<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/NCT01696916</url>
  </required_header>
  <id_info>
    <org_study_id>Sentec2012</org_study_id>
    <nct_id>NCT01696916</nct_id>
  </id_info>
  <brief_title>Development of the Partial Pressure of Carbon Dioxide During Exercise and at Night in Patients With Chronic Obstructive Pulmonary Disease (COPD) IV</brief_title>
  <official_title>Development of the Partial Pressure of Carbon Dioxide During 6-min Walking Test and at Night in Patients With Chronic Obstructive Pulmonary Disease IV</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Schön Klinik Berchtesgadener Land</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Schön Klinik Berchtesgadener Land</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to investigate the development of partial pressure of carbon dioxide&#xD;
      during the 6-min walking test and during night in Chronic Obstructive Pulmonary Disease&#xD;
      (COPD)-patients (GOLD stage IV). Therefore the partial pressure of carbon dioxide, oxygen&#xD;
      saturation and the heart rate are registered by a device called &quot;Sentec&quot; during the mentioned&#xD;
      periods. In addition a measurement of activity is realised by an activity monitor&#xD;
      (&quot;Sensewear&quot;).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 2014</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Increase of PaCO2 more than 5mmHg</measure>
    <time_frame>From time of starting 6-minute walking test until the time of PaCO2-increase of more than 5mmHg assessed up to 6 minutes.</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of PaCO2</measure>
    <time_frame>From the beginning of the 6-minute walking test until peak PaCO2, assessed up to 6 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Chronic Obstructive Pulmonary Disease</condition>
  <arm_group>
    <arm_group_label>exercise testing</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>6-minute walking test with pCO2 and pO2 measurement</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>6-minute walking test</intervention_name>
    <description>submaximum exercise test</description>
    <arm_group_label>exercise testing</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD IV with and without a respiratory insufficiency&#xD;
&#xD;
          -  maximal paCO² of 55mmHg at admission (taken at rest by blood gas analysis without&#xD;
             LTOT)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  paCO² &gt; 55mmHg&#xD;
&#xD;
          -  non-invasive ventilation&#xD;
&#xD;
          -  acute exacerbation&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Klaus Kenn, Dr. med.</last_name>
    <role>Study Chair</role>
    <affiliation>Klinikum Berchtesgadener Land, Schön Klinik</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Klinikum Berchtesgadener Land</name>
      <address>
        <city>Berchtesgaden</city>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>February 21, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>April 14, 2014</last_update_submitted>
  <last_update_submitted_qc>April 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">April 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Schön Klinik Berchtesgadener Land</investigator_affiliation>
    <investigator_full_name>Klaus Kenn</investigator_full_name>
    <investigator_title>Head physician (department of pneumology)</investigator_title>
  </responsible_party>
  <keyword>COPD</keyword>
  <keyword>carbon dioxide</keyword>
  <keyword>6-minute walking test</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <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/NCT01696916
org study id: Sentec2012
nct id: NCT01696916
lead sponsor: 
has dmc: No
The aim of this study is to investigate the development of partial pressure of carbon dioxide
      during the 6-min walking test and during night in Chronic Obstructive Pulmonary Disease
      (COPD)-patients (GOLD stage IV). Therefore the partial pressure of carbon dioxide, oxygen
      saturation and the heart rate are registered by a device called "Sentec" during the mentioned
      periods. In addition a measurement of activity is realised by an activity monitor
      ("Sensewear").
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Increase of PaCO2 more than 5mmHg
time frame: From time of starting 6-minute walking test until the time of PaCO2-increase of more than 5mmHg assessed up to 6 minutes.
measure: Change of PaCO2
time frame: From the beginning of the 6-minute walking test until peak PaCO2, assessed up to 6 minutes
arm group label: exercise testing
arm group type: Experimental
description: 6-minute walking test with pCO2 and pO2 measurement
intervention type: Procedure
intervention name: 6-minute walking test
description: submaximum exercise test
arm group label: exercise testing
criteria: 
gender: All
minimum age: 30 Years
maximum age: 75 Years
healthy volunteers: No
last name: Klaus Kenn, Dr. med.
role: Study Chair
affiliation: Klinikum Berchtesgadener Land, Schön Klinik
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Schön Klinik Berchtesgadener Land
investigator full name: Klaus Kenn
investigator title: Head physician (department of pneumology)
mesh term: Lung Diseases
mesh term: Lung Diseases, Obstructive
mesh term: Pulmonary Disease, Chronic Obstructive