<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/NCT01686893</url>
  </required_header>
  <id_info>
    <org_study_id>AN3547</org_study_id>
    <secondary_id>AN 3546</secondary_id>
    <nct_id>NCT01686893</nct_id>
  </id_info>
  <brief_title>Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD</brief_title>
  <acronym>STIT-1</acronym>
  <official_title>STIT-1 Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients With COPD</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Medical University Innsbruck</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Medical University Innsbruck</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients with COPD Acute&#xD;
      testing of oxygen demand using TNI vs. standard oxygen application in stable COPD patients An&#xD;
      investigator-initiated, prospective, controlled, multicenter study&#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;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2009</start_date>
  <completion_date type="Anticipated">March 2013</completion_date>
  <primary_completion_date type="Anticipated">February 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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PaO2</measure>
    <time_frame>Measures at Baseline and after 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>Measures at Baseline and after 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>Measures at Baseline and after 60 min</time_frame>
    <description>Change in the partial carbon dioxide pressure 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>Measures at Baseline and after 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>Measures at Baseline and after 60 min</time_frame>
    <description>Safety of the device in COPD °III or IV patients:&#xD;
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">50</enrollment>
  <condition>Oxygen Inhalation Therapy</condition>
  <arm_group>
    <arm_group_label>Standard Nasal Insufflation of oxygen</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard Nasal Insufflation of oxygen</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>Nasal oxygen insufflation with a TNI 20 oxy device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Nasal oxygen insufflation with a TNI 20 oxy device</intervention_name>
    <description>Nasal oxygen insufflation with a TNI 20 oxy device</description>
    <arm_group_label>Nasal oxygen insufflation with a TNI 20 oxy device</arm_group_label>
    <other_name>TNI 20 oxy</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Standard Nasal Insufflation of oxygen</intervention_name>
    <description>Standard Nasal Insufflation of oxygen</description>
    <arm_group_label>Standard 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 Age 30 - 80 years COPD GOLD&#xD;
        °III&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - Clinical instability of the patient No lung function testing possible Exacerbation within&#xD;
        the last 14 days prior to inclusion into the study Serious concomitant diseases that may&#xD;
        jeopardize the inclusion of the patient into the study from the investigator's point of&#xD;
        view Anaemia, defined by a haemoglobin &lt;10 G/L Patients with hypercapnia, defined by a paCO&#xD;
        &lt;46mmHg Participation of the patient in any other ongoing study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian M Kaehler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Pneumology, 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>Pneumology/USPH Innsbruck, Medical University Innsbruck</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 Dresden</name>
      <address>
        <city>Dresden</city>
        <zip>D-01307</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>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>Sub-Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Klinik und Poliklinik für Pneumologie, Inselspital, Universitätsspital Bern</name>
      <address>
        <city>Bern</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 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 13, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 2012</study_first_posted>
  <last_update_submitted>September 18, 2012</last_update_submitted>
  <last_update_submitted_qc>September 18, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 19, 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>Head of Pneumology, Clinical Professor</investigator_title>
  </responsible_party>
  <keyword>Oxygen, Insufflation, COPD, High Flow Treatment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Aspiration</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/NCT01686893
org study id: AN3547
secondary id: AN 3546
nct id: NCT01686893
lead sponsor: 
has dmc: No
Evaluation of Safety and Efficacy of Shorttime TNI Treatment in Patients with COPD Acute
      testing of oxygen demand using TNI vs. standard oxygen application in stable COPD patients An
      investigator-initiated, prospective, controlled, multicenter study
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.
allocation: Non-Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: PaO2
time frame: Measures at Baseline and after 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: Measures at Baseline and after 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: Measures at Baseline and after 60 min
description: Change in the partial carbon dioxide pressure in the arterial blood (blood gas analysis) at a defined oxygen flow rate (L/min)
measure: AaDO2
time frame: Measures at Baseline and after 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: Measures at Baseline and after 60 min
description: Safety of the device in COPD °III or IV patients:
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: Standard Nasal Insufflation of oxygen
arm group type: Active Comparator
description: Standard Nasal Insufflation of oxygen
arm group label: Nasal oxygen insufflation with a TNI 20 oxy device
arm group type: Active Comparator
description: Nasal oxygen insufflation with a TNI 20 oxy device
intervention type: Device
intervention name: Nasal oxygen insufflation with a TNI 20 oxy device
description: Nasal oxygen insufflation with a TNI 20 oxy device
arm group label: Nasal oxygen insufflation with a TNI 20 oxy device
other name: TNI 20 oxy
intervention type: Device
intervention name: Standard Nasal Insufflation of oxygen
description: Standard Nasal Insufflation of oxygen
arm group label: Standard Nasal Insufflation of oxygen
criteria: 
gender: All
minimum age: 30 Years
maximum age: 80 Years
healthy volunteers: No
last name: Christian M Kaehler, MD
role: Principal Investigator
affiliation: Pneumology, 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: Recruiting
contact: 
investigator: 
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: Head of Pneumology, Clinical Professor
mesh term: Respiratory Aspiration