<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/NCT01693146</url>
  </required_header>
  <id_info>
    <org_study_id>UN4484</org_study_id>
    <secondary_id>UN4484</secondary_id>
    <nct_id>NCT01693146</nct_id>
  </id_info>
  <brief_title>STIT-2: Evaluation of Safety and Efficacy of Short-time TNI® Treatment in Patients With COPD and Hypercapnia</brief_title>
  <acronym>STIT-2</acronym>
  <official_title>Evaluation of Safety and Efficacy of Short-time TNI® Treatment in Patients With COPD and Hypercapnia Acute Testing of Oxygen Demand Using TNI® vs. Standard Insufflation in COPD Patients With Hypercapnia at Rest</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>TNI Medical AG</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Medical University Innsbruck</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of Safety and Efficacy of Short time TNI Treatment in Patients with COPD and&#xD;
      hypercapnia.&#xD;
&#xD;
      Acute testing of oxygen demand using TNI vs. standard oxygen application in stable COPD&#xD;
      patients with hypercapnia.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      TNI, the nasal insufflation of a high flow of warm, humidified air, is an extremely&#xD;
      comfortable and uncomplicated alternative to numerous other approaches in non-invasive&#xD;
      ventilation (NIV). Up to now, NIV therapy could only be applied by masks with the associated&#xD;
      complications as patients could not tolerate high airflow delivered by a thin nasal cannula&#xD;
      without humidification and warming, thus causing concomitant negative effects. The new&#xD;
      therapy TNI shows a high rate of acceptance by children, too.&#xD;
&#xD;
      At present, there are two different types of devices available for nasal insufflation in&#xD;
      clinics:&#xD;
&#xD;
      TNI 20s, an air humidifier for clinical compressed air, and the TNI20 oxy, an air humidifier&#xD;
      for clinical compressed air, which can be combined with oxygen.&#xD;
&#xD;
      TNI 20 oxy The system, which is unique throughout the world, is optimized for the application&#xD;
      of flows of up to 20L/min and fulfils the minimum requirements of the &quot;American Society of&#xD;
      Testing and Materials&quot; for a high flow air humidifier in the non-invasive application of 10&#xD;
      mg H2O/L (equivalent to about 60% rel. humidity at an ambient temperature of 22°C) for the&#xD;
      air humidity. The warming of the air flow by 5-15°C can be adjusted relative to the ambient&#xD;
      temperature. Condensation is prevented in the nasal applicator by heating the tube as far as&#xD;
      the nostrils. The device automatically controls humidity and temperature depending on the&#xD;
      prevailing ambient conditions. The TNI®20s can be attached to the hospital infrastructure by&#xD;
      means of a standard pressure regulator.&#xD;
&#xD;
      In another ongoing study (STIT-1) TNI 20 oxy was evaluated for its safety in COPD patients&#xD;
      without hypercapnia. In a first interim analysis which included 14 patients high flow oxygen&#xD;
      delivery was safe.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>December 2011</start_date>
  <completion_date type="Anticipated">December 2013</completion_date>
  <primary_completion_date type="Anticipated">December 2013</primary_completion_date>
  <phase>Phase 1</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PaO2</measure>
    <time_frame>60 min</time_frame>
    <description>Change in the partial oxygen pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>O2%</measure>
    <time_frame>60 min</time_frame>
    <description>Change in the oxygen saturation in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PaCO2</measure>
    <time_frame>60 min</time_frame>
    <description>Change in the PaCO2 in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>AaDO2</measure>
    <time_frame>60 min</time_frame>
    <description>Change in the AaDO2 in the peripheral blood at a defined oxygen flow rate (L/min)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>RV and TLC</measure>
    <time_frame>60 min</time_frame>
    <description>No increase in the residual volume (RV) and the total lung capacity (TLC) &gt; 15% of the mean actual value at visits 1 and 2 (measurement 60 + 10 minutes after oxygen insufflation with a TNI system).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>COPD</condition>
  <condition>Hypercapnia</condition>
  <arm_group>
