<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/NCT03018483</url>
  </required_header>
  <id_info>
    <org_study_id>PSWEAN and EIT</org_study_id>
    <nct_id>NCT03018483</nct_id>
  </id_info>
  <brief_title>Mechanical Ventilation- Weaning and Thoracic Impedance Tomography</brief_title>
  <official_title>Comparison Between Automated Pressure Support Ventilation, Variable Pressure Support Ventilation and Non-variable Pressure Support Ventilation in Weaning From Mechanical Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Federico II University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Federico II University</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 aim of this multicenter, randomized controlled trial is to evaluate the weaning time from&#xD;
      mechanical ventilation comparing non-variable PSV, variable PSV, and Smart CareTM.&#xD;
&#xD;
      This study is a multicenter randomized controlled open trial comparing variable, non-variable&#xD;
      pressure support ventilation and Smart CareTM in patients receiving mechanical ventilation&#xD;
      for more than 24 hours who are able to be weaned.&#xD;
&#xD;
      The aim of the study is to determine the duration of weaning from mechanical ventilation for&#xD;
      each one of the above mentioned weaning methods&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 1, 2017</start_date>
  <completion_date type="Anticipated">December 1, 2019</completion_date>
  <primary_completion_date type="Actual">May 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>weaning time</measure>
    <time_frame>within 6 hours</time_frame>
    <description>weaning time defined as the time from randomization to successful extubation.</description>
  </primary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">342</enrollment>
  <condition>Weaning From Mechanical Ventilation</condition>
  <arm_group>
    <arm_group_label>Variable PSV</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional PSV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>Automated PSV</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>NAVA</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Variable PSV</intervention_name>
    <description>Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O.&#xD;
In patients ventilated with variable PSV, the pressure support variability is as high as possible (up to 100%), while not exceeding the maximal inspiratory pressure determined by the treating physician.</description>
    <arm_group_label>Variable PSV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Conventional PSV</intervention_name>
    <description>Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O. The adjustment of pressure support until extubation follows these rules for both non-variable and variable PSV groups: pressure support is gradually adjusted in decrements (or increments) of 0 to 5 cmH2O. PEEP is decreased in steps of 0 to 5 cmH2O; PEEP and FiO2 are adjusted to achieve a SaO2 ≥92%, with a PEEP ≥5 cmH2O.</description>
    <arm_group_label>Conventional PSV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Automated PSV</intervention_name>
    <description>Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O.Smart CareTM as total automated procedure will be used.</description>
    <arm_group_label>Automated PSV</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>NAVA</intervention_name>
    <description>NAVA level is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the Edi level was increased by step of 0,2 cm/h2o/ mcvolt, PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O.</description>
    <arm_group_label>NAVA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age≥18 years&#xD;
&#xD;
          -  duration of controlled mechanical ventilation≥ 24 h&#xD;
&#xD;
          -  temperature≤ 39°C&#xD;
&#xD;
          -  hemoglobin≥ 6 g/dl&#xD;
&#xD;
          -  ratio of arterial partial pressure of oxygen to inspiratory oxygen fraction -&#xD;
             PaO2/FiO2≥150mmHg with positive end-expiratory pressure (PEEP)≤ 16 cmH2O&#xD;
&#xD;
          -  ability of the patient to breathe spontaneously&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient participated in another interventional trial within the last four weeks before&#xD;
             enrollment&#xD;
&#xD;
          -  peripheral neurological disease associated with impairment of the respiratory pump&#xD;
&#xD;
          -  muscular disease associated with impairment of the respiratory pump&#xD;
&#xD;
          -  unstable thorax with paradoxical chest wall movement&#xD;
&#xD;
          -  planned surgery under general anesthesia within 72 hours&#xD;
&#xD;
          -  difficult airway or intubation&#xD;
&#xD;
          -  existing tracheotomy at ICU admission&#xD;
&#xD;
          -  expected survival&lt;72 hours&#xD;
&#xD;
          -  home mechanical ventilation or on chronic oxygen therapy&#xD;
&#xD;
          -  suspected or confirmed pregnancy&#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>Maria Vargas</last_name>
    <phone>+39 3396876440</phone>
    <email>vargas.maria82@gmail.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>University of Naples</name>
      <address>
        <city>Naples</city>
        <zip>80100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>maria vargas, MD</last_name>
      <email>vargas.maria82@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>January 4, 2017</study_first_submitted>
  <study_first_submitted_qc>January 10, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 12, 2017</study_first_posted>
  <last_update_submitted>December 8, 2019</last_update_submitted>
  <last_update_submitted_qc>December 8, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Federico II University</investigator_affiliation>
    <investigator_full_name>Maria Vargas</investigator_full_name>
    <investigator_title>Resercher</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>No</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/NCT03018483
org study id: PSWEAN and EIT
nct id: NCT03018483
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this multicenter, randomized controlled trial is to evaluate the weaning time from
      mechanical ventilation comparing non-variable PSV, variable PSV, and Smart CareTM.

      This study is a multicenter randomized controlled open trial comparing variable, non-variable
      pressure support ventilation and Smart CareTM in patients receiving mechanical ventilation
      for more than 24 hours who are able to be weaned.

      The aim of the study is to determine the duration of weaning from mechanical ventilation for
      each one of the above mentioned weaning methods
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: weaning time
time frame: within 6 hours
description: weaning time defined as the time from randomization to successful extubation.
arm group label: Variable PSV
arm group type: Experimental
arm group label: Conventional PSV
arm group type: Active Comparator
arm group label: Automated PSV
arm group type: Active Comparator
arm group label: NAVA
arm group type: Active Comparator
intervention type: Device
intervention name: Variable PSV
description: Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O.
In patients ventilated with variable PSV, the pressure support variability is as high as possible (up to 100%), while not exceeding the maximal inspiratory pressure determined by the treating physician.
arm group label: Variable PSV
intervention type: Device
intervention name: Conventional PSV
description: Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O. The adjustment of pressure support until extubation follows these rules for both non-variable and variable PSV groups: pressure support is gradually adjusted in decrements (or increments) of 0 to 5 cmH2O. PEEP is decreased in steps of 0 to 5 cmH2O; PEEP and FiO2 are adjusted to achieve a SaO2 ≥92%, with a PEEP ≥5 cmH2O.
arm group label: Conventional PSV
intervention type: Device
intervention name: Automated PSV
description: Pressure support is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the flow trigger is set at 2 l/min; inspiratory cycling-off at 25% of peak flow; PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O.Smart CareTM as total automated procedure will be used.
arm group label: Automated PSV
intervention type: Device
intervention name: NAVA
description: NAVA level is to a targeted mean tidal volume of 6 to 8 ml/kg; the maximal inspiratory pressure ≤40 cmH2O; the Edi level was increased by step of 0,2 cm/h2o/ mcvolt, PEEP and FiO2 for oxygen saturation SaO2 ≥92%, with PEEP ≥5 cmH2O.
arm group label: NAVA
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maria Vargas
phone: +39 3396876440
email: vargas.maria82@gmail.com
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Federico II University
investigator full name: Maria Vargas
investigator title: Resercher
sharing ipd: No