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/NCT06024993</url>
    </required_header>
    <id_info>
      <org_study_id>003029</org_study_id>
      <nct_id>NCT06024993</nct_id>
    </id_info>
    <brief_title>Dead Space in Mechanical Ventilation With Constant Expiratory Flow</brief_title>
    <acronym>DeXFLoW</acronym>
    <official_title>Dead Space in Mechanical Ventilation With Constant Expiratory Flow</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University Hospital, Antwerp</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Universiteit Antwerpen</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University Hospital, Antwerp</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        Conventional continuous mandatory mechanical ventilation relies on the passive recoil of the&#xD;
        chest wall for expiration. This results in an exponentially decreasing expiratory flow.&#xD;
  &#xD;
        Flow controlled ventilation (FCV), a new ventilation mode with constant, continuous,&#xD;
        controlled expiratory flow, has recently become clinically available and is increasingly&#xD;
        being adopted for complex mechanical ventilation during surgery.&#xD;
  &#xD;
        In both clinical and pre-clinical settings, an improvement in ventilation (CO2 clearance) has&#xD;
        been observed during FCV compared to conventional ventilation. Recently, Schranc et al.&#xD;
        compared flow-controlled ventilation with pressure-regulated volume control in both double&#xD;
        lung ventilation and one-lung ventilation in pigs. They report differences in dead space&#xD;
        ventilation that may explain the improved CO2 clearance, although their study was not&#xD;
        designed to compare dead space ventilation within the group of double lung ventilation.&#xD;
  &#xD;
        Dead space ventilation, or &quot;wasted ventilation&quot;, is the ventilation of hypoperfused lung&#xD;
        zones, and is clinically relevant, as it is a strong predictor of mortality in patients with&#xD;
        the acute respiratory distress syndrome (ARDS) and is correlated with higher airway driving&#xD;
        pressures which are thought to be injurious to the lung (lung stress).&#xD;
  &#xD;
        This trial aims to study the difference in dead space ventilation between conventional&#xD;
        mechanical ventilation in volume-controlled mode and flow controlled-ventilation.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">December 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">July 1, 2024</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>Crossover Assignment</intervention_model>
      <intervention_model_description>Crossover volume-controlled ventilation and flow-controlled ventilation</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>During analysis the groups (flow-controlled ventilation and volume-controlled ventilation) will be blinded.&#xD;
  Participants know that they will be exposed to both modes of ventilation, but are unaware of the randomized sequence (FCV-VCV or VCV-FCV).&#xD;
  It is impossible to mask the investigators delivering the intervention.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in Bohr dead space ventilation (VDBr/VT)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>Quantified by the Bohr approach with volumetric capnography</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in Enghoff dead space ventilation (VDEng/VT)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>Quantified by the Enghoff approach with volumetric capnography</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in physiological dead space volume (Vdfys)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>Measured with volumetric capnography and Enghoff's approach</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in airway dead space volume (Vdaw)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>Measured with volumetric capnography and Fletcher's approach</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in alveolar dead space volume (Vdalv)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>As measured with volumetric capnography and Fletcher's approach</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Ventilatory efficiency (VE/VCO2)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>Ratio of minute ventilation to carbon dioxide output</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in airway driving pressure (∆Paw)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>Calculated as the difference between the plateau pressure (Pplat) during an inspiratory pause and the dynamic positive end-expiratory pressure (PEEP), as no expiratory hold is possible on the Evone.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in transpulmonary shunt fraction (Qs/Qt)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>calculated with the modified Berggren equation</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in global lung hyperdistention (hyperdistentionEIT)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>Calculated from electric impedance tomography</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in anterio-posterior distribution of ventilation on EIT (AP)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>% anterior / % posterior</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in right-left distribution of ventilation on EIT (RL)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>% right / % left</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in 4-layered distribution of ventilation on EIT</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in centre of ventilation on EIT</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in cardiac index (CI)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>Calculated from the arterial waveform (pulse contour analysis) by the HemoSphere monitor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in mean arterial pressure (MAP)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>Measured on a radial artery line</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in partial pressure of arterial CO2 (PaCO2)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>Measured on an arterial blood gas</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in peak expiratory flow (PEF)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>As measured by the citrex respiratory monitor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in peak inspiratory flow (PIF)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>As measured by the citrex respiratory monitor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in mean airway pressure (MPaw)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>As measured by the citrex respiratory monitor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in tidal volume (TV)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>As measured by the citrex respiratory monitor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in respiratory rate (RR)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>As measured by the citrex respiratory monitor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in minute ventilation (MV)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>As measured by the citrex respiratory monitor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in inspiratory time (Ti)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>As measured by the citrex respiratory monitor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in expiratory time (Te)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>As measured by the citrex respiratory monitor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in ratio of inspiratory time to total breath time (Ti / Tt)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>As measured by the citrex respiratory monitor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in positive end-expiratory pressure (PEEP)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>As measured by the citrex respiratory monitor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in peak inspiratory pressure (PIP)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>As measured by the citrex respiratory monitor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in plateau pressure (Pplat)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>As measured by the citrex respiratory monitor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in static airway compliance (Caw)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>Calculated as tidal volume / airway driving pressure</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in end-tidal CO2 (ETCO2)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>As measured by the citrex respiratory monitor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in global airway resistance (Raw)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>As measured by the citrex respiratory monitor</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in global airway time constant (TAUaw)</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>Calculated as global airway resistance x global airway compliance</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in total energy</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>As calculated from monitoring data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in dissipated energy</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>As calculated from monitoring data</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in P/F ratio</measure>
      <time_frame>During FCV and VCV measurements (30 minutes)</time_frame>
      <description>Calculated as partial pressure of arterial oxygen divided by inspiratory fraction of oxygen</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">13</enrollment>
    <condition>Mechanical Ventilation</condition>
    <condition>Artificial Respiration</condition>
    <arm_group>
      <arm_group_label>FCV-VCV</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After titration of ventilation in baseline VCV (all arms), participants will first receive 30 min of baseline-matched FCV and subsequently 30 min of baseline-matched VCV.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>VCV-FCV</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After titration of ventilation in baseline VCV (all arms), participants will first receive 30 min of baseline-matched VCV and subsequently 30 min of baseline-matched FCV.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Flow-controlled ventilation (FCV)</intervention_name>
      <description>30 minutes of FCV, delivered with the CE-marked Evone ventilator (Ventinova medical, the Netherlands)</description>
      <arm_group_label>FCV-VCV</arm_group_label>
      <arm_group_label>VCV-FCV</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Conventional volume-controlled ventilation (VCV)</intervention_name>
      <description>30 minutes of conventional VCV, delivered with the CE-marked Aisys CS3 (GE Healthcare, USA) or Flow-i (Getinge, Sweden) ventilators.</description>
      <arm_group_label>FCV-VCV</arm_group_label>
      <arm_group_label>VCV-FCV</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults [18-70] yrs&#xD;
  &#xD;
            -  General anaesthesia for elective surgery&#xD;
  &#xD;
            -  Arterial line, central venous line and endotracheal tube as part of standard of care&#xD;
  &#xD;
            -  Expected duration of controlled mechanical ventilation ≥ 60 minutes&#xD;
  &#xD;
            -  Supine position (0±10°)&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  One lung ventilation&#xD;
  &#xD;
            -  Known pregnancy&#xD;
  &#xD;
            -  Increased abdominal pressure (laparoscopy or BMI &gt; 30kg/m2)&#xD;
  &#xD;
            -  COPD GOLD IV or home oxygen dependence&#xD;
  &#xD;
            -  Clinical signs of raised intracranial pressure&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>70 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Vera Saldien, M.D., Ph.D.</last_name>
      <role>Principal Investigator</role>
      <affiliation>Antwerp University Hospital / University of Antwerp</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Carine Smitz</last_name>
      <phone>+32 3 821 49 30</phone>
      <email>carine.smitz@uza.be</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Joke De Wachter</last_name>
      <phone>+32 3 821 30 42</phone>
      <email>joke.dewachter@uza.be</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Antwerp University Hospital (UZA)</name>
        <address>
          <city>Edegem</city>
          <state>Antwerp</state>
          <zip>2650</zip>
          <country>Belgium</country>
        </address>
      </facility>
      <contact>
        <last_name>Carine Smitz</last_name>
        <phone>+323 821 49 30</phone>
        <email>carine.smitz@uza.be</email>
      </contact>
      <investigator>
        <last_name>Tom Schepens, M.D., Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Philippe G Jorens, M.D., Ph.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Gregory R De Meyer, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Vincent Vandebergh, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Stuart G Morrison, M.D.</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Vera Saldien, M.D., Ph.D.</last_name>
        <role>Principal Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>Belgium</country>
    </location_countries>
    <verification_date>March 2023</verification_date>
    <study_first_submitted>April 3, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 6, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 6, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <!-- 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/NCT06024993
  org study id: 003029
  nct id: NCT06024993
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  Conventional continuous mandatory mechanical ventilation relies on the passive recoil of the
        chest wall for expiration. This results in an exponentially decreasing expiratory flow.