    <arm_group_label>Nasal insufflation of oxygen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Nasal insufflation of oxygen starting at at flow of 0.5 L/min.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nasal oxygen insufflation with a TNI® 20 oxy device</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Device: TNI®20 oxy Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasal oxygen insufflation with a TNI® 20 oxy device</intervention_name>
    <description>Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min</description>
    <arm_group_label>Nasal oxygen insufflation with a TNI® 20 oxy device</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasal insufflation of oxygen</intervention_name>
    <description>Nasal insufflation of oxygen starting at at flow of 0.5 L/min.</description>
    <arm_group_label>Nasal insufflation of oxygen</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD patients with an indication for long-term oxygen therapy (LTOT)&#xD;
&#xD;
          -  Presence of hypercapnia at rest without oxygen supplementation (PaCO2 &gt; 45 mmHg)&#xD;
&#xD;
          -  Age 30 - 85 years&#xD;
&#xD;
          -  Functional GOLD class: COPD GOLD IV as defined by the following:&#xD;
&#xD;
        FEV1/FVC &lt; 70% and a Post-bronchodilator FEV1 &lt; 30% or FEV1 &lt; 50% and a PaO2 &lt; 60 mmHg&#xD;
        and/or PaCO2 &gt; 50 mmHg&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinical instability of the patient&#xD;
&#xD;
          -  No lung function testing possible&#xD;
&#xD;
          -  Exacerbation within the last 14 days prior to inclusion into the study&#xD;
&#xD;
          -  Serious concomitant diseases that may jeopardize the inclusion of the patient into the&#xD;
             study from the investigator's point of view&#xD;
&#xD;
          -  Severe anaemia, defined by a haemoglobin &lt;8.5 G/L&#xD;
&#xD;
          -  Participation of the patient in any other ongoing study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian M Kaehler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Medical University Innsbruck</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Christian M Kaehler, MD</last_name>
    <phone>004351250423255</phone>
    <email>c.m.kaehler@i-med.ac.at</email>
  </overall_contact>
  <location>
    <facility>
      <name>Christian Kähler</name>
      <address>
        <city>Innsbruck</city>
        <zip>A-6020</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Christian M Kaehler, MD</last_name>
      <phone>004351250423255</phone>
      <email>c.m.kaehler@i-med.ac.at</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Pneumologie, Medizinische Klinik und Poliklinik I, University of Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>D-01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Michael Halank, MD</last_name>
      <phone>0049 351 458 - 4721</phone>
    </contact>
    <investigator>
      <last_name>Gert Höffken, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Klinik für Innere Medizin V, Universitätsklinikum Homburg, University of Homburg/Saar</name>
      <address>
        <city>Homburg</city>
        <zip>D-66424</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Heinrike Wilkens, MD</last_name>
      <phone>0049 6841 16-23633</phone>
    </contact>
  </location>
  <location>
    <facility>
      <name>Klinik und Poliklinik für Pneumologie, Inselspital Berne, University of Berne</name>
      <address>
        <city>Berne</city>
        <zip>CH-3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Thomas Geiser, MD</last_name>
      <phone>0031 632 34 90</phone>
    </contact>
  </location>
  <location_countries>
    <country>Austria</country>
    <country>Germany</country>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 14, 2012</study_first_submitted>
  <study_first_submitted_qc>September 25, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 26, 2012</study_first_posted>
  <last_update_submitted>September 25, 2012</last_update_submitted>
  <last_update_submitted_qc>September 25, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 26, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Medical University Innsbruck</investigator_affiliation>
    <investigator_full_name>Univ.-Prof. Dr. Christian M. Kaehler</investigator_full_name>
    <investigator_title>a.Univ.-Prod. Dr.</investigator_title>
  </responsible_party>
  <keyword>Oxygen</keyword>
  <keyword>High Flow</keyword>
  <keyword>COPD</keyword>
  <keyword>Hypercapnia</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hypercapnia</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/NCT01693146
org study id: UN4484
secondary id: UN4484
nct id: NCT01693146
lead sponsor: 
collaborator: 
has dmc: No
Evaluation of Safety and Efficacy of Short time TNI Treatment in Patients with COPD and
      hypercapnia.

