<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/NCT03803384</url>
  </required_header>
  <id_info>
    <org_study_id>COPD FreeO2-Study</org_study_id>
    <nct_id>NCT03803384</nct_id>
  </id_info>
  <brief_title>Effects of an Auto-Regulating Oxygen System Compared to Constant-Flow Oxygen During Walking in Hypoxemic COPD Patients</brief_title>
  <official_title>Effects of an Auto-Regulating Oxygen System Compared to Constant-Flow Oxygen During Walking in Hypoxemic COPD Patients - a Randomized Controlled Trial</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Oxygen therapy is a cornerstone in treating patients with severe chronic obstructive&#xD;
      pulmonary disease. Usually, oxygen supplementation is delivered using constant-flow rates.&#xD;
      Varying oxygenation levels may occur throughout patients´ changing activity. There is some&#xD;
      evidence available that an auto-regulating oxygen flow system (FreeO2), which adjusts the&#xD;
      oxygen flow automatically to prevent desoxygenation could be beneficial in comparison to a&#xD;
      constant oxygen dose of 2 liter/min during walking. However, these possible benefits are&#xD;
      unknown if the FreeO2 is compared to a constant oxygen dose according to the individual&#xD;
      prescription. Therefore, the primary aim of this study is to investigate the effects of&#xD;
      auto-regulated oxygen flow rates compared to constant oxygen flow rates as prescribed&#xD;
      according to international guidelines on walking capacity in patients with COPD.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Rationale:&#xD;
&#xD;
      Hypoxemia is frequently observed in COPD and thus can negatively impact exercise tolerance.&#xD;
      Supplemental oxygen or long-term oxygen therapy is recommended to ensure that the patient is&#xD;
      still able to manage his daily life. Usually, oxygen supplementation is delivered using&#xD;
      constant flow rates during day- and nighttime or as needed. However, studies have shown, that&#xD;
      auto-regulated oxygen flow systems (FreeO2) may enhance the patients endurance, lower the&#xD;
      time in severe hypoxemia and increase the time spent within the SpO2 target range.&#xD;
&#xD;
      Aim of this study is to investigate the effects off an auto-regulated oxygen flow system in&#xD;
      hypoxemic COPD patients on the patient´s endurance, the oxygen saturation, the pCO2 blood&#xD;
      level as well as on heart rate and breathing frequency compared to the effects off the&#xD;
      prescribed constant flow (according to the British Thoracic Society Guidelines for Home&#xD;
      Oxygen Use in Adults) during an endurance shuttle walk test (ESWT). Additionally, patients&#xD;
      experience, e.g. comfort and Preference of the Oxygen-delivery System will be documented.&#xD;
&#xD;
      Design:&#xD;
&#xD;
      This study is a randomized, controlled cross-over trial. Following an initial incremental&#xD;
      shuttle walk test (ISWT) in order to determine the participants individual maximal walking&#xD;
      capacity, the participant will perform 2 endurance shuttle walk tests (ESWT) at 85% of the&#xD;
      maximal walking rate. In randomized order, the participants will perform one ESWT with&#xD;
      constant flow as prescribed and one ESWT with the auto-regulated oxygen flow system.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 7, 2019</start_date>
  <completion_date type="Actual">November 26, 2019</completion_date>
  <primary_completion_date type="Actual">November 26, 2019</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>Double (Participant, Investigator)</masking>
    <masking_description>The Partcipant and Investigator is blinded to the type of oxygen supply (constant flow or auto-regulated flow).</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Endurance time</measure>
    <time_frame>Day 1 and Day 2</time_frame>
    <description>Change of Walking Duration during the ESWT</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change of oxygen saturation during the endurance shuttle walk test.</measure>
    <time_frame>Day 1 and Day 2</time_frame>
    <description>SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to desaturation (SpO2 &lt;=90%) and to severe desaturation (SpO2 &lt;=85%)</measure>
    <time_frame>Day 1 and Day 2</time_frame>
    <description>SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland) and FreeO2 Device.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of capillary partial pressure of CO2 (pCO2) during endurance shuttle walk test</measure>
    <time_frame>Day 1 and Day 2</time_frame>
    <description>pCO2 measured by capillary blood gases taken before and after the ESWT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of capillary partial pressure of O2 (pO2) during endurance shuttle walk test</measure>
    <time_frame>Day 1 and Day 2</time_frame>
    <description>pO2 measured by capillary blood gases taken before and after the ESWT.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of partial pressure of CO2 (pCO2) during endurance shuttle walk test</measure>
    <time_frame>Day 1 and Day 2</time_frame>
    <description>pCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of heart rate during endurance shuttle walk test</measure>
    <time_frame>Day 1 and Day 2</time_frame>
