xml: <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/NCT06008587</url>
    </required_header>
    <id_info>
      <org_study_id>2022-CHITS-012</org_study_id>
      <secondary_id>2022-A02641-42</secondary_id>
      <nct_id>NCT06008587</nct_id>
    </id_info>
    <brief_title>Contribution of Nasal High Flow in Pneumology Assessed in Acid-Free Hypercapnic Acute Respiratory Failure</brief_title>
    <acronym>PIRAHNA</acronym>
    <official_title>Contribution of Nasal High Flow in Pneumology Assessed in Acid-Free Hypercapnic Acute Respiratory Failure</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Centre Hospitalier Intercommunal de Toulon La Seyne sur Mer</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 hypothesis is that Nasal High Flow therapy for patients with Hypercapnic Acute&#xD;
        Respiratory Failure without acidosis, in addition to standard treatment would improve the&#xD;
        care.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of the PIRAHNA study is to compare patients treated with Nasal High Flow in&#xD;
        association with conventional standard treatment versus patients treated only with&#xD;
        conventional standard treatment.&#xD;
  &#xD;
        Primary objective : To demonstrate the therapeutic superiority of Nasal High Flow in&#xD;
        hypercapnic Acute Respiratory Failure without acidosis, in combination with conventional&#xD;
        standard treatment&#xD;
  &#xD;
        Secondary objectives :&#xD;
  &#xD;
          1. Identify the characteristics (etiologies) of responder patients (defined by a decrease&#xD;
             in capnia and a failure to develop acidosis within two weeks of hospitalization)&#xD;
  &#xD;
          2. Identify the etiology (trigger) of the Acute Respiratory Failure of responder patients&#xD;
  &#xD;
          3. Compare the evolution of respiratory rate between the two treatment groups&#xD;
  &#xD;
          4. Compare the evolution of dyspnea between the two treatment groups&#xD;
  &#xD;
          5. Compare the evolution of gas exchanges between the two treatment groups&#xD;
  &#xD;
          6. Compare the length of stay between the two groups&#xD;
  &#xD;
          7. Compare the evolution of patients comfort state in the two treatment groups&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</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>Failure of the Nasal High Flow</measure>
      <time_frame>Up to 2 weeks</time_frame>
      <description>Failure of the Nasal High Flow is defined by the occurrence of respiratory acidosis (pH&lt;7.35) within 2 weeks after admission</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Responding patients phenotype</measure>
      <time_frame>At Day 30 after hospital discharge</time_frame>
      <description>Phenotype will be characterized by the presence of one or more of the following elements : obesity hypoventilation syndrome, chronic obstructive pulmonary disease (COPD) emphysema, thoracic enlargement, bronchiectasis.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Etiology of acute respiratory failure</measure>
      <time_frame>Up to 2 weeks</time_frame>
      <description>The triggers of acute respiratory failure will be assessed : bacterial secondary infection, viral infection, bronchospasm, ...</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Respiratory rate</measure>
      <time_frame>Up to 2 weeks</time_frame>
      <description>Respiratory rate will be recorded from Day 0 to Day 15, or until discharge (if less than 15 days).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Dyspnea</measure>
      <time_frame>Up to 2 weeks</time_frame>
      <description>Dyspnea will be assessed by the modified Borg scale rating of perceived exertion (RPE) from Day 0 to Day 15.&#xD;
  The minimum value of the scale corresponding to no shortness of breath is 0 and the maximum value corresponding to dyspnea is 10. Higher score means a worse outcome.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pH</measure>
      <time_frame>Up to 2 weeks</time_frame>
      <description>pH will be assessed from Day 0 to Day 15.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Partial Pressure of Carbon dioxide (PCO2)</measure>
      <time_frame>Up to 2 weeks</time_frame>
      <description>PCO2 will be assessed from Day 0 to Day 15.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Bicarbonates</measure>
      <time_frame>Up to 2 weeks</time_frame>
      <description>HCO3- will be assessed from Day 0 to Day 15.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>pCO2 normalization time</measure>
      <time_frame>Up to 2 weeks</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>ROX index</measure>
      <time_frame>Up to 2 weeks</time_frame>
      <description>ROX index will be performed from Day 0 to Day 15.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of hospital stay</measure>
      <time_frame>Up to 2 weeks</time_frame>
      <description>Duration will be recorded in days medically necessary in the pneumology department</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Comfort Visual Analogic Scale (VAS)</measure>
      <time_frame>Up to 2 weeks</time_frame>
      <description>Patient's comfort will be assessed on a Visual Analogic Scale at Day 0, Day 7 and Day 15 or at hospital discharge.&#xD;
  The minimum value of the scale, corresponding to no discomfort is 0 and the maximum value corresponding to the maximum discomfort, is 10. Higher score means a worse outcome.</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">126</enrollment>