      Acute testing of oxygen demand using TNI vs. standard oxygen application in stable COPD
      patients with hypercapnia.
TNI, the nasal insufflation of a high flow of warm, humidified air, is an extremely
      comfortable and uncomplicated alternative to numerous other approaches in non-invasive
      ventilation (NIV). Up to now, NIV therapy could only be applied by masks with the associated
      complications as patients could not tolerate high airflow delivered by a thin nasal cannula
      without humidification and warming, thus causing concomitant negative effects. The new
      therapy TNI shows a high rate of acceptance by children, too.

      At present, there are two different types of devices available for nasal insufflation in
      clinics:

      TNI 20s, an air humidifier for clinical compressed air, and the TNI20 oxy, an air humidifier
      for clinical compressed air, which can be combined with oxygen.

      TNI 20 oxy The system, which is unique throughout the world, is optimized for the application
      of flows of up to 20L/min and fulfils the minimum requirements of the "American Society of
      Testing and Materials" for a high flow air humidifier in the non-invasive application of 10
      mg H2O/L (equivalent to about 60% rel. humidity at an ambient temperature of 22°C) for the
      air humidity. The warming of the air flow by 5-15°C can be adjusted relative to the ambient
      temperature. Condensation is prevented in the nasal applicator by heating the tube as far as
      the nostrils. The device automatically controls humidity and temperature depending on the
      prevailing ambient conditions. The TNI®20s can be attached to the hospital infrastructure by
      means of a standard pressure regulator.

      In another ongoing study (STIT-1) TNI 20 oxy was evaluated for its safety in COPD patients
      without hypercapnia. In a first interim analysis which included 14 patients high flow oxygen
      delivery was safe.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: PaO2
time frame: 60 min
description: Change in the partial oxygen pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
measure: O2%
time frame: 60 min
description: Change in the oxygen saturation in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
measure: PaCO2
time frame: 60 min
description: Change in the PaCO2 in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
measure: AaDO2
time frame: 60 min
description: Change in the AaDO2 in the peripheral blood at a defined oxygen flow rate (L/min)
measure: RV and TLC
time frame: 60 min
description: No increase in the residual volume (RV) and the total lung capacity (TLC) > 15% of the mean actual value at visits 1 and 2 (measurement 60 + 10 minutes after oxygen insufflation with a TNI system).
arm group label: Nasal insufflation of oxygen
arm group type: Active Comparator
description: Nasal insufflation of oxygen starting at at flow of 0.5 L/min.
arm group label: Nasal oxygen insufflation with a TNI® 20 oxy device
arm group type: Active Comparator
description: Device: TNI®20 oxy Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min
intervention type: Device
intervention name: Nasal oxygen insufflation with a TNI® 20 oxy device
description: Nasal insufflation at a constant high flow of 15 L/min with oxygen addition starting at 0.5 L/min
arm group label: Nasal oxygen insufflation with a TNI® 20 oxy device
intervention type: Device
intervention name: Nasal insufflation of oxygen
description: Nasal insufflation of oxygen starting at at flow of 0.5 L/min.
arm group label: Nasal insufflation of oxygen
criteria: 
gender: All
minimum age: 30 Years
maximum age: 85 Years
healthy volunteers: No
last name: Christian M Kaehler, MD
role: Principal Investigator
affiliation: Medical University Innsbruck
last name: Christian M Kaehler, MD
phone: 004351250423255
email: c.m.kaehler@i-med.ac.at
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
investigator: 
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Austria
country: Germany
country: Switzerland
responsible party type: Principal Investigator
investigator affiliation: Medical University Innsbruck
investigator full name: Univ.-Prof. Dr. Christian M. Kaehler
investigator title: a.Univ.-Prod. Dr.
mesh term: Hypercapnia