<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/NCT01713413</url>
  </required_header>
  <id_info>
    <org_study_id>OXYM2012</org_study_id>
    <nct_id>NCT01713413</nct_id>
  </id_info>
  <brief_title>Effects of an Oxymizer on Endurance Time in Patients With Chronic Lung Diseases</brief_title>
  <official_title>Effects of an Oxymizer Versus Conventional Nasal Cannula on Endurance Time in Patients With Chronic Obstructive Pulmonary Disease IV (COPD) or Interstitial Lung Disease (ILD)</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 Oxymizer pendant® is a special oxygen cannula that can be used to supply high flow long&#xD;
      term oxygen therapy. It is compatible with a wide variety of oxygen sources. In a reservoir,&#xD;
      the Oxymizer® stores pure oxygen so that the concentration of inhaled oxygen is increased.&#xD;
&#xD;
      The aim of this study is to investigate the potential benefit of the Oxymizer® with regard to&#xD;
      the blood oxygenation during exercise testing. Given that the &quot;endurance time&quot; is very&#xD;
      sensitive for little changes in exercise capacity, this test will be used to show the&#xD;
      difference between the Oxymizer® and a conventional nasal cannula regarding exercise duration&#xD;
      at 70% of peak Watt and oxygenation.&#xD;
&#xD;
      The tests will be accompanied by blood gas analysis, partial pressure of carbon dioxide and&#xD;
      heart rate.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>February 2012</start_date>
  <completion_date type="Actual">March 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>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between Endurance time with Oxymizer and conventional nasal cannula</measure>
    <time_frame>From starting until stopping cycling, up to 60 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in oxygen saturation with Oxymizer and with conventional nasal cannula</measure>
    <time_frame>stopping cycling, up to 60 minutes</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in PaCO2 with Oxymizer and with conventional nasal cannula</measure>
    <time_frame>Stopping cycling, up to 60 minutes</time_frame>
    <description>measured by Sentec device</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">67</enrollment>
  <condition>COPD</condition>
  <condition>Interstitial Lung Disease</condition>
  <arm_group>
    <arm_group_label>Oxymizer</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using first the Oxymizer and 24 h later the conventional nasal cannula.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>nasal cannula</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Using first the conventional nasal cannula and 24 h later the Oxymizer</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Oxymizer</intervention_name>
    <description>Using first the Oxymizer and 24 h later the conventional nasal cannula.</description>
    <arm_group_label>Oxymizer</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>conventional nasal cannula</intervention_name>
    <description>Using first the conventional nasal cannula and 24h later the Oxymizer</description>
    <arm_group_label>nasal cannula</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD IV&#xD;
&#xD;
          -  interstitial lung disease&#xD;
&#xD;
          -  long-term oxygen therapy with oxygen flow rate &gt;= 2 L/min&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute cardial decompensation&#xD;
&#xD;
          -  usual kontraindication for exposure test (higher-grad Hypertension (arterial and&#xD;
             pulmonal), cardiac valve vitien, instabile angina pectoris, cardiac arrhythmia)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Klinikum Berchtesgadener Land</name>
      <address>
        <city>Berchtesgaden</city>
        <state>Bavaria</state>
        <zip>83714</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>April 2014</verification_date>
  <study_first_submitted>February 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 22, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 24, 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>Oxymizer</keyword>
  <keyword>endurance time</keyword>
  <keyword>exercise test</keyword>
  <keyword>nasal cannula</keyword>
  <keyword>COPD</keyword>
  <keyword>ILD</keyword>
  <keyword>oxygenation</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lung Diseases</mesh_term>
    <mesh_term>Lung Diseases, Interstitial</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/NCT01713413
org study id: OXYM2012
nct id: NCT01713413
lead sponsor: 
has dmc: No
The Oxymizer pendant® is a special oxygen cannula that can be used to supply high flow long
      term oxygen therapy. It is compatible with a wide variety of oxygen sources. In a reservoir,
      the Oxymizer® stores pure oxygen so that the concentration of inhaled oxygen is increased.

      The aim of this study is to investigate the potential benefit of the Oxymizer® with regard to
      the blood oxygenation during exercise testing. Given that the "endurance time" is very
      sensitive for little changes in exercise capacity, this test will be used to show the
      difference between the Oxymizer® and a conventional nasal cannula regarding exercise duration
      at 70% of peak Watt and oxygenation.

      The tests will be accompanied by blood gas analysis, partial pressure of carbon dioxide and
      heart rate.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Difference between Endurance time with Oxymizer and conventional nasal cannula
time frame: From starting until stopping cycling, up to 60 minutes
measure: Difference in oxygen saturation with Oxymizer and with conventional nasal cannula
time frame: stopping cycling, up to 60 minutes
measure: Difference in PaCO2 with Oxymizer and with conventional nasal cannula
time frame: Stopping cycling, up to 60 minutes
description: measured by Sentec device
arm group label: Oxymizer
arm group type: Active Comparator
description: Using first the Oxymizer and 24 h later the conventional nasal cannula.
arm group label: nasal cannula
arm group type: Active Comparator
description: Using first the conventional nasal cannula and 24 h later the Oxymizer
intervention type: Device
intervention name: Oxymizer
description: Using first the Oxymizer and 24 h later the conventional nasal cannula.
arm group label: Oxymizer
intervention type: Device
intervention name: conventional nasal cannula
description: Using first the conventional nasal cannula and 24h later the Oxymizer
arm group label: nasal cannula
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
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, Interstitial