<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/NCT01671540</url>
  </required_header>
  <id_info>
    <org_study_id>PML_Kine_IPV</org_study_id>
    <secondary_id>artesis_G018</secondary_id>
    <nct_id>NCT01671540</nct_id>
  </id_info>
  <brief_title>Effects of IPV Assessed With Functional Imaging</brief_title>
  <acronym>IPV</acronym>
  <official_title>Evaluation of the Effects of Intrapulmonary Percussive Ventilation Using Functional Respiratory Imaging</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Antwerp</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Artesis University College, Antwerp</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>FLUIDDA nv</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Antwerp</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study the invetigators seek an answer on the following hypothesis:&#xD;
&#xD;
        -  What are the long term effects of an IPV treatment evaluated with classical outcome&#xD;
           parameters? (FEV1, Raw)&#xD;
&#xD;
        -  Is the possible effect noticeable on the novel technique and is this comparable with the&#xD;
           classical outcome parameters?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A Multicenter study conducted in university Hospital Antwerp (UZA) and ZNA Middelheim.&#xD;
&#xD;
      Tests are taken before and after one week IPV treatment. IPV is applied for 1 week during the&#xD;
      physical therapy treatment of chronic obstructive pulmonary desease (COPD) patients admitted&#xD;
      to the hospital for an excarebation. The IPV treatment is an additional treatment upon the&#xD;
      standard treatment of the patients. The standard treatment consists out of existing drainage&#xD;
      techniques to remove secretion out of the lungs by means of breathing control exercises.&#xD;
      Patients are randomized into either the experimental group or the control group. The control&#xD;
      group receives a standard physical therapy treatment without additional IPV treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2011</start_date>
  <primary_completion_date type="Anticipated">December 2015</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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Lung function testing</measure>
    <time_frame>baseline and after one week</time_frame>
    <description>(spirometric , bodybox en diffusion) Performed in the lung function laboratory according to ERS standards using Jaeger 5.1 device vital capacity (VC), FEV1, FEV1/VC, peak expiratory flow (PEF), MMEF 75/25, MEF 50, MEF 25, MIF 50, RV, total lung capacity (TLC), functionale residual capacity (FRC), resistance, spec resistance, TCO, alveolar volume (VA), TCO/VA, Maximal inspiratory pressure, Maximal expiratory pressure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>functional respiratory imaging</measure>
    <time_frame>at baseline and after one week</time_frame>
    <description>A 3D CT-scan is take. Images are uploaded into a software program for post processing 3D images are made and images are post processed</description>
  </secondary_outcome>
  <other_outcome>
    <measure>questionnaires</measure>
    <time_frame>1 week</time_frame>
    <description>St george Borg MRC</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>Intrapulmonary percussive ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>IPV is applied for 1 week (once a day) during the physical therapy treatment of the patient</description>
  </arm_group>
  <arm_group>
    <arm_group_label>standard airwy claerance regime</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The standard treatment consists out of existing drainage techniques to remove secretion out of the lungs by means of breathing control exercises</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>intrapulmonary percussive ventilation</intervention_name>
    <arm_group_label>Intrapulmonary percussive ventilation</arm_group_label>
    <other_name>IMP 2 by Breas Sweden</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard treatment</intervention_name>
    <description>breathing control exercises</description>
    <arm_group_label>standard airwy claerance regime</arm_group_label>
    <other_name>Autogenic drainge</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients admitted in the hospital for a acute exacerbation&#xD;
&#xD;
          -  Mild to severe COPD&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ischemic / ventricular aritmic&#xD;
&#xD;
          -  Tracheotomise&#xD;
&#xD;
          -  Pneumothorax&#xD;
&#xD;
          -  Facial deformity&#xD;
&#xD;
          -  Recent nose, mouth or ear operations&#xD;
&#xD;
          -  Recent gastric operations.&#xD;
&#xD;
          -  Intubated&#xD;
&#xD;
          -  Epilepsy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Wilfried De Backer, Phd</last_name>
    <role>Principal Investigator</role>
    <affiliation>UZA pneumology</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kris Ides, Msc</last_name>
    <phone>036418267</phone>
    <email>kris.ides@artesis.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>University Hospital Antwerp</name>
      <address>
        <city>Edegem</city>
        <state>Antwerp</state>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kris Ides, Msc</last_name>
      <phone>038213447</phone>
      <phone_ext>0032</phone_ext>
      <email>kris.ides@artesis.be</email>
    </contact>
    <investigator>
      <last_name>Wilfried De Backer, Phd</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>August 20, 2012</study_first_submitted>
  <study_first_submitted_qc>August 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 23, 2012</study_first_posted>
  <last_update_submitted>May 27, 2015</last_update_submitted>
  <last_update_submitted_qc>May 27, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 28, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Hospital, Antwerp</investigator_affiliation>
    <investigator_full_name>Wilfried De Backer</investigator_full_name>
    <investigator_title>Prof. Dr.</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>IPV</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases, Obstructive</mesh_term>
    <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/NCT01671540
org study id: PML_Kine_IPV
secondary id: artesis_G018
nct id: NCT01671540
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
In this study the invetigators seek an answer on the following hypothesis:

