<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/NCT01679808</url>
  </required_header>
  <id_info>
    <org_study_id>GK-18</org_study_id>
    <secondary_id>s-04058c</secondary_id>
    <nct_id>NCT01679808</nct_id>
  </id_info>
  <brief_title>Pressure Dependent Tracheal Obstruction in Copd Patients</brief_title>
  <acronym>PDTO</acronym>
  <official_title>Pressure Dependent Tracheal Obstruction in Copd Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>LHL Helse</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>LHL Helse</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Background. Do pressure dependent tracheal obstructions (PDTO) often seen during bronchoscopy&#xD;
      in COPD patients affect pulmonary function tests and breathing symptoms? Method. Model study.&#xD;
      A garden hose was compressed from one side to simulate the posterior wall of the trachea&#xD;
      bulging into the lumen. For two obstruction lengths - 3 cm and 12 cm, the hose was&#xD;
      increasingly compressed in eight steps. Resistance was measured at each step for airflows 1&#xD;
      l/s through 9 l/s, and digital photos of the luminal area were taken which were used by a&#xD;
      computer to estimate the cross sectional area reduction and the corresponding distance&#xD;
      between the bulging (posterior)and the opposite (anterior) wall (AP-distance).&#xD;
&#xD;
      Patient study. 104 stable COPD patients studied by pulmonary function tests and bronchoscopy.&#xD;
      The tracheal obstruction was observed during forced expiration and cough, and the cross&#xD;
      sectional area reduction was estimated using the results from the model study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2004</start_date>
  <completion_date type="Actual">August 2011</completion_date>
  <primary_completion_date type="Actual">August 2006</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <enrollment type="Actual">104</enrollment>
  <condition>Tracheobronchomalacia</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients (both sexes) in a pulmonary rehabilitation clinic&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  copd&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  clinical evidence of malignant disease&#xD;
&#xD;
          -  not able to be subjected to bronchoscopy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ivar Ellingsen, Dr med</last_name>
    <role>Principal Investigator</role>
    <affiliation>LHL Helse</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Glittreklinikken</name>
      <address>
        <city>Hakadal</city>
        <state>Akershus</state>
        <zip>1485</zip>
        <country>Norway</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 3, 2012</study_first_submitted>
  <study_first_submitted_qc>September 3, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 6, 2012</study_first_posted>
  <last_update_submitted>September 3, 2012</last_update_submitted>
  <last_update_submitted_qc>September 3, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 6, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>copd</keyword>
  <keyword>airway obstruction</keyword>
  <keyword>Tracheobronchomalacia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Tracheobronchomalacia</mesh_term>
    <mesh_term>Bronchomalacia</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/NCT01679808
org study id: GK-18
secondary id: s-04058c
nct id: NCT01679808
lead sponsor: 
has dmc: Yes
Background. Do pressure dependent tracheal obstructions (PDTO) often seen during bronchoscopy
      in COPD patients affect pulmonary function tests and breathing symptoms? Method. Model study.
      A garden hose was compressed from one side to simulate the posterior wall of the trachea
      bulging into the lumen. For two obstruction lengths - 3 cm and 12 cm, the hose was
      increasingly compressed in eight steps. Resistance was measured at each step for airflows 1
      l/s through 9 l/s, and digital photos of the luminal area were taken which were used by a
      computer to estimate the cross sectional area reduction and the corresponding distance
      between the bulging (posterior)and the opposite (anterior) wall (AP-distance).

      Patient study. 104 stable COPD patients studied by pulmonary function tests and bronchoscopy.
      The tracheal obstruction was observed during forced expiration and cough, and the cross
      sectional area reduction was estimated using the results from the model study.
observational model: Case-Only
time perspective: Cross-Sectional
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Ivar Ellingsen, Dr med
role: Principal Investigator
affiliation: LHL Helse
facility: 
country: Norway
responsible party type: Sponsor
mesh term: Tracheobronchomalacia
mesh term: Bronchomalacia