<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/NCT03835741</url>
  </required_header>
  <id_info>
    <org_study_id>21641</org_study_id>
    <nct_id>NCT03835741</nct_id>
  </id_info>
  <brief_title>Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop</brief_title>
  <acronym>FreeO2 HypHop</acronym>
  <official_title>Reduction of Length of Stay by Automated Adjustment of Oxygen on Patient With Acute COPD Exacerbation - FreeO2 HypHop</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Laval University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Laval University</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 aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device)&#xD;
      can reduce the hospital length of stay for acute exacerbation of COPD with comparison of&#xD;
      manual oxygen titration.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device)&#xD;
      can reduce the hospital length of stay for acute exacerbation of COPD with comparison of&#xD;
      manual oxygen titration.&#xD;
&#xD;
      Patients with severe acute exacerbation of COPD requiring hospitalization will be included in&#xD;
      this randomized controlled study and will be managed with either manual oxygen titration or&#xD;
      automated oxygen titration (FreeO2 arm).&#xD;
&#xD;
      The impact on the hospital length of stay will be evaluated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Anticipated">June 2025</completion_date>
  <primary_completion_date type="Anticipated">December 2024</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital length of stay</measure>
    <time_frame>From hospital admission until hospital discharge (around one week expected)</time_frame>
    <description>Duration of the hospital length of stay</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ICU transfer</measure>
    <time_frame>During hospital stay : from hospital admission until hospital discharge (around one week expected)</time_frame>
    <description>The rate of ICU admission during hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Oxygen administration duration</measure>
    <time_frame>During hospital stay : from hospital admission until hospital discharge (around one week expected)</time_frame>
    <description>The number of days patient receive oxygen supplementation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Non invasive or invasive mechanic ventilation rate use</measure>
    <time_frame>During hospital stay: from hospital admission until hospital discharge (around one week expected)</time_frame>
    <description>The rate of NIV use during length of stay in hospital</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Arterial or Capillary blood gaz evolution</measure>
    <time_frame>During hospital stay - From hospital admission until hospital discharge (around one week expected)</time_frame>
    <description>Evaluation of the rate of respiratory acidosis (pH&lt;7.35 and PaCO2&gt;45mmHg)</description>
  </other_outcome>
  <other_outcome>
    <measure>Hospital Readmission rate after hospital discharge</measure>
    <time_frame>Until day 90 after study inclusion</time_frame>
    <description>Rate of hospital readmission after initial hospital discharge</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">102</enrollment>
  <condition>Oxygen Toxicity</condition>
  <condition>COPD Exacerbation</condition>
  <condition>Hyperoxia</condition>
  <condition>Hypoxemia</condition>
  <condition>Hypoxic Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>Automated Oxygen titration</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this arm, an automated adjustment of oxygen during patient hospitalisation by FreeO2 device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Manual Oxygen titration</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>In this arm, a manual adjustment of oxygen during patient hospitalisation by hospital staff</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FreeO2</intervention_name>
    <description>an automated adjustment of oxygen during patient hospitalisation by FreeO2 device</description>
    <arm_group_label>Automated Oxygen titration</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>manual titration</intervention_name>
    <description>a manual adjustment of oxygen during patient hospitalisation by hospital staff</description>
    <arm_group_label>Manual Oxygen titration</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  COPD or suspected COPD ( Age&gt;40, active or smoking history &gt; 10pack/years), -&#xD;
&#xD;
          -  Acute exacerbation (increasing dyspnea recently)&#xD;
&#xD;
          -  One or more of the following criteria: increased sputum, modification of sputum&#xD;
             purulence,increased dyspnea,&#xD;
&#xD;
          -  Moderate oxygen therapy: Oxygen flow &lt; 8 lpm (or FiO2 &lt; 0.60) to maintain a SpO2 &gt;or =&#xD;
             92% (for long term oxygen therapy, the oxygen flow must be greater than baseline flow&#xD;
             to maintain SpO2 &gt; or = 92%)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  COPD exacerbation with diagnosis highly related to pulmonary embolism, cardiac&#xD;
             pulmonary edema, pneumothorax or sedative overdose&#xD;
&#xD;
          -  No SpO2 signal&#xD;
&#xD;
          -  Encephalopathy score &gt; 2&#xD;
&#xD;
