
  </required_header>
  <id_info>
    <org_study_id>R16111</org_study_id>
    <nct_id>NCT03012737</nct_id>
  </id_info>
  <brief_title>Palliation of Dyspnea With Mouth Piece Ventilation</brief_title>
  <official_title>Palliation of Dyspnea With Mouth Piece Ventilation</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 incurable advanced disease. Subjects are recruited from a local Hospice and&#xD;
      from oncology ward. The main outcomes are the compliance of the subjects with the treatment&#xD;
      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 1, 2017</start_date>
  <completion_date type="Actual">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">December 1, 2019</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in dyspnea after initial use of MPV</measure>
    <time_frame>5 - 60 min</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in dyspnea after 24 hours of using MPV</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects having side-effects or not being compliant with MPV</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects gaining from MPV</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of subjects willing to continue on MPV after the intervention</measure>
    <time_frame>24 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">22</enrollment>
  <condition>Dyspnea</condition>
  <arm_group>
    <arm_group_label>MPV arm</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Subjects use mouth piece ventilation (MPV) accoring to their will to alleviate dyspnea for 24 hours.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Trilogy 100 ® (Philips Respironics)</intervention_name>
    <description>Trilogy 100 ® (Philips Respironics) on MPV mode.</description>
    <arm_group_label>MPV arm</arm_group_label>
    <other_name>Mouth piece ventilation</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least moderate dyspnea (NRS = Numeric Rating Scale ≥ 4)&#xD;
&#xD;
          -  incurable advanced disease&#xD;
&#xD;
          -  able to understand the study and to give informed consent&#xD;
&#xD;
          -  would not gain from intensive care or resuscitation according to the treating&#xD;
             physician&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  unable to participate and use MPV due to e.g. delirium or lack of co-operation&#xD;
&#xD;
          -  the cause of the dyspnea can be succesfully treated&#xD;
&#xD;
          -  unable to give informed consent&#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</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Dpt of oncology, Tampere University Hospital</name>
      <address>
        <city>Tampere</city>
        <zip>33520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pirkanmaa Hospice</name>
      <address>
        <city>Tampere</city>
        <zip>33520</zip>
        <country>Finland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Finland</country>
  </location_countries>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>October 6, 2020</last_update_submitted>
  <last_update_submitted_qc>October 6, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 8, 2020</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>
  <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/NCT03012737
org study id: R16111
nct id: NCT03012737
lead sponsor: 
has dmc: No
An uncontrolled feasibility study on using mouth piece ventilation in palliation of dyspnea
      in subjects with incurable advanced disease. Subjects are recruited from a local Hospice and
      from oncology 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: Supportive Care
masking: None (Open Label)
measure: Change in dyspnea after initial use of MPV
time frame: 5 - 60 min
measure: Change in dyspnea after 24 hours of using MPV
time frame: 24 hours
measure: Proportion of subjects having side-effects or not being compliant with MPV
time frame: 24 hours
measure: Proportion of subjects gaining from MPV
time frame: 24 hours
measure: Proportion of subjects willing to continue on MPV after the intervention
time frame: 24 hours
arm group label: MPV arm
arm group type: Other
description: Subjects use mouth piece ventilation (MPV) accoring to their will to alleviate dyspnea for 24 hours.
intervention type: Device
intervention name: Trilogy 100 ® (Philips Respironics)
description: Trilogy 100 ® (Philips Respironics) on MPV mode.
arm group label: MPV arm
other name: Mouth piece ventilation
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
facility: 
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
sharing ipd: No