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/NCT06039215</url>
    </required_header>
    <id_info>
      <org_study_id>APHP191098</org_study_id>
      <secondary_id>2022-A02716-37</secondary_id>
      <nct_id>NCT06039215</nct_id>
    </id_info>
    <brief_title>Paramedical Protocol for Ventilation in Acute Respiratory Distress Syndrome</brief_title>
    <acronym>PARAVENT</acronym>
    <official_title>Paramedical Protocol for Ventilation in Acute Respiratory Distress Syndrome: Prospective, Multicenter, Randomized, Controlled, Open-label, Phase III, Cluster Trial With Sequential Permutation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</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>
        Acute respiratory distress syndrome (ARDS) is a frequent pathology in intensive care (around&#xD;
        10% of patients admitted to intensive care and almost a quarter of patients on mechanical&#xD;
        ventilation) and a serious one, with a hospital mortality rate of 40%. The main measures that&#xD;
        have an effect on mortality in ARDS involve adjustments to the ventilator, known as&#xD;
        protective ventilation. In the most severe patients, adjuvant measures such as prone&#xD;
        positioning and the use of curarisation in the initial phase of the disease can improve&#xD;
        survival. All these measures have been included in the latest national and international&#xD;
        recommendations. However, a vast observational study carried out in 50 countries revealed low&#xD;
        compliance with these recommendations. More than a third of patients did not receive&#xD;
        protective ventilation, and the majority did not receive prone positioning when this was&#xD;
        indicated. During weaning from artificial ventilation, it has been widely demonstrated that&#xD;
        replacing clinician judgement with the implementation of paramedical care protocols improved&#xD;
        weaning and significantly reduced the duration of artificial ventilation. Therefore,&#xD;
        investigators hypothesize that the implementation of a paramedical care protocol for&#xD;
        ventilation in the acute phase of ARDS improves compliance with recommendations and thus&#xD;
        reduces mortality and the duration of artificial ventilation. However, implementation of such&#xD;
        a protocol requires operational training for all the nurses in the participating departments.&#xD;
        Simulation appears to be the training method of choice, as it is a teaching technique that&#xD;
        enables technical and non-technical skills to be passed on with good retention of what has&#xD;
        been learnt, as well as assessing what has been learnt. To make it possible to train several&#xD;
        dozen nurses within a tight timescale, a partially dematerialized simulation model&#xD;
        incorporating innovative e-learning tools will be developed.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 1, 2023</start_date>
    <completion_date type="Anticipated">August 1, 2025</completion_date>
    <primary_completion_date type="Anticipated">August 1, 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>Sequential Assignment</intervention_model>
      <intervention_model_description>This is a prospective, multicenter, randomized, controlled, open-label, phase III, stepped wedge cluster randomized design. This experimental design involves the sequential implementation of an intervention in the clusters included over several periods. The order in which the clusters received the intervention was determined by drawing lots; at the end of the study, all the clusters received the intervention at some point and were observed during a pre- and post-intervention control period (each cluster &quot;is its own control&quot;).</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Mortality rate and number of days without mechanical ventilation</measure>
      <time_frame>28 days</time_frame>
      <description>The primary endpoint will be a combination of mortality and the number of days without mechanical ventilation at D28. This composite criterion will be prioritised so that survival is given priority in the analysis over the shorter duration of mechanical ventilation.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Mesure of tidal volume ventilation</measure>
      <time_frame>Up to Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mesure of plateau pressure</measure>
      <time_frame>Up to Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mesure of positive end-expiratory pressure (PEEP)</measure>
      <time_frame>Up to Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mesure of FiO2</measure>
      <time_frame>Up to Day 7</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Oxygenation</measure>
      <time_frame>Up to Day 7</time_frame>
      <description>arterial blood gases and SpO2</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of days without mechanical ventilation</measure>
      <time_frame>Up to Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of days without catecholamine</measure>
      <time_frame>Up to Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of days without continuous sedation</measure>
      <time_frame>Up to Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of mechanical ventilation .</measure>
      <time_frame>Up to Day 28</time_frame>
      <description>from intubation to successful extubation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Occurrence of mechanically ventilated pneumothorax</measure>
      <time_frame>Up to Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of Acute respiratory distress syndrome</measure>
      <time_frame>UP to Day 28</time_frame>
      <description>defined as the day on which the 1st test of spontaneous ventilation was performed</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Duration of weaning from mechanical ventilation</measure>
      <time_frame>Up to Day 28</time_frame>
      <description>measured as the time between the 1st test of spontaneous ventilation and successful extubation (patient alive and without reintubation within 7 days of extubation).</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of participants with rescue therapy</measure>
      <time_frame>Up to Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of re-intubation</measure>
      <time_frame>Up to Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Rate of use of non-invasive ventilation and curative high-flow oxygen therapy</measure>
      <time_frame>Up to Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tracheostomy rate</measure>
      <time_frame>Up to Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Length of stay in intensive care and in hospital.</measure>
      <time_frame>Up to day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of deaths in ICU and hospital</measure>
      <time_frame>Up to Day 28</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Number of nurses trained in paramedical protocol per center.</measure>