          -  Delirium&#xD;
&#xD;
          -  Other respiratory support needed (intubation or NIV)&#xD;
&#xD;
          -  Patient on withdrawal life support&#xD;
&#xD;
          -  Advance neoplasia (palliative stage) or terminal respiratory distress&#xD;
&#xD;
          -  Unavailability of FreeO2 device at the randomisation&#xD;
&#xD;
          -  Non optimal patient collaboration&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>François Lellouche</last_name>
    <phone>4186568711</phone>
    <phone_ext>3572</phone_ext>
    <email>francois.lellouche@criucpq.ulaval.ca</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Pierre-Alexandre Bouchard</last_name>
    <phone>4186568711</phone>
    <phone_ext>2712</phone_ext>
    <email>pierre-alexandre.bouchard@criucpq.ulaval.ca</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Institut Universitaire de Cardiologie et de Pneumologie de Québec</name>
      <address>
        <city>Quebec</city>
        <zip>G1V4G5</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Francois Lellouche</last_name>
      <email>francois.lellouche@criucpq.ulaval.ca</email>
    </contact>
  </location>
  <location_countries>
    <country>Canada</country>
  </location_countries>
  <verification_date>April 2023</verification_date>
  <study_first_submitted>January 14, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 11, 2019</study_first_posted>
  <last_update_submitted>April 3, 2023</last_update_submitted>
  <last_update_submitted_qc>April 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">April 4, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Laval University</investigator_affiliation>
    <investigator_full_name>François Lellouche</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Pulmonary Disease, Chronic Obstructive</mesh_term>
    <mesh_term>Hypoxia</mesh_term>
    <mesh_term>Hyperoxia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03835741
org study id: 21641
nct id: NCT03835741
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device)
      can reduce the hospital length of stay for acute exacerbation of COPD with comparison of
      manual oxygen titration.
The aim of this study is to evaluate if automated adjustment of oxygen (with FreeO2 device)
      can reduce the hospital length of stay for acute exacerbation of COPD with comparison of
      manual oxygen titration.

      Patients with severe acute exacerbation of COPD requiring hospitalization will be included in
      this randomized controlled study and will be managed with either manual oxygen titration or
      automated oxygen titration (FreeO2 arm).

      The impact on the hospital length of stay will be evaluated.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Hospital length of stay
time frame: From hospital admission until hospital discharge (around one week expected)
description: Duration of the hospital length of stay
measure: ICU transfer
time frame: During hospital stay : from hospital admission until hospital discharge (around one week expected)
description: The rate of ICU admission during hospital stay
measure: Oxygen administration duration
time frame: During hospital stay : from hospital admission until hospital discharge (around one week expected)
description: The number of days patient receive oxygen supplementation
measure: Non invasive or invasive mechanic ventilation rate use
time frame: During hospital stay: from hospital admission until hospital discharge (around one week expected)
description: The rate of NIV use during length of stay in hospital
measure: Arterial or Capillary blood gaz evolution
time frame: During hospital stay - From hospital admission until hospital discharge (around one week expected)
description: Evaluation of the rate of respiratory acidosis (pH<7.35 and PaCO2>45mmHg)
measure: Hospital Readmission rate after hospital discharge
time frame: Until day 90 after study inclusion
description: Rate of hospital readmission after initial hospital discharge
arm group label: Automated Oxygen titration
arm group type: Experimental
description: In this arm, an automated adjustment of oxygen during patient hospitalisation by FreeO2 device
arm group label: Manual Oxygen titration
arm group type: Other
description: In this arm, a manual adjustment of oxygen during patient hospitalisation by hospital staff
intervention type: Device
intervention name: FreeO2
description: an automated adjustment of oxygen during patient hospitalisation by FreeO2 device
arm group label: Automated Oxygen titration
intervention type: Other
intervention name: manual titration
description: a manual adjustment of oxygen during patient hospitalisation by hospital staff
arm group label: Manual Oxygen titration
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: François Lellouche
phone: 4186568711
phone ext: 3572
email: francois.lellouche@criucpq.ulaval.ca
last name: Pierre-Alexandre Bouchard
phone: 4186568711
phone ext: 2712
email: pierre-alexandre.bouchard@criucpq.ulaval.ca
facility: 
status: Recruiting
contact: 
country: Canada
responsible party type: Principal Investigator
investigator affiliation: Laval University
investigator full name: François Lellouche
investigator title: Principal Investigator
mesh term: Respiratory Insufficiency
mesh term: Pulmonary Disease, Chronic Obstructive
mesh term: Hypoxia
mesh term: Hyperoxia
sharing ipd: No