    <condition>Respiratory Insufficiency</condition>
    <arm_group>
      <arm_group_label>Nasal High Flow therapy in association with the standard therapy</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Standard therapy alone</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>AIRVO3 TM</intervention_name>
      <description>A device that provides high flows of heated and humidified respiratory gases to patient who breath spontaneously. Patients will be treated with the device up to 15 days or until the occurrence of respiratory acidosis defined by pH&lt;7.35, whichever come first.</description>
      <arm_group_label>Nasal High Flow therapy in association with the standard therapy</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Standard therapy</intervention_name>
      <description>Standard therapy depends on the acute respiratory failure etiology. Treatments will be administered at the investigator's discretion in accordance with the standard of care.</description>
      <arm_group_label>Nasal High Flow therapy in association with the standard therapy</arm_group_label>
      <arm_group_label>Standard therapy alone</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Major patient ≥ 18 years old&#xD;
  &#xD;
            -  Medical diagnosis of Acute Respiratory Failure less than 24 hours&#xD;
  &#xD;
            -  With partial pressure of carbon dioxide (PaCO2) ≥ 45 and pH &gt; 7.35 for less than&#xD;
               24hours, with no indication of Non-Invasive Ventilation (NIV) placement&#xD;
  &#xD;
            -  Underlying terrain of known or unknown chronic respiratory pathology (may be unknown&#xD;
               at time of diagnosis) Examples : COPD, Bronchiectasis, Pulmonary fibrosis, asthma,&#xD;
               sequelae pathologies …&#xD;
  &#xD;
            -  All etiologies (infectious, cardiac decompensation, trauma, etc.)&#xD;
  &#xD;
            -  Having given informed consent&#xD;
  &#xD;
            -  Patient under a social security scheme&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Restrictive chronic neuromuscular or kyphoscoliotic respiratory insufficiencies&#xD;
  &#xD;
            -  Drug-induced Acute respiratory failure&#xD;
  &#xD;
            -  Pneumothorax (X-ray pulmonary detachment)&#xD;
  &#xD;
            -  Oxygen poisoning (Peripheral oxygen saturation (SpO2) ≥95%)&#xD;
  &#xD;
            -  Severe Acute Respiratory Syndrome (SARS) Coronavirus 2 (COVII) Pneumonia&#xD;
  &#xD;
            -  Tracheostomy&#xD;
  &#xD;
            -  Prior treatment with chronic or initiated NIV just prior to treatment (e.g. Intensive&#xD;
               Care Unit)&#xD;
  &#xD;
            -  Respiratory Severity Criteria for Resuscitation Management&#xD;
  &#xD;
            -  Agitation or non-cooperation&#xD;
  &#xD;
            -  Pregnancy or breastfeeding&#xD;
  &#xD;
            -  Person participating in other biomedical research&#xD;
  &#xD;
            -  Any other reason that the investigator believes may interfere with the evaluation of&#xD;
               the study objectives&#xD;
  &#xD;
            -  Person under judicial protection (guardianship, curatorship)&#xD;
  &#xD;
            -  Person deprived of 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>Cécile MAINCENT, MD</last_name>
      <role>Study Director</role>
      <affiliation>Centre Hospitalier Princesse Grace</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Magali CESANA</last_name>
      <phone>0494145525</phone>
      <phone_ext>+33</phone_ext>
      <email>magali.cesana@ch-toulon.fr</email>
    </overall_contact>
    <location>
      <facility>
        <name>Centre Hospitalier de Cannes</name>
        <address>
          <city>Cannes</city>
          <state>Alpes Maritime</state>
          <zip>06400</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Fabien ROLLAND, MD</last_name>
        <phone>0493697860</phone>
        <phone_ext>+33</phone_ext>
        <email>f.rolland@ch-cannes.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Centre Hospitalier Intercommunal de Toulon- La Seyne sur Mer - Hôpital Sainte Musse</name>
        <address>
          <city>Toulon</city>
          <state>Var</state>
          <zip>83100</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Julien MERRIEN, MD</last_name>
        <phone>0494145000</phone>
        <phone_ext>+33</phone_ext>
        <email>julien.merrien@ch-toulon.fr</email>
      </contact>
    </location>
    <location>
      <facility>
        <name>Centre Hospitalier Princesse Grace</name>
        <address>
          <city>Monaco</city>
          <zip>98000</zip>
          <country>Monaco</country>
        </address>
      </facility>
      <contact>
        <last_name>Cécile MAINCENT, MD</last_name>
        <phone>097989741</phone>
        <phone_ext>+377</phone_ext>
        <email>cecile.maincent@chpg.mc</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
      <country>Monaco</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 23, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 23, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Nasal High Flow</keyword>
    <keyword>Acute Respiratory Failure</keyword>
    <keyword>Respiratory non-acidosis</keyword>
    <keyword>Pneumology</keyword>
    <keyword>Hypercapnia</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>
  
  
text: 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/NCT06008587
  org study id: 2022-CHITS-012
  secondary id: 2022-A02641-42
  nct id: NCT06008587
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The hypothesis is that Nasal High Flow therapy for patients with Hypercapnic Acute
        Respiratory Failure without acidosis, in addition to standard treatment would improve the
        care.
  The aim of the PIRAHNA study is to compare patients treated with Nasal High Flow in
        association with conventional standard treatment versus patients treated only with
        conventional standard treatment.
  
        Primary objective : To demonstrate the therapeutic superiority of Nasal High Flow in
        hypercapnic Acute Respiratory Failure without acidosis, in combination with conventional
        standard treatment
  
        Secondary objectives :
  
          1. Identify the characteristics (etiologies) of responder patients (defined by a decrease
             in capnia and a failure to develop acidosis within two weeks of hospitalization)
  
          2. Identify the etiology (trigger) of the Acute Respiratory Failure of responder patients
  
          3. Compare the evolution of respiratory rate between the two treatment groups
  
          4. Compare the evolution of dyspnea between the two treatment groups
  
          5. Compare the evolution of gas exchanges between the two treatment groups
  
          6. Compare the length of stay between the two groups
  
          7. Compare the evolution of patients comfort state in the two treatment groups
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Failure of the Nasal High Flow
  time frame: Up to 2 weeks
  description: Failure of the Nasal High Flow is defined by the occurrence of respiratory acidosis (pH<7.35) within 2 weeks after admission
  measure: Responding patients phenotype
  time frame: At Day 30 after hospital discharge
  description: Phenotype will be characterized by the presence of one or more of the following elements : obesity hypoventilation syndrome, chronic obstructive pulmonary disease (COPD) emphysema, thoracic enlargement, bronchiectasis.
  measure: Etiology of acute respiratory failure
  time frame: Up to 2 weeks
  description: The triggers of acute respiratory failure will be assessed : bacterial secondary infection, viral infection, bronchospasm, ...
  measure: Respiratory rate
  time frame: Up to 2 weeks
  description: Respiratory rate will be recorded from Day 0 to Day 15, or until discharge (if less than 15 days).
  measure: Dyspnea
  time frame: Up to 2 weeks
  description: Dyspnea will be assessed by the modified Borg scale rating of perceived exertion (RPE) from Day 0 to Day 15.
  The minimum value of the scale corresponding to no shortness of breath is 0 and the maximum value corresponding to dyspnea is 10. Higher score means a worse outcome.
  measure: pH
  time frame: Up to 2 weeks
  description: pH will be assessed from Day 0 to Day 15.
  measure: Partial Pressure of Carbon dioxide (PCO2)
  time frame: Up to 2 weeks
  description: PCO2 will be assessed from Day 0 to Day 15.
  measure: Bicarbonates
  time frame: Up to 2 weeks
  description: HCO3- will be assessed from Day 0 to Day 15.
  measure: pCO2 normalization time
  time frame: Up to 2 weeks
  measure: ROX index
  time frame: Up to 2 weeks
  description: ROX index will be performed from Day 0 to Day 15.
  measure: Length of hospital stay
  time frame: Up to 2 weeks
  description: Duration will be recorded in days medically necessary in the pneumology department
  measure: Comfort Visual Analogic Scale (VAS)
  time frame: Up to 2 weeks
  description: Patient's comfort will be assessed on a Visual Analogic Scale at Day 0, Day 7 and Day 15 or at hospital discharge.
  The minimum value of the scale, corresponding to no discomfort is 0 and the maximum value corresponding to the maximum discomfort, is 10. Higher score means a worse outcome.
  arm group label: Nasal High Flow therapy in association with the standard therapy
  arm group type: Experimental
  arm group label: Standard therapy alone
  arm group type: Active Comparator
  intervention type: Device
  intervention name: AIRVO3 TM
  description: A device that provides high flows of heated and humidified respiratory gases to patient who breath spontaneously. Patients will be treated with the device up to 15 days or until the occurrence of respiratory acidosis defined by pH<7.35, whichever come first.
  arm group label: Nasal High Flow therapy in association with the standard therapy
  intervention type: Other
  intervention name: Standard therapy
  description: Standard therapy depends on the acute respiratory failure etiology. Treatments will be administered at the investigator's discretion in accordance with the standard of care.
  arm group label: Nasal High Flow therapy in association with the standard therapy
  arm group label: Standard therapy alone
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  last name: Cécile MAINCENT, MD
  role: Study Director
  affiliation: Centre Hospitalier Princesse Grace
  last name: Magali CESANA
  phone: 0494145525
  phone ext: +33
  email: magali.cesana@ch-toulon.fr
  facility: 
  contact: 
  facility: 
  contact: 
  facility: 
  contact: 
  country: France
  country: Monaco
  responsible party type: Sponsor
  mesh term: Respiratory Insufficiency