    <description>Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of breathing frequency during endurance shuttle walk test</measure>
    <time_frame>Day 1 and Day 2</time_frame>
    <description>Breathing frequency during the ESWT measured by ApneaLink Air™ (ResMed, ...)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patients Preference due to oxygen delivery system</measure>
    <time_frame>Day 1 and Day 2</time_frame>
    <description>Patients will be asked to rate their experienced comfort after each ESWT</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">55</enrollment>
  <condition>COPD</condition>
  <arm_group>
    <arm_group_label>ESWT Order A and B</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First Endurance Shuttle walk test (A) with supplemental Oxygen therapy via auto-regulated oxygen flow rates (FreeO2) to maintain a oxygen saturation of 92% and second Endurance Shuttle walk (B) test with supplemental Oxygen therapy via constant oxygen flow rates</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ESWT Order B and A</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>First Endurance Shuttle walk test (B) with supplemental Oxygen therapy via constant oxygen flow rates and second Endurance Shuttle walk (A) test with supplemental Oxygen therapy via auto-regulated oxygen flow rates (FreeO2) to maintain a oxygen saturation of 92%</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Oxygen therapy</intervention_name>
    <description>Oxygen supply during ESWT, once with the prescribed constant oxygen flow and once using an auto-regulated oxygen flow system setting the SpO2 target at 92%.</description>
    <arm_group_label>ESWT Order A and B</arm_group_label>
    <arm_group_label>ESWT Order B and A</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  GOLD III/ IV&#xD;
&#xD;
          -  Hypoxemia (PaO2&lt;55 mmHg) under roomair conditions (rest or during exercise) or SpO2&#xD;
             &lt;88% during exercise&#xD;
&#xD;
          -  established Long-term oxygen therapy or given indication for a Long-term oxygen&#xD;
             therapy&#xD;
&#xD;
          -  Age: 40 to 80 years&#xD;
&#xD;
          -  Participation in an inpatient pulmonary rehabilitation program (Schoen Klinik BGL,&#xD;
             Germany)&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Acute Exacerbation of COPD&#xD;
&#xD;
          -  Clinical signs of any acute cardiac comorbidity&#xD;
&#xD;
          -  Not able to walk&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>40 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Klaus Kenn, Prof. Dr.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Philipps University Marburg Medical Center</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Schoen Klinik Berchtesgadener Land</name>
      <address>
        <city>Schönau Am Königssee</city>
        <state>Bayern</state>
        <zip>83471</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Lellouche F, L'Her E, Bouchard PA, Brouillard C, Maltais F. Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Respir Care. 2016 Nov;61(11):1456-1464. doi: 10.4187/respcare.04406. Epub 2016 Oct 18.</citation>
    <PMID>27794080</PMID>
  </reference>
  <verification_date>November 2019</verification_date>
  <study_first_submitted>January 7, 2019</study_first_submitted>
  <study_first_submitted_qc>January 10, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>November 26, 2019</last_update_submitted>
  <last_update_submitted_qc>November 26, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2019</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>Professor Dr. med. Klaus Kenn</investigator_title>
  </responsible_party>
  <keyword>hypoxemia, exercise, oxygen, automatic oxygen-titration</keyword>
  <!-- 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/NCT03803384
org study id: COPD FreeO2-Study
nct id: NCT03803384
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Oxygen therapy is a cornerstone in treating patients with severe chronic obstructive
      pulmonary disease. Usually, oxygen supplementation is delivered using constant-flow rates.
      Varying oxygenation levels may occur throughout patients´ changing activity. There is some
      evidence available that an auto-regulating oxygen flow system (FreeO2), which adjusts the
      oxygen flow automatically to prevent desoxygenation could be beneficial in comparison to a
      constant oxygen dose of 2 liter/min during walking. However, these possible benefits are
      unknown if the FreeO2 is compared to a constant oxygen dose according to the individual
      prescription. Therefore, the primary aim of this study is to investigate the effects of
      auto-regulated oxygen flow rates compared to constant oxygen flow rates as prescribed
      according to international guidelines on walking capacity in patients with COPD.
Rationale:

      Hypoxemia is frequently observed in COPD and thus can negatively impact exercise tolerance.
      Supplemental oxygen or long-term oxygen therapy is recommended to ensure that the patient is
      still able to manage his daily life. Usually, oxygen supplementation is delivered using
      constant flow rates during day- and nighttime or as needed. However, studies have shown, that
      auto-regulated oxygen flow systems (FreeO2) may enhance the patients endurance, lower the
      time in severe hypoxemia and increase the time spent within the SpO2 target range.

