<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/NCT02259335</url>
  </required_header>
  <id_info>
    <org_study_id>110/2014</org_study_id>
    <nct_id>NCT02259335</nct_id>
  </id_info>
  <brief_title>Weaning Form Mechanical Ventilation Using Extracorporeal CO2 Removal</brief_title>
  <acronym>WeanPRO</acronym>
  <official_title>A Pilot Study on the Use of Extracorporeal CO2 Removal During the Weaning Process From Mechanical Ventilation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>IRCCS Azienda Ospedaliero-Universitaria di Bologna</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Turin, Italy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>IRCCS Azienda Ospedaliero-Universitaria di Bologna</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Weaning from invasive mechanical ventilation is one of the major clinical problem especially&#xD;
      ion those patients with a pre-existing chronic respiratory disease and chronic hypercpania.&#xD;
&#xD;
      The aim of this pilot feasibility and safety trial is to assess the possibility of shorten&#xD;
      the duration of mechanical ventilation using a device able to remove CO2 and theoretically&#xD;
      able to allow therefore the praecox extubation&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Weaning from invasive mechanical ventilation is one of the major clinical problem especially&#xD;
      ion those patients with a pre-existing chronic respiratory disease and chronic hypercpania.&#xD;
      Up to 60% of the ventilatory time is devoted in these patients to the process of weaning.&#xD;
&#xD;
      These patients very often fail several weaning attempt, when a T-piece trial method is used.&#xD;
      In this case they are also very likely to require tracheotomy.&#xD;
&#xD;
      In this study we will enroll those still hypercapnic patients fitting the criteria of&#xD;
      readiness to be wean (i.e. clinical stability, normal sensorium and good cough reflex) and&#xD;
      failing a T-piece trail because of a rise in PaCO2 (&gt;20% from baseline) and/or a rapid&#xD;
      shallow breathing index (f/VT)&gt; 100.&#xD;
&#xD;
      After the unsuccessful trial they will be reconnected to the ventilator and they will repeat&#xD;
      hours later the same T-piece trial once the extracorporeal CO2 removal device (DeCap) will be&#xD;
      connected via a double lumen catheter in the femoral vein.&#xD;
&#xD;
      The investigators aim to verify whether using the DeCap) the investigators will be able to&#xD;
      avoid at the end of the T-piece trial the criteria of failure. If so, the patient will be&#xD;
      extubated and DeCap will be continued when all of the following were achieved for at least 12&#xD;
      hours: respiratory rate less than 25 breaths/min; pH greater than 7.35; Paco2 less than 20%&#xD;
      of the baseline value; and absence of use of the accessory muscles or paradoxical abdominal&#xD;
      movements.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>October 2014</start_date>
  <completion_date type="Anticipated">October 2017</completion_date>
  <primary_completion_date type="Anticipated">April 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>passing a weaning trial using a T-piece method</measure>
    <time_frame>1 hour</time_frame>
    <description>avoiding to reach the criteria of weaning failure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>weaning success</measure>
    <time_frame>48 hours</time_frame>
    <description>avoiding reintubation after removal of DeCap</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Physiological variables (i.e. Arterial Blood Gases, vitals and dyspnea)</measure>
    <time_frame>48 hours</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">15</enrollment>
  <condition>Patients With Acute Hypercapnic Respiratory Failure</condition>
  <arm_group>
    <arm_group_label>patients under invasive ventilation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>those patients failing a T-piece trial beacuse of a PaCO2 rise&gt;20% of baseline and/or a rapid shallow-breathing index &gt;100 will be reconnected to the ventilator Two hours later they will repeat a T-piece trial after connection to the CO2 removal device</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Extracorporeal CO2 removal device</intervention_name>
    <description>A device able to remove CO2 using a dedicated device connected to the patient via a double lumen catheter inserted in the femoral vein</description>
    <arm_group_label>patients under invasive ventilation</arm_group_label>
    <other_name>DeCap</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients meeting the criteria for readiness to be weaned (i.e. clinical stability,&#xD;
             FiO2&lt;50%, normal sensorium, body temperature &lt; 38 and satisfactory cough reflex)&#xD;
&#xD;
          -  Failing a T-piece trial after 1 hour or before for a rise in PaCO2&gt;20% from baseline&#xD;
             and with f/VT ratio &gt;100&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients NOT meeting the criteria for readiness to be weaned&#xD;
&#xD;
          -  Patients succeeding a T-piece trial&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>San'Orsola Malpighi Hospital, Bologna ITALY</name>
      <address>
        <city>Bologna</city>
        <zip>40138</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Stefano Nava, MD</last_name>
      <phone>051 6364017</phone>
      <email>stefano.nava@aosp.bo.it</email>
    </contact>
    <investigator>
      <last_name>Stefano Nava, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Lara Pisani, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Luca Fasano, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
    <investigator>
      <last_name>Nadia Corcione, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>AOU Città della Salute e della Scienza di Torino, Molinette Hospital</name>
      <address>
        <city>Turin</city>
        <zip>10126</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marco V Ranieri, MD</last_name>
      <phone>011633</phone>
      <phone_ext>5500</phone_ext>
      <email>marco.ranieri@unito.it</email>
    </contact>
    <investigator>
      <last_name>Vito Fanelli, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>October 2016</verification_date>
  <study_first_submitted>October 4, 2014</study_first_submitted>
  <study_first_submitted_qc>October 7, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 8, 2014</study_first_posted>
  <last_update_submitted>October 8, 2016</last_update_submitted>
  <last_update_submitted_qc>October 8, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>IRCCS Azienda Ospedaliero-Universitaria di Bologna</investigator_affiliation>
    <investigator_full_name>dr. Stefano Nava</investigator_full_name>
    <investigator_title>Professor of Respiratory Medicine</investigator_title>
  </responsible_party>
  <keyword>weaning from mechanical ventilation</keyword>
  <keyword>extracorporeal CO2 removal</keyword>
  <keyword>post-extubation failure</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>