  
        Flow controlled ventilation (FCV), a new ventilation mode with constant, continuous,
        controlled expiratory flow, has recently become clinically available and is increasingly
        being adopted for complex mechanical ventilation during surgery.
  
        In both clinical and pre-clinical settings, an improvement in ventilation (CO2 clearance) has
        been observed during FCV compared to conventional ventilation. Recently, Schranc et al.
        compared flow-controlled ventilation with pressure-regulated volume control in both double
        lung ventilation and one-lung ventilation in pigs. They report differences in dead space
        ventilation that may explain the improved CO2 clearance, although their study was not
        designed to compare dead space ventilation within the group of double lung ventilation.
  
        Dead space ventilation, or "wasted ventilation", is the ventilation of hypoperfused lung
        zones, and is clinically relevant, as it is a strong predictor of mortality in patients with
        the acute respiratory distress syndrome (ARDS) and is correlated with higher airway driving
        pressures which are thought to be injurious to the lung (lung stress).
  
        This trial aims to study the difference in dead space ventilation between conventional
        mechanical ventilation in volume-controlled mode and flow controlled-ventilation.
  allocation: Randomized
  intervention model: Crossover Assignment
  intervention model description: Crossover volume-controlled ventilation and flow-controlled ventilation
  primary purpose: Basic Science
  masking: Double (Participant, Outcomes Assessor)
  masking description: During analysis the groups (flow-controlled ventilation and volume-controlled ventilation) will be blinded.
  Participants know that they will be exposed to both modes of ventilation, but are unaware of the randomized sequence (FCV-VCV or VCV-FCV).
  It is impossible to mask the investigators delivering the intervention.
  measure: Change in Bohr dead space ventilation (VDBr/VT)
  time frame: During FCV and VCV measurements (30 minutes)
  description: Quantified by the Bohr approach with volumetric capnography
  measure: Change in Enghoff dead space ventilation (VDEng/VT)
  time frame: During FCV and VCV measurements (30 minutes)
  description: Quantified by the Enghoff approach with volumetric capnography
  measure: Change in physiological dead space volume (Vdfys)
  time frame: During FCV and VCV measurements (30 minutes)
  description: Measured with volumetric capnography and Enghoff's approach
  measure: Change in airway dead space volume (Vdaw)
  time frame: During FCV and VCV measurements (30 minutes)
  description: Measured with volumetric capnography and Fletcher's approach
  measure: Change in alveolar dead space volume (Vdalv)
  time frame: During FCV and VCV measurements (30 minutes)
  description: As measured with volumetric capnography and Fletcher's approach
  measure: Ventilatory efficiency (VE/VCO2)
  time frame: During FCV and VCV measurements (30 minutes)
  description: Ratio of minute ventilation to carbon dioxide output
  measure: Change in airway driving pressure (∆Paw)
  time frame: During FCV and VCV measurements (30 minutes)
  description: Calculated as the difference between the plateau pressure (Pplat) during an inspiratory pause and the dynamic positive end-expiratory pressure (PEEP), as no expiratory hold is possible on the Evone.
  measure: Change in transpulmonary shunt fraction (Qs/Qt)
  time frame: During FCV and VCV measurements (30 minutes)
  description: calculated with the modified Berggren equation
  measure: Change in global lung hyperdistention (hyperdistentionEIT)
  time frame: During FCV and VCV measurements (30 minutes)
  description: Calculated from electric impedance tomography
  measure: Change in anterio-posterior distribution of ventilation on EIT (AP)
  time frame: During FCV and VCV measurements (30 minutes)
  description: % anterior / % posterior
  measure: Change in right-left distribution of ventilation on EIT (RL)
  time frame: During FCV and VCV measurements (30 minutes)
  description: % right / % left
  measure: Change in 4-layered distribution of ventilation on EIT
  time frame: During FCV and VCV measurements (30 minutes)
  measure: Change in centre of ventilation on EIT
  time frame: During FCV and VCV measurements (30 minutes)
  measure: Change in cardiac index (CI)
  time frame: During FCV and VCV measurements (30 minutes)
  description: Calculated from the arterial waveform (pulse contour analysis) by the HemoSphere monitor
  measure: Change in mean arterial pressure (MAP)
  time frame: During FCV and VCV measurements (30 minutes)
  description: Measured on a radial artery line
  measure: Change in partial pressure of arterial CO2 (PaCO2)
