<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/NCT04468126</url>
  </required_header>
  <id_info>
    <org_study_id>SOHO</org_study_id>
    <nct_id>NCT04468126</nct_id>
  </id_info>
  <brief_title>Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure</brief_title>
  <acronym>SOHO</acronym>
  <official_title>Impact on Mortality of an Oxygenation Strategy Including Standard Oxygen Versus High Flow Nasal Cannula Oxygen Therapy in Patients With Acute Hypoxemic Respiratory Failure: a Prospective, Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Poitiers University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Poitiers University 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>
      First-line therapy of patients with acute respiratory failure consists in oxygen delivery&#xD;
      through standard oxygen, high-flow nasal oxygen therapy through cannula or non-invasive&#xD;
      ventilation. Non-invasive ventilation in acute hypoxemic respiratory failure is not&#xD;
      recommended. In a large randomized controlled study, high-flow nasal oxygen has been&#xD;
      described as superior to non-invasive ventilation and standard oxygen in terms of mortality&#xD;
      but not of intubation. Paradoxically in immunocompromised patients, high-flow nasal oxygen&#xD;
      has not been shown to be superior to standard oxygen. To improve the level of evidence of&#xD;
      daily clinical practice, we propose comparing high-flow nasal oxygen versus standard oxygen,&#xD;
      in terms of mortality in all patients with acute hypoxemic respiratory failure&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 11, 2020</start_date>
  <completion_date type="Anticipated">February 1, 2024</completion_date>
  <primary_completion_date type="Anticipated">January 11, 2023</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Mortality at 28 days after randomization</measure>
    <time_frame>Day 28</time_frame>
    <description>Death between randomization and 28 days after randomization</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Failure of the oxygenation strategy between randomization and D28</measure>
    <time_frame>Day 28</time_frame>
    <description>Intubation between randomization and D28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mortality in ICU, in hospital, and day 90</measure>
    <time_frame>Day 90</time_frame>
    <description>Death between randomization and end of stay in ICU, hospital. Death between randomization and day 90.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of ventilation free days at Day 28</measure>
    <time_frame>Day 28</time_frame>
    <description>days alive and without intubation between day 1 and day 28</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration of ICU and hospital stay</measure>
    <time_frame>Day 90</time_frame>
    <description>ICU and hospital stay between randomisation and end of stay in ICU and hospital</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Complications during the ICU stay</measure>
    <time_frame>Day 90</time_frame>
    <description>Complications during the ICU stay include: septic shock, nosocomial pneumonia, cardiac arrhythmia, and cardiac arrest.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dyspnea</measure>
    <time_frame>Hour 6</time_frame>
    <description>feeling is evaluated using a 5-point Likert scale, indicating marked improvement (+2), slight improvement (+1), no change (0), slight deterioration (-1) and marked deterioration (-2)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comfort</measure>
    <time_frame>Hour 6</time_frame>
    <description>comfort is evaluated using a 100-mm visual-analogue scale, from 0, i.e. &quot;no discomfort&quot;, to100, i.e. &quot;maximal imaginable discomfort&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Level of oxygenation</measure>
    <time_frame>Hour 48</time_frame>
    <description>Oxygenation is assessed by arterial blood gas sample</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Organ Failure during the 48 hours after intubation.</measure>
    <time_frame>Day 28</time_frame>
    <description>Organ failure is evaluated by the Sepsis-related Organ Failure Assessment (SOFA) score during the 48 hours after intubation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration between the time when prespecified criteria of intubation are met and intubation</measure>
    <time_frame>Day 28</time_frame>
    <description>interval between the time when prespecified criteria of intubation are met and intubation</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Duration between treatment initiation and intubation</measure>
