<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/NCT02978300</url>
  </required_header>
  <id_info>
    <org_study_id>2016-A00834-47</org_study_id>
    <nct_id>NCT02978300</nct_id>
  </id_info>
  <brief_title>HFNC Alone or Associated With NIV for Immunocompromised Patients Admitted to ICU for Acute Respiratory Failure</brief_title>
  <acronym>FLORALI-IM</acronym>
  <official_title>High-Flow Nasal Cannula Oxygen Therapy (HFNC) Alone or Associated With Noninvasive Ventilation (NIV) for Immunocompromised Patients Admitted to Intensive Care Unit for Acute Respiratory Failure : FLORALI-Immunodéprimés</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>Yes</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>
      Acute respiratory failure is the leading cause of ICU admission of immunocompromized&#xD;
      patients. In this subgroup of patients, the need for intubation and invasive mechanical&#xD;
      ventilation occurs in about 50% of cases and is associated with very a high mortality rate,&#xD;
      reaching 70% of cases. Therefore, noninvasive oxygenation strategies have been developed to&#xD;
      avoid intubation.&#xD;
&#xD;
      More than 15 years ago, 2 trials have suggested that NIV could decrease intubation and&#xD;
      mortality rates of immunocompromized patients as compared to standard oxygen through a mask.&#xD;
      However these results have not been confirmed in a recent large trial.&#xD;
&#xD;
      HFNC is a recent and well-tolerated oxygenation technique. In a recent trial, HFNC alone&#xD;
      could decrease mortality and intubation rates in patients with ARF as compared to NIV.&#xD;
      Similar findings have been reported in a post-hoc analysis on immunocompromized patients&#xD;
      excluding those with profound neutropenia. Likewise in a retrospective monocentric cohort of&#xD;
      immunocompromized patients, we reported better outcomes with HFNC than with NIV.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 21, 2017</start_date>
  <completion_date type="Actual">August 30, 2019</completion_date>
  <primary_completion_date type="Actual">April 2, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>mortality rates</measure>
    <time_frame>day 28</time_frame>
    <description>Mortality rates at day 28 after randomization will be compared between the 2 groups</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Acute Respiratory Failure</condition>
  <condition>Immunosuppression</condition>
  <arm_group>
    <arm_group_label>NIV/HFNC group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Continuous NIV for at least 4 hours until clinical improvement then intermittent 1-hour sessions for a minimal duration of 12 hours a day. Between NIV sessions HFNC will be delivered as in the HFNC group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>HFNC group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Continuous HFNC alone 24h/24 until weaning or intubation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NIV/HFNC</intervention_name>
    <description>Pressure support level to achieve an expired tidal volume between 6 and 8 ml/kg of predicted body weight Positive end expiratory pressure from 5 to 10 cm H2O, aiming a PEEP level ≥ 8 cm H2O FiO2 set to achieve SpO2 ≥ 92%</description>
    <arm_group_label>NIV/HFNC group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>HFNC</intervention_name>
    <description>Gas flow of 60 l/min and FiO2 set to achieve SpO2 ≥ 92%</description>
    <arm_group_label>HFNC group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥ 18&#xD;
&#xD;
          -  Admission to ICU for acute respiratory failure defined by all of the following&#xD;
             criteria:&#xD;
&#xD;
               -  Dyspnea at rest with RR ≥ 25 breaths/min&#xD;
&#xD;
               -  PaCO2 ≤ 50 mm Hg&#xD;
&#xD;
               -  PaO2/FiO2 ≤ 300 mm Hg under oxygen ≥ 10 l/min through a mask or HFNC or NIV (for&#xD;
                  patients under oxygen FiO2 will be calculated using the following formula: oxygen&#xD;
                  flow in liters per minute x 3 + 21)&#xD;
&#xD;
          -  Immunosuppresion defined by 1 of the following criteria:&#xD;
&#xD;
               -  Hematological malignancy (active or remitting &lt; 5 years)&#xD;
&#xD;
               -  Allogenic stem cell transplantation &lt; 5 years&#xD;
&#xD;
               -  Solid cancer (active)&#xD;
&#xD;
               -  Leucopenia &lt; 1 G/l or neutropenia ≤ 0.5 G/l after chemotherapy&#xD;
&#xD;
               -  Solid organ transplantation&#xD;
&#xD;
               -  AIDS (not only HIV)&#xD;
&#xD;
               -  Treatment with immunosuppressive or immunomodulatory drugs&#xD;
&#xD;
               -  Systemic steroids ≥ 0.5 mg/kg/d of prednisone-equivalent for ≥ 3 weeks&#xD;
&#xD;
          -  Non opposition to participate obtained from the patient or their legally acceptable&#xD;
             representative.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindication of NIV (patient refusal, cardiac arrest, coma, not drained&#xD;
             pneumothorax, unresolving vomiting, upper airways obstruction, hematemesis, severe&#xD;
             facial trauma)&#xD;
&#xD;
          -  Chronic respiratory failure with altered pulmonary function tests&#xD;
&#xD;
          -  Overt cardiogenic pulmonary edema&#xD;
&#xD;
          -  Urgent need for intubation&#xD;
&#xD;
          -  Severe shock (vasopressors &gt; 0.3 µg/kg/min to maintain SAP &gt; 90 mm Hg)&#xD;