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/NCT02259335
org study id: 110/2014
nct id: NCT02259335
lead sponsor: 
collaborator: 
has dmc: No
Weaning from invasive mechanical ventilation is one of the major clinical problem especially
      ion those patients with a pre-existing chronic respiratory disease and chronic hypercpania.

      The aim of this pilot feasibility and safety trial is to assess the possibility of shorten
      the duration of mechanical ventilation using a device able to remove CO2 and theoretically
      able to allow therefore the praecox extubation
Weaning from invasive mechanical ventilation is one of the major clinical problem especially
      ion those patients with a pre-existing chronic respiratory disease and chronic hypercpania.
      Up to 60% of the ventilatory time is devoted in these patients to the process of weaning.

      These patients very often fail several weaning attempt, when a T-piece trial method is used.
      In this case they are also very likely to require tracheotomy.

      In this study we will enroll those still hypercapnic patients fitting the criteria of
      readiness to be wean (i.e. clinical stability, normal sensorium and good cough reflex) and
      failing a T-piece trail because of a rise in PaCO2 (>20% from baseline) and/or a rapid
      shallow breathing index (f/VT)> 100.

      After the unsuccessful trial they will be reconnected to the ventilator and they will repeat
      hours later the same T-piece trial once the extracorporeal CO2 removal device (DeCap) will be
      connected via a double lumen catheter in the femoral vein.

      The investigators aim to verify whether using the DeCap) the investigators will be able to
      avoid at the end of the T-piece trial the criteria of failure. If so, the patient will be
      extubated and DeCap will be continued when all of the following were achieved for at least 12
      hours: respiratory rate less than 25 breaths/min; pH greater than 7.35; Paco2 less than 20%
      of the baseline value; and absence of use of the accessory muscles or paradoxical abdominal
      movements.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: passing a weaning trial using a T-piece method
time frame: 1 hour
description: avoiding to reach the criteria of weaning failure
measure: weaning success
time frame: 48 hours
description: avoiding reintubation after removal of DeCap
measure: Physiological variables (i.e. Arterial Blood Gases, vitals and dyspnea)
time frame: 48 hours
arm group label: patients under invasive ventilation
arm group type: Experimental
description: those patients failing a T-piece trial beacuse of a PaCO2 rise>20% of baseline and/or a rapid shallow-breathing index >100 will be reconnected to the ventilator Two hours later they will repeat a T-piece trial after connection to the CO2 removal device
intervention type: Device
intervention name: Extracorporeal CO2 removal device
description: A device able to remove CO2 using a dedicated device connected to the patient via a double lumen catheter inserted in the femoral vein
arm group label: patients under invasive ventilation
other name: DeCap
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
investigator: 
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: IRCCS Azienda Ospedaliero-Universitaria di Bologna
investigator full name: dr. Stefano Nava
investigator title: Professor of Respiratory Medicine
mesh term: Respiratory Insufficiency