    <time_frame>Day 28</time_frame>
    <description>Interval between treatment initiation and intubation</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">1110</enrollment>
  <condition>Acute Respiratory Failure</condition>
  <condition>Hypoxemic Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>standard oxygen group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In order to maintain SpO2 between 92 and 96%</description>
  </arm_group>
  <arm_group>
    <arm_group_label>high-flow nasal cannula oxygen group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>At least 50 L/min adjusted in order to maintain SpO2 between 92 and 96 %</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Standard oxygen</intervention_name>
    <description>Standard low flow oxygen therapy through facemask or non-rebreathing mask at least 10 L/min.</description>
    <arm_group_label>standard oxygen group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>High-flow nasal oxygen therapy</intervention_name>
    <description>Humidified and heated oxygen with a gas flow at least 50 l/min through nasal cannula and inspired fraction of oxygen adjusted in order to maintain a SpO2 between 92 and 96%</description>
    <arm_group_label>high-flow nasal cannula oxygen group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        All consecutive patients older than 18 years with an acute hypoxemic respiratory failure&#xD;
        will be enrolled if they meet all the following criteria:&#xD;
&#xD;
          -  Respiratory rate &gt;25 breaths/min whatever the oxygen support&#xD;
&#xD;
          -  Pulmonary infiltrate,&#xD;
&#xD;
          -  PaO2/FiO2 ≤200 mmHg&#xD;
&#xD;
          -  Informed consent from the patient or relatives.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  PaCO2 &gt; 45 mm Hg&#xD;
&#xD;
          -  Need for emergent intubation: pulse oximetry &lt; 90% with maximum oxygen support,&#xD;
             respiratory arrest, cardiac arrest, or Glasgow coma scale below 8 points&#xD;
&#xD;
          -  Hemodynamic instability defined by signs of hypoperfusion or use of vasopressors &gt; 0.3&#xD;
             µg/kg/min&#xD;
&#xD;
          -  Glasgow coma scale equal to or below 12 points&#xD;
&#xD;
          -  Exacerbation of chronic lung disease including chronic obstructive pulmonary disease&#xD;
             (grade 3 or 4 of Gold classification), or another chronic lung disease with long term&#xD;
             oxygen or ventilatory support&#xD;
&#xD;
          -  Cardiogenic pulmonary edema as main reason for acute respiratory failure&#xD;
&#xD;
          -  Coronavirus SARS-2 infection as reason for acute respiratory failure (the SOHO-COVID&#xD;
             study has been completed)&#xD;
&#xD;
          -  Post-extubation respiratory failure within 7 days after extubation,&#xD;
&#xD;
          -  Post-operative patients within 7 days after abdominal or cardiothoracic surgery,&#xD;
&#xD;
          -  Do not intubate order;&#xD;
&#xD;
          -  Already included in the study, refusal to participate or participation in another&#xD;
             interventional study with the same primary outcome.&#xD;
&#xD;
          -  Patients without any healthcare insurance scheme or not benefiting from it through a&#xD;
             third party,&#xD;
&#xD;
          -  Persons under law protection, namely minors, pregnant or breastfeeding women, persons&#xD;
             deprived of their liberty by a judicial or administrative decision.&#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_official>
    <last_name>Jean-Pierre FRAT, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Poitiers</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Jean-Pierre FRAT, PhD</last_name>
    <phone>05 49 44 60 64</phone>
    <phone_ext>+33</phone_ext>
    <email>jean-pierre.frat@chu-poitiers.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Céline DELETAGE, PhD</last_name>
    <phone>05 49 44 38 54</phone>
    <phone_ext>+33</phone_ext>
    <email>celine.deletage@chu-poitiers.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CHu Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jean-pierre FRAT, Dr</last_name>
      <phone>+33-5-49-44-40-07</phone>
      <email>jean-pierre.frat@chu-poitiers.fr</email>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 13, 2020</study_first_posted>
  <last_update_submitted>November 16, 2022</last_update_submitted>
  <last_update_submitted_qc>November 16, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>acute hypoxemic respiratory failure</keyword>
  <keyword>de novo respiratory failure</keyword>
  <keyword>high-flow nasal oxygen</keyword>
  <keyword>standard oxygen</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/NCT04468126
org study id: SOHO
nct id: NCT04468126
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
First-line therapy of patients with acute respiratory failure consists in oxygen delivery
      through standard oxygen, high-flow nasal oxygen therapy through cannula or non-invasive
      ventilation. Non-invasive ventilation in acute hypoxemic respiratory failure is not
      recommended. In a large randomized controlled study, high-flow nasal oxygen has been
      described as superior to non-invasive ventilation and standard oxygen in terms of mortality
      but not of intubation. Paradoxically in immunocompromised patients, high-flow nasal oxygen
      has not been shown to be superior to standard oxygen. To improve the level of evidence of
      daily clinical practice, we propose comparing high-flow nasal oxygen versus standard oxygen,
      in terms of mortality in all patients with acute hypoxemic respiratory failure
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Mortality at 28 days after randomization
time frame: Day 28
description: Death between randomization and 28 days after randomization
measure: Failure of the oxygenation strategy between randomization and D28
time frame: Day 28
description: Intubation between randomization and D28
measure: Mortality in ICU, in hospital, and day 90
time frame: Day 90
description: Death between randomization and end of stay in ICU, hospital. Death between randomization and day 90.
measure: Number of ventilation free days at Day 28
time frame: Day 28
description: days alive and without intubation between day 1 and day 28
measure: Duration of ICU and hospital stay
time frame: Day 90
description: ICU and hospital stay between randomisation and end of stay in ICU and hospital
measure: Complications during the ICU stay
time frame: Day 90
description: Complications during the ICU stay include: septic shock, nosocomial pneumonia, cardiac arrhythmia, and cardiac arrest.
measure: Dyspnea
time frame: Hour 6
description: feeling is evaluated using a 5-point Likert scale, indicating marked improvement (+2), slight improvement (+1), no change (0), slight deterioration (-1) and marked deterioration (-2)
measure: Comfort
time frame: Hour 6
description: comfort is evaluated using a 100-mm visual-analogue scale, from 0, i.e. "no discomfort", to100, i.e. "maximal imaginable discomfort"
measure: Level of oxygenation
time frame: Hour 48
description: Oxygenation is assessed by arterial blood gas sample
measure: Organ Failure during the 48 hours after intubation.
time frame: Day 28
description: Organ failure is evaluated by the Sepsis-related Organ Failure Assessment (SOFA) score during the 48 hours after intubation.
measure: Duration between the time when prespecified criteria of intubation are met and intubation
time frame: Day 28
description: interval between the time when prespecified criteria of intubation are met and intubation
measure: Duration between treatment initiation and intubation
time frame: Day 28
description: Interval between treatment initiation and intubation
arm group label: standard oxygen group
arm group type: Active Comparator
description: In order to maintain SpO2 between 92 and 96%
arm group label: high-flow nasal cannula oxygen group
arm group type: Experimental
description: At least 50 L/min adjusted in order to maintain SpO2 between 92 and 96 %
intervention type: Other
intervention name: Standard oxygen
description: Standard low flow oxygen therapy through facemask or non-rebreathing mask at least 10 L/min.
arm group label: standard oxygen group
intervention type: Other
intervention name: High-flow nasal oxygen therapy
description: Humidified and heated oxygen with a gas flow at least 50 l/min through nasal cannula and inspired fraction of oxygen adjusted in order to maintain a SpO2 between 92 and 96%
arm group label: high-flow nasal cannula oxygen group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Jean-Pierre FRAT, PhD
role: Principal Investigator
affiliation: CHU Poitiers
last name: Jean-Pierre FRAT, PhD
phone: 05 49 44 60 64
phone ext: +33
email: jean-pierre.frat@chu-poitiers.fr
last name: Céline DELETAGE, PhD
phone: 05 49 44 38 54
phone ext: +33
email: celine.deletage@chu-poitiers.fr
facility: 
status: Recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: Respiratory Insufficiency