<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/NCT04471220</url>
  </required_header>
  <id_info>
    <org_study_id>2019-23</org_study_id>
    <nct_id>NCT04471220</nct_id>
  </id_info>
  <brief_title>Exercise Capacity Under Various FiO2 and Oxygen Flow Rates Using HFNC</brief_title>
  <official_title>Examination of Exercise Capacity Under Various Oxygen Concentrations and Oxygen Flow Rates Using High Flow Nasal Cannula</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Hospital Organization Minami Kyoto Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Hospital Organization Minami Kyoto Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to compare the exercise capacity (6-min walking distance) under&#xD;
      the following 4 conditions using High-flow nasal cannula (HFNC); 1. FIO2 value that the&#xD;
      minimum SpO2 value in a 6-minute walking test (6MWT) is 86-88%, and a flow of 10 L/min 2.&#xD;
      FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 40-50 L/min 3. FIO2&#xD;
      value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 10 L/min 4. FIO2 value&#xD;
      that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 40-50 L/min&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the pervious study, the investigators demonstrated that 4 weeks of training using both&#xD;
      high FIO2 and high flow through an HFNC significantly improved the 6MWD compared with&#xD;
      training using a 6 L/min nasal cannula. However, it was unclear whether the effects of&#xD;
      pulmonary rehabilitation under HFNC were due to high FIO2, high flow rate, or a synergistic&#xD;
      effect. It is also unknown whether there are differences in the effects of pulmonary&#xD;
      rehabilitation under HFNC for each underlying disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 1, 2020</start_date>
  <completion_date type="Actual">September 29, 2022</completion_date>
  <primary_completion_date type="Actual">September 29, 2022</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>Other</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Difference in 6MWD between two conditions (&quot;Low FIO2 and high flow rate&quot; and &quot;High FIO2 and high flow rate&quot;)</measure>
    <time_frame>through study completion, an average of 2 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Difference in 6MWD between four conditions</measure>
    <time_frame>through study completion, an average of 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in SpO2 value during 6MWT between four conditions</measure>
    <time_frame>through study completion, an average of 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in Pulse rate value during 6MWT between four conditions</measure>
    <time_frame>through study completion, an average of 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in Dyspnea during 6MWT between four conditions</measure>
    <time_frame>through study completion, an average of 2 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Difference in lower limb fatigue during 6MWT between four conditions</measure>
    <time_frame>through study completion, an average of 2 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>High-flow Nasal Cannula</condition>
  <condition>Exercise Capacity</condition>
  <condition>Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Low FIO2 and low flow rate under HFNC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 10 L/min).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low FIO2 and high flow rate under HFNC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 40-50 L/min).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High FIO2 and low flow rate under HFNC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 10 L/min).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>High FIO2 and high flow rate under HFNC</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 40-50 L/min).</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High-flow nasal cannula</intervention_name>
    <description>The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.</description>
    <arm_group_label>High FIO2 and high flow rate under HFNC</arm_group_label>
    <arm_group_label>High FIO2 and low flow rate under HFNC</arm_group_label>
    <arm_group_label>Low FIO2 and high flow rate under HFNC</arm_group_label>
    <arm_group_label>Low FIO2 and low flow rate under HFNC</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subjects with a minimum SPO2 of 88% or less during performing 6MWT under HFNC (FIO2&#xD;
             0.21 and a flow rate of 10L/min)&#xD;
&#xD;
          -  Subjects who have been clinically stable for the last 2 weeks&#xD;
&#xD;
          -  Subjects with written informed consent to participate in this study&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subjects with severe cardiovascular disease, liver disease, neurological disease, and&#xD;
             renal failure&#xD;
&#xD;
          -  Subjects who needed antimicrobial agent or steroid administration for pneumonia and&#xD;
             exacerbation of respiratory disease in the last 2 weeks&#xD;
&#xD;
          -  Subjects who cannot undergo 6MWT due to severe heart failure, arteriosclerosis&#xD;
             obliterans or spinal disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>National Hospital Organization Minami Kyoto Hospital</name>
      <address>
        <city>Joyo</city>
        <state>Kyoto</state>
        <zip>610-0113</zip>
        <country>Japan</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2022</verification_date>
  <study_first_submitted>July 7, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>September 29, 2022</last_update_submitted>
  <last_update_submitted_qc>September 29, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>HFNC</keyword>
  <keyword>6MWD</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</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/NCT04471220
org study id: 2019-23
nct id: NCT04471220
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of this study is to compare the exercise capacity (6-min walking distance) under
      the following 4 conditions using High-flow nasal cannula (HFNC); 1. FIO2 value that the
      minimum SpO2 value in a 6-minute walking test (6MWT) is 86-88%, and a flow of 10 L/min 2.
      FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 40-50 L/min 3. FIO2
      value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 10 L/min 4. FIO2 value
      that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 40-50 L/min
In the pervious study, the investigators demonstrated that 4 weeks of training using both
      high FIO2 and high flow through an HFNC significantly improved the 6MWD compared with
      training using a 6 L/min nasal cannula. However, it was unclear whether the effects of
      pulmonary rehabilitation under HFNC were due to high FIO2, high flow rate, or a synergistic
      effect. It is also unknown whether there are differences in the effects of pulmonary
      rehabilitation under HFNC for each underlying disease.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Other
masking: Single (Participant)
measure: Difference in 6MWD between two conditions ("Low FIO2 and high flow rate" and "High FIO2 and high flow rate")
time frame: through study completion, an average of 2 weeks
measure: Difference in 6MWD between four conditions
time frame: through study completion, an average of 2 weeks
measure: Difference in SpO2 value during 6MWT between four conditions
time frame: through study completion, an average of 2 weeks
measure: Difference in Pulse rate value during 6MWT between four conditions
time frame: through study completion, an average of 2 weeks
measure: Difference in Dyspnea during 6MWT between four conditions
time frame: through study completion, an average of 2 weeks
measure: Difference in lower limb fatigue during 6MWT between four conditions
time frame: through study completion, an average of 2 weeks
arm group label: Low FIO2 and low flow rate under HFNC
arm group type: Active Comparator
description: In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 10 L/min).
arm group label: Low FIO2 and high flow rate under HFNC
arm group type: Active Comparator
description: In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 86-88%, and a flow of 40-50 L/min).
arm group label: High FIO2 and low flow rate under HFNC
arm group type: Active Comparator
description: In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 10 L/min).
arm group label: High FIO2 and high flow rate under HFNC
arm group type: Active Comparator
description: In this condition, patients have undergone 6MWT under the HFNC (FIO2 value that the minimum SpO2 value in a 6MWT is 92-94%, and a flow of 40-50 L/min).
intervention type: Device
intervention name: High-flow nasal cannula
description: The nasal high flow therapy has enabled high flow oxygen to be derived through nasal cannula. This mode not only allows constant FiO2 during peak inspiratory flow but also confers benefits including a low level of continuous positive airway pressure with increased end-expiratory lung volume and reduced work of breathing, partly through intrinsic positive end-expiration pressure compensation and dead space washout. The inspired gases are warmed and humidified, improving comfort and possibly reducing airway inflammation, leading to improved drainage of respiratory secretions.
arm group label: High FIO2 and high flow rate under HFNC
arm group label: High FIO2 and low flow rate under HFNC
arm group label: Low FIO2 and high flow rate under HFNC
arm group label: Low FIO2 and low flow rate under HFNC
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
country: Japan
responsible party type: Sponsor
mesh term: Respiratory Insufficiency