  time frame: During FCV and VCV measurements (30 minutes)
  description: Measured on an arterial blood gas
  measure: Change in peak expiratory flow (PEF)
  time frame: During FCV and VCV measurements (30 minutes)
  description: As measured by the citrex respiratory monitor
  measure: Change in peak inspiratory flow (PIF)
  time frame: During FCV and VCV measurements (30 minutes)
  description: As measured by the citrex respiratory monitor
  measure: Change in mean airway pressure (MPaw)
  time frame: During FCV and VCV measurements (30 minutes)
  description: As measured by the citrex respiratory monitor
  measure: Change in tidal volume (TV)
  time frame: During FCV and VCV measurements (30 minutes)
  description: As measured by the citrex respiratory monitor
  measure: Change in respiratory rate (RR)
  time frame: During FCV and VCV measurements (30 minutes)
  description: As measured by the citrex respiratory monitor
  measure: Change in minute ventilation (MV)
  time frame: During FCV and VCV measurements (30 minutes)
  description: As measured by the citrex respiratory monitor
  measure: Change in inspiratory time (Ti)
  time frame: During FCV and VCV measurements (30 minutes)
  description: As measured by the citrex respiratory monitor
  measure: Change in expiratory time (Te)
  time frame: During FCV and VCV measurements (30 minutes)
  description: As measured by the citrex respiratory monitor
  measure: Change in ratio of inspiratory time to total breath time (Ti / Tt)
  time frame: During FCV and VCV measurements (30 minutes)
  description: As measured by the citrex respiratory monitor
  measure: Change in positive end-expiratory pressure (PEEP)
  time frame: During FCV and VCV measurements (30 minutes)
  description: As measured by the citrex respiratory monitor
  measure: Change in peak inspiratory pressure (PIP)
  time frame: During FCV and VCV measurements (30 minutes)
  description: As measured by the citrex respiratory monitor
  measure: Change in plateau pressure (Pplat)
  time frame: During FCV and VCV measurements (30 minutes)
  description: As measured by the citrex respiratory monitor
  measure: Change in static airway compliance (Caw)
  time frame: During FCV and VCV measurements (30 minutes)
  description: Calculated as tidal volume / airway driving pressure
  measure: Change in end-tidal CO2 (ETCO2)
  time frame: During FCV and VCV measurements (30 minutes)
  description: As measured by the citrex respiratory monitor
  measure: Change in global airway resistance (Raw)
  time frame: During FCV and VCV measurements (30 minutes)
  description: As measured by the citrex respiratory monitor
  measure: Change in global airway time constant (TAUaw)
  time frame: During FCV and VCV measurements (30 minutes)
  description: Calculated as global airway resistance x global airway compliance
  measure: Change in total energy
  time frame: During FCV and VCV measurements (30 minutes)
  description: As calculated from monitoring data
  measure: Change in dissipated energy
  time frame: During FCV and VCV measurements (30 minutes)
  description: As calculated from monitoring data
  measure: Change in P/F ratio
  time frame: During FCV and VCV measurements (30 minutes)
  description: Calculated as partial pressure of arterial oxygen divided by inspiratory fraction of oxygen
  arm group label: FCV-VCV
  arm group type: Experimental
  description: After titration of ventilation in baseline VCV (all arms), participants will first receive 30 min of baseline-matched FCV and subsequently 30 min of baseline-matched VCV.
  arm group label: VCV-FCV
  arm group type: Experimental
  description: After titration of ventilation in baseline VCV (all arms), participants will first receive 30 min of baseline-matched VCV and subsequently 30 min of baseline-matched FCV.
  intervention type: Device
  intervention name: Flow-controlled ventilation (FCV)
  description: 30 minutes of FCV, delivered with the CE-marked Evone ventilator (Ventinova medical, the Netherlands)
  arm group label: FCV-VCV
  arm group label: VCV-FCV
  intervention type: Device
  intervention name: Conventional volume-controlled ventilation (VCV)
  description: 30 minutes of conventional VCV, delivered with the CE-marked Aisys CS3 (GE Healthcare, USA) or Flow-i (Getinge, Sweden) ventilators.
  arm group label: FCV-VCV
  arm group label: VCV-FCV
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 70 Years
  healthy volunteers: No
  last name: Vera Saldien, M.D., Ph.D.
  role: Principal Investigator
  affiliation: Antwerp University Hospital / University of Antwerp
  last name: Carine Smitz
  phone: +32 3 821 49 30
  email: carine.smitz@uza.be
  last name: Joke De Wachter
  phone: +32 3 821 30 42
  email: joke.dewachter@uza.be
  facility: 
  contact: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: Belgium
  responsible party type: Sponsor