<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/NCT04460859</url>
  </required_header>
  <id_info>
    <org_study_id>2027</org_study_id>
    <nct_id>NCT04460859</nct_id>
  </id_info>
  <brief_title>RecruitmEnt Assessed by eleCtRical Impedance Tomography</brief_title>
  <acronym>RECRUIT</acronym>
  <official_title>RecruitmEnt Assessed by eleCtRical Impedance Tomography: Feasibility, Correlation With Clinical oUtcomes and pIloT Data on Personalised PEEP Selection.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Unity Health Toronto</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Unity Health Toronto</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 RECRUIT study is a multinational, multicenter physiological observational study conducted&#xD;
      by the PLUG working group. It is a single-day study (1.5-2 hours) associated with specific&#xD;
      lung (de)recruitment maneuvers to verify the feasibility of measuring the potential for lung&#xD;
      recruitment in mechanically ventilated patients with ARDS by electrical impedance tomography&#xD;
      (EIT).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Despite higher positive end-expiratory pressure (PEEP) being associated with multiple&#xD;
      physiologic benefits, randomized clinical trials comparing higher vs. lower PEEP levels&#xD;
      failed to show improved survival of ARDS patients. Higher PEEP should fully exploit its&#xD;
      benefits only when implemented in patients with higher potential for alveolar recruitment&#xD;
      (i.e., the decrease of non-aerated lung tissue at higher airway pressure) or in patients with&#xD;
      airway closure. Retrospective analysis of randomised clinical trials with PEEP suggests that&#xD;
      when high PEEP is used in responders (oxygenation), survival may be better. Conversely, in&#xD;
      the absence of significant recruitment, higher PEEP should be avoided and lower PEEP might be&#xD;
      recommended.&#xD;
&#xD;
      Titration of PEEP provided by the mechanical ventilator in patients with severe lung injury&#xD;
      should thus be based on bedside information on lung recruitability. However, no valid method&#xD;
      exists to define the best PEEP to optimize recruitment and minimize lung overdistention.&#xD;
      Recruitability varies and is often not assessed. Electrical impedance tomography (EIT) is a&#xD;
      non-invasive bedside imaging technique for measuring the potential for lung recruitment in&#xD;
      ARDS patients. By performing lung (de)recruitment maneuvers and in-depth analyses, we will&#xD;
      define lung recruitability indices and develop methods for real-time and personalized PEEP&#xD;
      selection. This study will prove the feasibility of minimizing risks associated with&#xD;
      inadequate mechanical ventilation by EIT.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 9, 2020</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Anticipated">December 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Other</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Potential for lung recruitment</measure>
    <time_frame>2 hours</time_frame>
    <description>The potential for lung recruitment will be assessed with EIT. Several methods will be used and compared, based on e.g. pixel information of lung aeration, and pressure-volume characteristics at different PEEP steps.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Recruitment-to-inflation (R/I) ratio</measure>
    <time_frame>2 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>EIT-based optimum PEEP level</measure>
    <time_frame>2 hours</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>PEEP level resulting in end-expiratory transpulmonary pressure between 0 and 2 cmH2O</measure>
    <time_frame>2 hours</time_frame>
    <description>For those patients with esophageal pressure measurements available</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Organ dysfunction as per the sequential organ failure assessment (SOFA) score</measure>
    <time_frame>Day 1, 3, 7</time_frame>
    <description>SOFA score min-max: 0-24; a higher score is associated with poor prognosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vital status at ICU discharge, 28 days, and hospital discharge</measure>
    <time_frame>Through study completion, up to 1 year</time_frame>
    <description>Vital status (death/alive) will be assessed via chart review</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ventilator free days</measure>
    <time_frame>Day 28</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">171</enrollment>
  <condition>Acute Respiratory Distress Syndrome (ARDS)</condition>
  <arm_group>
    <arm_group_label>Intubated mechanically ventilated ARDS patients</arm_group_label>
    <description>Intubated mechanically ventilated patients with moderate to severe ARDS according to the Berlin definition</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Specific lung recruitment maneuvers</intervention_name>
    <description>Specific lung recruitment maneuvers will be performed to measure the potential for lung recruitment at different levels of positive end-expiratory pressure (PEEP) provided by the mechanical ventilator. Electrical impedance tomography signals, synchronized signals of airway pressure and flow, esophageal pressure (if available), and volumetric capnography (if available) will be recorded continuously, during the time span of the protocol for offline analysis.</description>