&#xD;
          -  Impaired consciousness (Glasgow coma scale score ≤ 12) or agitation&#xD;
&#xD;
          -  Surgery under general anesthesia &lt; 7 days&#xD;
&#xD;
          -  Previously included in the trial&#xD;
&#xD;
          -  Do-not-intubate order&#xD;
&#xD;
          -  Pregnancy or breastfeeding&#xD;
&#xD;
          -  Persons benefiting from enhanced protection, namely minors, persons deprived of their&#xD;
             liberty by a judicial or administrative decision, persons staying in a health or&#xD;
             social institution, adults under legal protection&#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>Rémi Coudroy, M.D.</last_name>
    <role>Study Director</role>
    <affiliation>Poitiers University Hospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86000</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Coudroy R, Frat JP, Ehrmann S, Pene F, Terzi N, Decavele M, Prat G, Garret C, Contou D, Bourenne J, Gacouin A, Girault C, Dellamonica J, Malacrino D, Labro G, Quenot JP, Herbland A, Jochmans S, Devaquet J, Benzekri D, Vivier E, Nseir S, Colin G, Thevenin D, Grasselli G, Assefi M, Guerin C, Bougon D, Lherm T, Kouatchet A, Ragot S, Thille AW; REVA Network. High-flow nasal oxygen therapy alone or with non-invasive ventilation in immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure: the randomised multicentre controlled FLORALI-IM protocol. BMJ Open. 2019 Aug 10;9(8):e029798. doi: 10.1136/bmjopen-2019-029798.</citation>
    <PMID>31401603</PMID>
  </reference>
  <verification_date>September 2019</verification_date>
  <study_first_submitted>November 24, 2016</study_first_submitted>
  <study_first_submitted_qc>November 28, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 30, 2016</study_first_posted>
  <last_update_submitted>September 2, 2019</last_update_submitted>
  <last_update_submitted_qc>September 2, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">September 4, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Insufficiency</mesh_term>
    <mesh_term>Respiratory Distress Syndrome</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/NCT02978300
org study id: 2016-A00834-47
nct id: NCT02978300
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Acute respiratory failure is the leading cause of ICU admission of immunocompromized
      patients. In this subgroup of patients, the need for intubation and invasive mechanical
      ventilation occurs in about 50% of cases and is associated with very a high mortality rate,
      reaching 70% of cases. Therefore, noninvasive oxygenation strategies have been developed to
      avoid intubation.

      More than 15 years ago, 2 trials have suggested that NIV could decrease intubation and
      mortality rates of immunocompromized patients as compared to standard oxygen through a mask.
      However these results have not been confirmed in a recent large trial.

      HFNC is a recent and well-tolerated oxygenation technique. In a recent trial, HFNC alone
      could decrease mortality and intubation rates in patients with ARF as compared to NIV.
      Similar findings have been reported in a post-hoc analysis on immunocompromized patients
      excluding those with profound neutropenia. Likewise in a retrospective monocentric cohort of
      immunocompromized patients, we reported better outcomes with HFNC than with NIV.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: mortality rates
time frame: day 28
description: Mortality rates at day 28 after randomization will be compared between the 2 groups
arm group label: NIV/HFNC group
arm group type: Active Comparator
description: Continuous NIV for at least 4 hours until clinical improvement then intermittent 1-hour sessions for a minimal duration of 12 hours a day. Between NIV sessions HFNC will be delivered as in the HFNC group.
arm group label: HFNC group
arm group type: Experimental
description: Continuous HFNC alone 24h/24 until weaning or intubation.
intervention type: Device
intervention name: NIV/HFNC
description: Pressure support level to achieve an expired tidal volume between 6 and 8 ml/kg of predicted body weight Positive end expiratory pressure from 5 to 10 cm H2O, aiming a PEEP level ≥ 8 cm H2O FiO2 set to achieve SpO2 ≥ 92%
arm group label: NIV/HFNC group
intervention type: Device
intervention name: HFNC
description: Gas flow of 60 l/min and FiO2 set to achieve SpO2 ≥ 92%
arm group label: HFNC group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Rémi Coudroy, M.D.
role: Study Director
affiliation: Poitiers University Hospital
facility: 
country: France
citation: Coudroy R, Frat JP, Ehrmann S, Pene F, Terzi N, Decavele M, Prat G, Garret C, Contou D, Bourenne J, Gacouin A, Girault C, Dellamonica J, Malacrino D, Labro G, Quenot JP, Herbland A, Jochmans S, Devaquet J, Benzekri D, Vivier E, Nseir S, Colin G, Thevenin D, Grasselli G, Assefi M, Guerin C, Bougon D, Lherm T, Kouatchet A, Ragot S, Thille AW; REVA Network. High-flow nasal oxygen therapy alone or with non-invasive ventilation in immunocompromised patients admitted to ICU for acute hypoxemic respiratory failure: the randomised multicentre controlled FLORALI-IM protocol. BMJ Open. 2019 Aug 10;9(8):e029798. doi: 10.1136/bmjopen-2019-029798.
PMID: 31401603
responsible party type: Sponsor
mesh term: Respiratory Insufficiency
mesh term: Respiratory Distress Syndrome
sharing ipd: Undecided