      <time_frame>Up to 26 months</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">540</enrollment>
    <condition>Acute Respiratory Distress Syndrome</condition>
    <arm_group>
      <arm_group_label>Experimental group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Respirator settings are adjusted by nurses according to a pre-established care protocol that complies with international recommendations. The nurse assesses the patient's respiratory status and readjusts the artificial respirator settings if necessary, at least twice a day.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>The ventilator settings are adjusted in line with the centre's usual practice. No change from usual management of acute respiratory distress syndrome.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Ventilatory adjustments by nurses</intervention_name>
      <description>Respirator settings are adjusted by nurses according to a pre-established care protocol that complies with international recommendations. The nurse assesses the patient's respiratory status and readjusts the artificial respirator settings if necessary, at least twice a day.</description>
      <arm_group_label>Experimental group</arm_group_label>
      <other_name>Post-intervention period</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Age ≥ 18 years&#xD;
  &#xD;
            -  Intensive care hospitalization;&#xD;
  &#xD;
            -  Intubation with artificial ventilation;&#xD;
  &#xD;
            -  ARDS evolving for less than 72 hours. ARDS criteria according to the Berlin&#xD;
               definition, as follows:&#xD;
  &#xD;
                 -  Exposure to a risk factor for ARDS or onset/aggravation of pulmonary symptoms&#xD;
                    within the previous 7 days ;&#xD;
  &#xD;
                 -  Respiratory distress not fully explained by cardiac failure or volume overload,&#xD;
                    with exclusion of hydrostatic edema in the absence of exposure to a risk factor&#xD;
                    for ARDS;&#xD;
  &#xD;
                 -  Hypoxemia with PaO2/FiO2 ratio &lt; 300 mm Hg under PEEP ≥ 5 cmH2O ;&#xD;
  &#xD;
                 -  Bilateral opacities on chest X-ray, lung ultrasound or chest CT, not fully&#xD;
                    explained by pleural effusions, atelectasis or nodules.&#xD;
  &#xD;
            -  Blood pressure monitoring&#xD;
  &#xD;
            -  Affiliation to the social security system.&#xD;
  &#xD;
            -  Written informed consent (patient, relative) or inclusion in emergency situation.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Long-term oxygen therapy;&#xD;
  &#xD;
            -  Pneumothorax or drained pleurisy;&#xD;
  &#xD;
            -  Documented pulmonary embolism;&#xD;
  &#xD;
            -  Intracranial hypertension;&#xD;
  &#xD;
            -  ARDS refractory to inclusion, i.e.: i) oxygen partial pressure on inspired oxygen&#xD;
               fraction a ratio (PaO2/FiO2) &lt;80 mm Hg or plateau pressure (Pplat) &gt; 32 cmH2O despite&#xD;
               optimization of mechanical ventilation (tidal volume (Vt) set at 6 mL/kg weight&#xD;
               predicted by height, FiO2 ≥80% and positive expiratory pressure (PEEP) ≥10 cmH2O) and&#xD;
               despite the use of complementary therapies (including prone and/or inhaled nitric&#xD;
               oxide); or ii) pH &lt;7. 25 with PaCO2 ≥60 mm Hg;&#xD;
  &#xD;
            -  ARDS evolving for more than 72 hours with intubation and mechanical ventilation;&#xD;
  &#xD;
            -  Patient deprived of liberty;&#xD;
  &#xD;
            -  Patient under legal protection (guardianship or curatorship);&#xD;
  &#xD;
            -  Known pregnancy or breast-feeding (a pregnancy test will be performed prior to&#xD;
               inclusion in patients of childbearing age).&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Assistance Publique-Hôpitaux de Paris service de santé publique</name>
        <address>
          <city>Créteil</city>
          <state>Creteil</state>
          <zip>94010</zip>
          <country>France</country>
        </address>
      </facility>
      <contact>
        <last_name>Assistance Publique-Hôpitaux de Paris service de santé publique</last_name>
        <phone>0145178638</phone>
        <email>samia.baloul@aphp.fr</email>
      </contact>
    </location>
    <location_countries>
      <country>France</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>July 12, 2023</study_first_submitted>
    <study_first_submitted_qc>September 8, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 15, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 15, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Acute respiratory distress syndrome</keyword>
    <keyword>ARDS</keyword>
    <keyword>Paramedical care protocol</keyword>
    <keyword>Mortality</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Respiratory Distress Syndrome</mesh_term>
      <mesh_term>Respiratory Distress Syndrome, Newborn</mesh_term>
      <mesh_term>Acute Lung Injury</mesh_term>
      <mesh_term>Syndrome</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION</ipd_description>
    </patient_data>
    <!-- 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/NCT06039215
  org study id: APHP191098
  secondary id: 2022-A02716-37
  nct id: NCT06039215
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  Acute respiratory distress syndrome (ARDS) is a frequent pathology in intensive care (around
        10% of patients admitted to intensive care and almost a quarter of patients on mechanical
        ventilation) and a serious one, with a hospital mortality rate of 40%. The main measures that
        have an effect on mortality in ARDS involve adjustments to the ventilator, known as
        protective ventilation. In the most severe patients, adjuvant measures such as prone
        positioning and the use of curarisation in the initial phase of the disease can improve
        survival. All these measures have been included in the latest national and international
        recommendations. However, a vast observational study carried out in 50 countries revealed low
        compliance with these recommendations. More than a third of patients did not receive
        protective ventilation, and the majority did not receive prone positioning when this was
        indicated. During weaning from artificial ventilation, it has been widely demonstrated that
        replacing clinician judgement with the implementation of paramedical care protocols improved
        weaning and significantly reduced the duration of artificial ventilation. Therefore,
        investigators hypothesize that the implementation of a paramedical care protocol for
        ventilation in the acute phase of ARDS improves compliance with recommendations and thus
        reduces mortality and the duration of artificial ventilation. However, implementation of such
        a protocol requires operational training for all the nurses in the participating departments.
        Simulation appears to be the training method of choice, as it is a teaching technique that
        enables technical and non-technical skills to be passed on with good retention of what has
        been learnt, as well as assessing what has been learnt. To make it possible to train several
        dozen nurses within a tight timescale, a partially dematerialized simulation model
        incorporating innovative e-learning tools will be developed.
  allocation: Randomized
  intervention model: Sequential Assignment
  intervention model description: This is a prospective, multicenter, randomized, controlled, open-label, phase III, stepped wedge cluster randomized design. This experimental design involves the sequential implementation of an intervention in the clusters included over several periods. The order in which the clusters received the intervention was determined by drawing lots; at the end of the study, all the clusters received the intervention at some point and were observed during a pre- and post-intervention control period (each cluster "is its own control").
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Mortality rate and number of days without mechanical ventilation
  time frame: 28 days
  description: The primary endpoint will be a combination of mortality and the number of days without mechanical ventilation at D28. This composite criterion will be prioritised so that survival is given priority in the analysis over the shorter duration of mechanical ventilation.
  measure: Mesure of tidal volume ventilation
  time frame: Up to Day 7
  measure: Mesure of plateau pressure
  time frame: Up to Day 7
  measure: Mesure of positive end-expiratory pressure (PEEP)
  time frame: Up to Day 7
  measure: Mesure of FiO2
  time frame: Up to Day 7
  measure: Oxygenation
  time frame: Up to Day 7
  description: arterial blood gases and SpO2
  measure: Number of days without mechanical ventilation
  time frame: Up to Day 28
  measure: Number of days without catecholamine
  time frame: Up to Day 28
  measure: Number of days without continuous sedation
  time frame: Up to Day 28
  measure: Duration of mechanical ventilation .
  time frame: Up to Day 28
  description: from intubation to successful extubation
  measure: Occurrence of mechanically ventilated pneumothorax
  time frame: Up to Day 28
  measure: Duration of Acute respiratory distress syndrome
  time frame: UP to Day 28
  description: defined as the day on which the 1st test of spontaneous ventilation was performed
  measure: Duration of weaning from mechanical ventilation
  time frame: Up to Day 28
  description: measured as the time between the 1st test of spontaneous ventilation and successful extubation (patient alive and without reintubation within 7 days of extubation).
  measure: Number of participants with rescue therapy
  time frame: Up to Day 28
  measure: Rate of re-intubation
  time frame: Up to Day 28
  measure: Rate of use of non-invasive ventilation and curative high-flow oxygen therapy
  time frame: Up to Day 28
  measure: Tracheostomy rate
  time frame: Up to Day 28
  measure: Length of stay in intensive care and in hospital.
  time frame: Up to day 28
  measure: Number of deaths in ICU and hospital
  time frame: Up to Day 28
  measure: Number of nurses trained in paramedical protocol per center.
  time frame: Up to 26 months
  arm group label: Experimental group
  arm group type: Experimental
  description: Respirator settings are adjusted by nurses according to a pre-established care protocol that complies with international recommendations. The nurse assesses the patient's respiratory status and readjusts the artificial respirator settings if necessary, at least twice a day.
  arm group label: Control group
  arm group type: No Intervention
  description: The ventilator settings are adjusted in line with the centre's usual practice. No change from usual management of acute respiratory distress syndrome.
  intervention type: Other
  intervention name: Ventilatory adjustments by nurses
  description: Respirator settings are adjusted by nurses according to a pre-established care protocol that complies with international recommendations. The nurse assesses the patient's respiratory status and readjusts the artificial respirator settings if necessary, at least twice a day.
  arm group label: Experimental group
  other name: Post-intervention period
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  contact: 
  country: France
  responsible party type: Sponsor
  mesh term: Respiratory Distress Syndrome
  mesh term: Respiratory Distress Syndrome, Newborn
  mesh term: Acute Lung Injury
  mesh term: Syndrome
  sharing ipd: No
  ipd description: DATAS ARE OWN BY ASSISTANCE PUBLIQUE - HOPITAUX DE PARIS, PLEASE CONTACT SPONSOR FOR FURTHER INFORMATION