      Aim of this study is to investigate the effects off an auto-regulated oxygen flow system in
      hypoxemic COPD patients on the patient´s endurance, the oxygen saturation, the pCO2 blood
      level as well as on heart rate and breathing frequency compared to the effects off the
      prescribed constant flow (according to the British Thoracic Society Guidelines for Home
      Oxygen Use in Adults) during an endurance shuttle walk test (ESWT). Additionally, patients
      experience, e.g. comfort and Preference of the Oxygen-delivery System will be documented.

      Design:

      This study is a randomized, controlled cross-over trial. Following an initial incremental
      shuttle walk test (ISWT) in order to determine the participants individual maximal walking
      capacity, the participant will perform 2 endurance shuttle walk tests (ESWT) at 85% of the
      maximal walking rate. In randomized order, the participants will perform one ESWT with
      constant flow as prescribed and one ESWT with the auto-regulated oxygen flow system.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
masking description: The Partcipant and Investigator is blinded to the type of oxygen supply (constant flow or auto-regulated flow).
measure: Endurance time
time frame: Day 1 and Day 2
description: Change of Walking Duration during the ESWT
measure: Change of oxygen saturation during the endurance shuttle walk test.
time frame: Day 1 and Day 2
description: SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).
measure: Time to desaturation (SpO2 <=90%) and to severe desaturation (SpO2 <=85%)
time frame: Day 1 and Day 2
description: SpO2 measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland) and FreeO2 Device.
measure: Change of capillary partial pressure of CO2 (pCO2) during endurance shuttle walk test
time frame: Day 1 and Day 2
description: pCO2 measured by capillary blood gases taken before and after the ESWT.
measure: Change of capillary partial pressure of O2 (pO2) during endurance shuttle walk test
time frame: Day 1 and Day 2
description: pO2 measured by capillary blood gases taken before and after the ESWT.
measure: Change of partial pressure of CO2 (pCO2) during endurance shuttle walk test
time frame: Day 1 and Day 2
description: pCO2 measured by continuous transcutaneous recording via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland)
measure: Change of heart rate during endurance shuttle walk test
time frame: Day 1 and Day 2
description: Heart rate measured by continuous transcutaneous recordung via Sentec-Digital Monitor® (Sentec, Therwil, Switzerland).
measure: Change of breathing frequency during endurance shuttle walk test
time frame: Day 1 and Day 2
description: Breathing frequency during the ESWT measured by ApneaLink Air™ (ResMed, ...)
measure: Patients Preference due to oxygen delivery system
time frame: Day 1 and Day 2
description: Patients will be asked to rate their experienced comfort after each ESWT
arm group label: ESWT Order A and B
arm group type: Experimental
description: First Endurance Shuttle walk test (A) with supplemental Oxygen therapy via auto-regulated oxygen flow rates (FreeO2) to maintain a oxygen saturation of 92% and second Endurance Shuttle walk (B) test with supplemental Oxygen therapy via constant oxygen flow rates
arm group label: ESWT Order B and A
arm group type: Experimental
description: First Endurance Shuttle walk test (B) with supplemental Oxygen therapy via constant oxygen flow rates and second Endurance Shuttle walk (A) test with supplemental Oxygen therapy via auto-regulated oxygen flow rates (FreeO2) to maintain a oxygen saturation of 92%
intervention type: Other
intervention name: Oxygen therapy
description: Oxygen supply during ESWT, once with the prescribed constant oxygen flow and once using an auto-regulated oxygen flow system setting the SpO2 target at 92%.
arm group label: ESWT Order A and B
arm group label: ESWT Order B and A
criteria: 
gender: All
minimum age: 40 Years
maximum age: 80 Years
healthy volunteers: No
last name: Klaus Kenn, Prof. Dr.
role: Principal Investigator
affiliation: Philipps University Marburg Medical Center
facility: 
country: Germany
citation: Lellouche F, L'Her E, Bouchard PA, Brouillard C, Maltais F. Automatic Oxygen Titration During Walking in Subjects With COPD: A Randomized Crossover Controlled Study. Respir Care. 2016 Nov;61(11):1456-1464. doi: 10.4187/respcare.04406. Epub 2016 Oct 18.
PMID: 27794080
responsible party type: Principal Investigator
investigator affiliation: Schön Klinik Berchtesgadener Land
investigator full name: Klaus Kenn
investigator title: Professor Dr. med. Klaus Kenn