    <arm_group_label>Intubated mechanically ventilated ARDS patients</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Intubated mechanically ventilated patients will be considered for enrolment in the first&#xD;
        week of ARDS diagnosis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Intubated moderate and severe ARDS according to the Berlin definition (PaO2/FiO2 ratio&#xD;
             &lt;= 200 mmHg)&#xD;
&#xD;
          -  Under continuous sedation with or without paralysis&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Bronchopleural fistula&#xD;
&#xD;
          -  Pure COPD exacerbation&#xD;
&#xD;
          -  Contraindication to EIT monitoring (e.g. burns, pacemaker, thoracic wounds limiting&#xD;
             electrode belt placement)&#xD;
&#xD;
          -  Hemodynamic instability (Systolic BP &lt; 75 mmHg or MAP &lt; 60 mmHg despite vasopressors&#xD;
             and/or heart rate &lt; 55 bpm)&#xD;
&#xD;
          -  Attending physician deems the transient application of high airway pressures to be&#xD;
             unsafe&#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>Laurent Brochard, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Unity Health Toronto</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laurent Brochard, MD</last_name>
    <phone>416-864-5686</phone>
    <phone_ext>5686</phone_ext>
    <email>Laurent.Brochard@unityhealth.to</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculdade de Medicina da University São Paulo</name>
      <address>
        <city>São Paulo</city>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marcelo Amato, MD</last_name>
      <email>marcelo.amato@fm.usp.br</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>St. Michael's Hospital</name>
      <address>
        <city>Toronto</city>
        <state>Ontario</state>
        <zip>M5B1T8</zip>
        <country>Canada</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Laurent Brochard, MD</last_name>
      <phone>416-864-6060</phone>
      <phone_ext>5686</phone_ext>
      <email>Laurent.Brochard@unityhealth.to</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milan</city>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Tommaso Mauri, MD</last_name>
      <email>tommaso.mauri@unimi.it</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>Vall d'Hebron University Hospital</name>
      <address>
        <city>Barcelona</city>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Oriol Roca, MD</last_name>
      <email>oroca@vhebron.net</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
    <country>Canada</country>
    <country>Italy</country>
    <country>Spain</country>
  </location_countries>
  <link>
    <url>https://www.plugwgroup.org</url>
    <description>Website of the PLUG working group</description>
  </link>
  <reference>
    <citation>Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, Sklar MC, Rauseo M, Ferguson ND, Fan E, Richard JM, Brochard L. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178-187. doi: 10.1164/rccm.201902-0334OC.</citation>
    <PMID>31577153</PMID>
  </reference>
  <reference>
    <citation>Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.</citation>
    <PMID>19255741</PMID>
  </reference>
  <reference>
    <citation>Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.</citation>
    <PMID>27596161</PMID>
  </reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 3, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 8, 2020</study_first_posted>
  <last_update_submitted>September 29, 2021</last_update_submitted>
  <last_update_submitted_qc>September 29, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 30, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Mechanical Ventilation</keyword>
  <keyword>Lung recruitment</keyword>
  <keyword>ARDS</keyword>
  <keyword>Electrical impedance tomography</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>
  </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/NCT04460859
org study id: 2027
nct id: NCT04460859
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The RECRUIT study is a multinational, multicenter physiological observational study conducted
      by the PLUG working group. It is a single-day study (1.5-2 hours) associated with specific
      lung (de)recruitment maneuvers to verify the feasibility of measuring the potential for lung
      recruitment in mechanically ventilated patients with ARDS by electrical impedance tomography
      (EIT).
Despite higher positive end-expiratory pressure (PEEP) being associated with multiple
      physiologic benefits, randomized clinical trials comparing higher vs. lower PEEP levels
      failed to show improved survival of ARDS patients. Higher PEEP should fully exploit its
      benefits only when implemented in patients with higher potential for alveolar recruitment
      (i.e., the decrease of non-aerated lung tissue at higher airway pressure) or in patients with
      airway closure. Retrospective analysis of randomised clinical trials with PEEP suggests that
      when high PEEP is used in responders (oxygenation), survival may be better. Conversely, in
      the absence of significant recruitment, higher PEEP should be avoided and lower PEEP might be
      recommended.

      Titration of PEEP provided by the mechanical ventilator in patients with severe lung injury
      should thus be based on bedside information on lung recruitability. However, no valid method
      exists to define the best PEEP to optimize recruitment and minimize lung overdistention.