        -  What are the long term effects of an IPV treatment evaluated with classical outcome
           parameters? (FEV1, Raw)

        -  Is the possible effect noticeable on the novel technique and is this comparable with the
           classical outcome parameters?
A Multicenter study conducted in university Hospital Antwerp (UZA) and ZNA Middelheim.

      Tests are taken before and after one week IPV treatment. IPV is applied for 1 week during the
      physical therapy treatment of chronic obstructive pulmonary desease (COPD) patients admitted
      to the hospital for an excarebation. The IPV treatment is an additional treatment upon the
      standard treatment of the patients. The standard treatment consists out of existing drainage
      techniques to remove secretion out of the lungs by means of breathing control exercises.
      Patients are randomized into either the experimental group or the control group. The control
      group receives a standard physical therapy treatment without additional IPV treatment.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
measure: Lung function testing
time frame: baseline and after one week
description: (spirometric , bodybox en diffusion) Performed in the lung function laboratory according to ERS standards using Jaeger 5.1 device vital capacity (VC), FEV1, FEV1/VC, peak expiratory flow (PEF), MMEF 75/25, MEF 50, MEF 25, MIF 50, RV, total lung capacity (TLC), functionale residual capacity (FRC), resistance, spec resistance, TCO, alveolar volume (VA), TCO/VA, Maximal inspiratory pressure, Maximal expiratory pressure
measure: functional respiratory imaging
time frame: at baseline and after one week
description: A 3D CT-scan is take. Images are uploaded into a software program for post processing 3D images are made and images are post processed
measure: questionnaires
time frame: 1 week
description: St george Borg MRC
arm group label: Intrapulmonary percussive ventilation
arm group type: Experimental
description: IPV is applied for 1 week (once a day) during the physical therapy treatment of the patient
arm group label: standard airwy claerance regime
arm group type: Active Comparator
description: The standard treatment consists out of existing drainage techniques to remove secretion out of the lungs by means of breathing control exercises
intervention type: Device
intervention name: intrapulmonary percussive ventilation
arm group label: Intrapulmonary percussive ventilation
other name: IMP 2 by Breas Sweden
intervention type: Other
intervention name: standard treatment
description: breathing control exercises
arm group label: standard airwy claerance regime
other name: Autogenic drainge
criteria: 
gender: All
minimum age: 30 Years
maximum age: N/A
healthy volunteers: No
last name: Wilfried De Backer, Phd
role: Principal Investigator
affiliation: UZA pneumology
last name: Kris Ides, Msc
phone: 036418267
email: kris.ides@artesis.be
facility: 
status: Recruiting
contact: 
investigator: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: University Hospital, Antwerp
investigator full name: Wilfried De Backer
investigator title: Prof. Dr.
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive