<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/NCT03758508</url>
  </required_header>
  <id_info>
    <org_study_id>03-022018</org_study_id>
    <nct_id>NCT03758508</nct_id>
  </id_info>
  <brief_title>Non-invasive Ventilation Versus High Flow Oxygen</brief_title>
  <acronym>HFO</acronym>
  <official_title>Non-invasive Ventilation Versus High Flow Oxygen Through Nasal Cannula in Pneumonia Associated Acute Hypoxemic Respiratory Failure</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Niguarda Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Niguarda 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 the study is to compare the efficacy of alternating Non Invasive Ventilation&#xD;
      NIV and High Flow Oxygen HFO compared to High Flow Oxygen HFO alone on gas exchanges and&#xD;
      prognosis in pneumonia-associated acute hypoxemic respiratory failure&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Both Non Invasive Ventilation (NIV) and High Flow Oxygen through nasal cannula (HFO) are&#xD;
      widely used in the setting of hypoxemic respiratory failure of heterogeneous etiology, with&#xD;
      no definitive evidence for the superiority of one technique on the other. The purpose of this&#xD;
      study is to determine whether alternating NIV and HFO brings any advantage on gas exchanges&#xD;
      and prognosis compared to the use of HFO alone in the homogeneous setting of&#xD;
      pneumonia-associated acute hypoxemic respiratory failure&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">November 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2025</completion_date>
  <primary_completion_date type="Actual">November 1, 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>Parallel Assignment</intervention_model>
    <intervention_model_description>Efficacy of alternating NIV and HFO compared to HFO alone in the determination of an improvement of PaO2/FiO2 at 21 hours compared to baseline PaO2/FiO2</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>PaO2/FiO2 improvement</measure>
    <time_frame>at baseline and at 21 hours</time_frame>
    <description>Efficacy of alternating NIV and HFO compared to HFO alone in the determination of an improvement of PaO2/FiO2 at 21 hours compared to baseline PaO2/FiO2</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Intensive Care admission</measure>
    <time_frame>30 days</time_frame>
    <description>Rate of admission to Intensive Care Unit in the two arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sensation of device comfort and dyspnoea</measure>
    <time_frame>Baseline, at 21 hours, 45 hours and 30 days after beginning treatment. Optional measures can be taken at 1, 3 and 9 hours</time_frame>
    <description>Evaluation of subjective sensation of device comfort and dyspnoea in the two arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to downgrade to conventional oxygen therapy</measure>
    <time_frame>30 days</time_frame>
    <description>Total amount of hours in which the patient needs to be treated with noninvasive ventilation alternate to versus high flow oxygen through nasal cannula</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital mortality</measure>
    <time_frame>30 days</time_frame>
    <description>Mortality rate in the 2 arms</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>New hospital admission</measure>
    <time_frame>30 days</time_frame>
    <description>Rate of a new hospital admission within 30 days</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PaO2/FiO2 improvement</measure>
    <time_frame>at baseline and at 45 hours</time_frame>
    <description>Efficacy of alternating NIV and HFO compared to HFO alone in the determination of a change in PaO2/FiO2 at 45 hours compared to baseline PaO2/FiO2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PaO2/FiO2 improvement</measure>
    <time_frame>at baseline and at 30 days</time_frame>
    <description>Efficacy of alternating NIV and HFO compared to HFO alone in the determination of a change in PaO2/FiO2 at 30 hours compared to baseline PaO2/FiO2</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">128</enrollment>
  <condition>Pneumonia-associated Acute Hypoxemic Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>HFO</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Continuous high flow oxygen through nasal cannula for 45 hours; longer if the clinical need persists</description>
  </arm_group>
  <arm_group>
    <arm_group_label>NIV/HFO</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Alternating noninvasive ventilation (3 hours) and high flow oxygen through nasal cannula (3 hours) for 45 hours; longer if the clinical need persists</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>High Flow Oxygen nasal cannula</intervention_name>
    <description>High Flow Oxygen nasal cannula</description>
    <arm_group_label>HFO</arm_group_label>
    <arm_group_label>NIV/HFO</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Noninvasive ventilation</intervention_name>
    <description>In this arm, participants receive noninvasive ventilation through an interface (such as full face mask or oro-nasal mask) alternated with continuous high flow oxygen though humidified nasal cannula</description>
    <arm_group_label>NIV/HFO</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of pneumonia based on at least two clinical/laboratory criteria and 1&#xD;
             radiologic criterion among the following:&#xD;
&#xD;
               -  Clinical criteria: fever, cough, purulent sputum, pulmonary examination positive&#xD;
                  for signs consistent with pneumonia&#xD;
&#xD;
               -  Laboratory criteria: leukocytosis (White blood cells &gt;10000/mcL) or leukopenia&#xD;
                  (White blood cells &lt; 4000/mcL), rise of the inflammatory markers&#xD;
&#xD;
               -  Radiologic criteria: consolidations at Chest X-ray or CT scan&#xD;
&#xD;
          -  Hypoxemic respiratory failure, based on all the following criteria&#xD;
&#xD;
               -  PaO2/FiO2 &lt; 300 after at least 15 minutes conventional oxygen therapy with a FiO2&#xD;
                  ≥ 50%&#xD;
&#xD;
               -  Respiratory Rate (RR) ≥ 25/min or need for use of accessory muscles&#xD;
&#xD;
          -  Informed consent to study participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt; 18 years&#xD;
&#xD;
          -  Hypercapnic respiratory failure (pCO2 &gt; 60 mmHg at presentation) such as in Chronic&#xD;
             Obstructive Pulmonary Disease&#xD;
&#xD;
          -  Presence of another cause of hypoxemic respiratory failure - e.g. pulmonary embolism,&#xD;
             acute respiratory distress syndrome (ARDS), pulmonary oedema&#xD;
&#xD;
          -  Hemodynamic instability with necessity for use of inotropes and/or vasopressors&#xD;
&#xD;
          -  Indication for endotracheal intubation (ETI): Glasgow Coma Scale (GCS) &lt;8, agitation,&#xD;
             device intolerance, respiratory arrest&#xD;
&#xD;
          -  Immunosuppression (chronic immunosuppressive therapy, clinical history positive for&#xD;
             any immunodeficiency - congenital or acquired)&#xD;
&#xD;
          -  Do Not Resuscitate (DNR) and Do Not Intubate (DNI) indication&#xD;
&#xD;
          -  Tracheostomy&#xD;
&#xD;
          -  Nocturnal CPAP ventilation therapy&#xD;
&#xD;
          -  Any other condition which the clinician would considered an adjunctive risk for taking&#xD;
             part in the study or that would not permit the participant to complete it&#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>Andrea Bellone, MD</last_name>
    <phone>00396444</phone>
    <phone_ext>2495</phone_ext>
    <email>andrea.bellone@ospedaleniguarda.it</email>
  </overall_contact>
  <location>
    <facility>
      <name>ASST Grande Ospedale Metropolitano Niguarda</name>
      <address>
        <city>Milano</city>
        <zip>20162</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Andrea Bellone, MD</last_name>
      <phone>0039026444</phone>
      <phone_ext>7438</phone_ext>
      <email>andrea.bellone@ospedaleniguarda.it</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>March 2023</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 28, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>March 21, 2023</last_update_submitted>
  <last_update_submitted_qc>March 21, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Noninvasive ventilation</keyword>
  <keyword>High flow oxygen nasal cannula</keyword>
  <keyword>Pneumonia</keyword>
  <keyword>Acute hypoxemic respiratory failure</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pneumonia</mesh_term>
    <mesh_term>Respiratory Insufficiency</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03758508
org study id: 03-022018
nct id: NCT03758508
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to compare the efficacy of alternating Non Invasive Ventilation
      NIV and High Flow Oxygen HFO compared to High Flow Oxygen HFO alone on gas exchanges and
      prognosis in pneumonia-associated acute hypoxemic respiratory failure
Both Non Invasive Ventilation (NIV) and High Flow Oxygen through nasal cannula (HFO) are
      widely used in the setting of hypoxemic respiratory failure of heterogeneous etiology, with
      no definitive evidence for the superiority of one technique on the other. The purpose of this
      study is to determine whether alternating NIV and HFO brings any advantage on gas exchanges
      and prognosis compared to the use of HFO alone in the homogeneous setting of
      pneumonia-associated acute hypoxemic respiratory failure
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Efficacy of alternating NIV and HFO compared to HFO alone in the determination of an improvement of PaO2/FiO2 at 21 hours compared to baseline PaO2/FiO2
primary purpose: Treatment
masking: None (Open Label)
measure: PaO2/FiO2 improvement
time frame: at baseline and at 21 hours
description: Efficacy of alternating NIV and HFO compared to HFO alone in the determination of an improvement of PaO2/FiO2 at 21 hours compared to baseline PaO2/FiO2
measure: Intensive Care admission
time frame: 30 days
description: Rate of admission to Intensive Care Unit in the two arms
measure: Sensation of device comfort and dyspnoea
time frame: Baseline, at 21 hours, 45 hours and 30 days after beginning treatment. Optional measures can be taken at 1, 3 and 9 hours
description: Evaluation of subjective sensation of device comfort and dyspnoea in the two arms
measure: Time to downgrade to conventional oxygen therapy
time frame: 30 days
description: Total amount of hours in which the patient needs to be treated with noninvasive ventilation alternate to versus high flow oxygen through nasal cannula
measure: In-hospital mortality
time frame: 30 days
description: Mortality rate in the 2 arms
measure: New hospital admission
time frame: 30 days
description: Rate of a new hospital admission within 30 days
measure: PaO2/FiO2 improvement
time frame: at baseline and at 45 hours
description: Efficacy of alternating NIV and HFO compared to HFO alone in the determination of a change in PaO2/FiO2 at 45 hours compared to baseline PaO2/FiO2
measure: PaO2/FiO2 improvement
time frame: at baseline and at 30 days
description: Efficacy of alternating NIV and HFO compared to HFO alone in the determination of a change in PaO2/FiO2 at 30 hours compared to baseline PaO2/FiO2
arm group label: HFO
arm group type: Active Comparator
description: Continuous high flow oxygen through nasal cannula for 45 hours; longer if the clinical need persists
arm group label: NIV/HFO
arm group type: Active Comparator
description: Alternating noninvasive ventilation (3 hours) and high flow oxygen through nasal cannula (3 hours) for 45 hours; longer if the clinical need persists
intervention type: Device
intervention name: High Flow Oxygen nasal cannula
description: High Flow Oxygen nasal cannula
arm group label: HFO
arm group label: NIV/HFO
intervention type: Device
intervention name: Noninvasive ventilation
description: In this arm, participants receive noninvasive ventilation through an interface (such as full face mask or oro-nasal mask) alternated with continuous high flow oxygen though humidified nasal cannula
arm group label: NIV/HFO
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrea Bellone, MD
phone: 00396444
phone ext: 2495
email: andrea.bellone@ospedaleniguarda.it
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Sponsor
mesh term: Pneumonia
mesh term: Respiratory Insufficiency
sharing ipd: Undecided