      Recruitability varies and is often not assessed. Electrical impedance tomography (EIT) is a
      non-invasive bedside imaging technique for measuring the potential for lung recruitment in
      ARDS patients. By performing lung (de)recruitment maneuvers and in-depth analyses, we will
      define lung recruitability indices and develop methods for real-time and personalized PEEP
      selection. This study will prove the feasibility of minimizing risks associated with
      inadequate mechanical ventilation by EIT.
observational model: Other
time perspective: Prospective
measure: Potential for lung recruitment
time frame: 2 hours
description: The potential for lung recruitment will be assessed with EIT. Several methods will be used and compared, based on e.g. pixel information of lung aeration, and pressure-volume characteristics at different PEEP steps.
measure: Recruitment-to-inflation (R/I) ratio
time frame: 2 hours
measure: EIT-based optimum PEEP level
time frame: 2 hours
measure: PEEP level resulting in end-expiratory transpulmonary pressure between 0 and 2 cmH2O
time frame: 2 hours
description: For those patients with esophageal pressure measurements available
measure: Organ dysfunction as per the sequential organ failure assessment (SOFA) score
time frame: Day 1, 3, 7
description: SOFA score min-max: 0-24; a higher score is associated with poor prognosis.
measure: Vital status at ICU discharge, 28 days, and hospital discharge
time frame: Through study completion, up to 1 year
description: Vital status (death/alive) will be assessed via chart review
measure: Ventilator free days
time frame: Day 28
arm group label: Intubated mechanically ventilated ARDS patients
description: Intubated mechanically ventilated patients with moderate to severe ARDS according to the Berlin definition
intervention type: Other
intervention name: Specific lung recruitment maneuvers
description: Specific lung recruitment maneuvers will be performed to measure the potential for lung recruitment at different levels of positive end-expiratory pressure (PEEP) provided by the mechanical ventilator. Electrical impedance tomography signals, synchronized signals of airway pressure and flow, esophageal pressure (if available), and volumetric capnography (if available) will be recorded continuously, during the time span of the protocol for offline analysis.
arm group label: Intubated mechanically ventilated ARDS patients
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Laurent Brochard, MD
role: Principal Investigator
affiliation: Unity Health Toronto
last name: Laurent Brochard, MD
phone: 416-864-5686
phone ext: 5686
email: Laurent.Brochard@unityhealth.to
facility: 
status: Recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
country: Brazil
country: Canada
country: Italy
country: Spain
url: https://www.plugwgroup.org
description: Website of the PLUG working group
citation: Chen L, Del Sorbo L, Grieco DL, Junhasavasdikul D, Rittayamai N, Soliman I, Sklar MC, Rauseo M, Ferguson ND, Fan E, Richard JM, Brochard L. Potential for Lung Recruitment Estimated by the Recruitment-to-Inflation Ratio in Acute Respiratory Distress Syndrome. A Clinical Trial. Am J Respir Crit Care Med. 2020 Jan 15;201(2):178-187. doi: 10.1164/rccm.201902-0334OC.
PMID: 31577153
citation: Costa EL, Borges JB, Melo A, Suarez-Sipmann F, Toufen C Jr, Bohm SH, Amato MB. Bedside estimation of recruitable alveolar collapse and hyperdistension by electrical impedance tomography. Intensive Care Med. 2009 Jun;35(6):1132-7. doi: 10.1007/s00134-009-1447-y. Epub 2009 Mar 3.
PMID: 19255741
citation: Frerichs I, Amato MB, van Kaam AH, Tingay DG, Zhao Z, Grychtol B, Bodenstein M, Gagnon H, Bohm SH, Teschner E, Stenqvist O, Mauri T, Torsani V, Camporota L, Schibler A, Wolf GK, Gommers D, Leonhardt S, Adler A; TREND study group. Chest electrical impedance tomography examination, data analysis, terminology, clinical use and recommendations: consensus statement of the TRanslational EIT developmeNt stuDy group. Thorax. 2017 Jan;72(1):83-93. doi: 10.1136/thoraxjnl-2016-208357. Epub 2016 Sep 5.
PMID: 27596161
responsible party type: Sponsor
mesh term: Respiratory Distress Syndrome
mesh term: Respiratory Distress Syndrome, Newborn
mesh term: Acute Lung Injury
sharing ipd: Undecided