<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/NCT04424082</url>
  </required_header>
  <id_info>
    <org_study_id>Karolinska</org_study_id>
    <nct_id>NCT04424082</nct_id>
  </id_info>
  <brief_title>External Dead Space in Ventilated COVID-19 Patients</brief_title>
  <official_title>Influence of External Dead Space on Volumetric Capnography Derived Parameters in Mechanically Ventilated COVID-19 Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karolinska Institutet</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Region Stockholm</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karolinska Institutet</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective is to investigate the efficacy of volumetric capnography to detect changes in&#xD;
      dead space, CO2 elimination and shape factor parameters before and after disconnection of&#xD;
      external dead space in ventilated COVID-19 patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Covid-19 patients under mechanical ventilation are currently managed with a lung protective&#xD;
      strategy derived from ARDSnet recommendations. In order to minimize the risk of spread of&#xD;
      coronavirus, filters and associated respiratory tubing are incorporated to the breathing&#xD;
      circuit, thus increasing apparatus dead space with subsequent increase in dead space&#xD;
      ventilation. Considering the already often compromised ability for these patients to&#xD;
      adequately clear carbon dioxide (VCO2), adding an external dead space can potentially have a&#xD;
      substantial impact on CO2 homeostasis. The study will use volumetric capnography (Vcap) to&#xD;
      investigate the influence of external dead space on VCO2 and calculated alveolar dead space.&#xD;
&#xD;
      Objective: 1) To investigate the efficacy of Vcap to detect changes in dead space, VCO2 and&#xD;
      shape factor parameters before and after disconnection of external dead space.&#xD;
&#xD;
      2) To register the external dead space impact on arterial carbon dioxide tension (PaCO2).&#xD;
&#xD;
      3) To calculate the alveolar dead space based on Vcap data and arterial blood gas analysis&#xD;
      results.&#xD;
&#xD;
      Design and setting: Prospective observational study in an intensive care center for Covid-19&#xD;
      patients in a university hospital.&#xD;
&#xD;
      Patients: Covid-19 positive patients of all age groups under mechanical ventilation.&#xD;
      Exclusion criteria is ongoing ECMO treatment&#xD;
&#xD;
      Measurements and results: Vcap and Tcap parameters will be registered during mechanical&#xD;
      ventilation and correlated to an arterial blood gas sample. Part of the apparatus dead space&#xD;
      will then be reduced via removal of the heat and moister exchange filter (HME) with added&#xD;
      tubing resulting in a reduction in volume of approximately 80 ml (i.e. the known volume of&#xD;
      the HME filter and associated tubing). After the apparatus dead space is removed, the Vcap&#xD;
      will be recorded for approximately 15 minutes and an arterial blood gas will be drawn at the&#xD;
      end of the period. The HME and associated tubing will then be reattached to the breathing&#xD;
      circuit and Vcap and Tcap parameters will be recorded for approximately 30 minutes and an&#xD;
      arterial blood gas will be drawn. Vcap data will be analyzed for dead space, slope of phase&#xD;
      III, VCO2 and associated shape factor parameters and compared with Tcap parameters. Changes&#xD;
      in Vcap parameters will be tested for statistical significance using one and two-way ANOVA&#xD;
      for repeated measures and Bland-Altman analysis will be used for comparison.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 9, 2020</start_date>
  <completion_date type="Actual">May 27, 2021</completion_date>
  <primary_completion_date type="Actual">June 25, 2020</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>change in carbon dioxide elimination (VCO2) i.e. ml CO2 eliminated/minute</measure>
    <time_frame>60 minutes</time_frame>
    <description>VCO2 is expected to increase after removal of the external dead space</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes in alveolar dead space (a Vcap derived parameter)</measure>
    <time_frame>60 minutes</time_frame>
    <description>Removing the external dead space is expected to decrease alveolar dead space (ml)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes in arterial carbon dioxide tension (PaCO2).</measure>
    <time_frame>60 minutes</time_frame>
    <description>Removal of external dead space is expected to decrease PaCO2 (kPa).</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Coronavirus</condition>
  <condition>ARDS, Human</condition>
  <arm_group>
    <arm_group_label>dead space removal</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>external dead space will be removed and Vcap parameters (VCO2, PaCO2 and alveolar dead space) recorded before and after.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Removal of dead space filter</intervention_name>
    <description>Dead space filters will be removed and Vcap parameters (VCO2 ml/min, PaCO2 kPa, alveolar dead space in ml) recorded before and after removal</description>
    <arm_group_label>dead space removal</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Covid-19 positive patients of all age groups under mechanical ventilation&#xD;
&#xD;
        -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Exclusion criteria is ongoing ECMO treatment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Björn Persson, MD PhD</last_name>
    <role>Study Director</role>
    <affiliation>Karolinska University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Karolinska University Hospital</name>
      <address>
        <city>Stockholm</city>
        <zip>171 76</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>June 7, 2020</study_first_submitted>
  <study_first_submitted_qc>June 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>May 27, 2021</last_update_submitted>
  <last_update_submitted_qc>May 27, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Karolinska Institutet</investigator_affiliation>
    <investigator_full_name>Jacob Karlsson</investigator_full_name>
    <investigator_title>MD PhD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Distress Syndrome</mesh_term>
  </condition_browse>
  <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/NCT04424082
org study id: Karolinska
nct id: NCT04424082
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The objective is to investigate the efficacy of volumetric capnography to detect changes in
      dead space, CO2 elimination and shape factor parameters before and after disconnection of
      external dead space in ventilated COVID-19 patients.
Covid-19 patients under mechanical ventilation are currently managed with a lung protective
      strategy derived from ARDSnet recommendations. In order to minimize the risk of spread of
      coronavirus, filters and associated respiratory tubing are incorporated to the breathing
      circuit, thus increasing apparatus dead space with subsequent increase in dead space
      ventilation. Considering the already often compromised ability for these patients to
      adequately clear carbon dioxide (VCO2), adding an external dead space can potentially have a
      substantial impact on CO2 homeostasis. The study will use volumetric capnography (Vcap) to
      investigate the influence of external dead space on VCO2 and calculated alveolar dead space.

      Objective: 1) To investigate the efficacy of Vcap to detect changes in dead space, VCO2 and
      shape factor parameters before and after disconnection of external dead space.

      2) To register the external dead space impact on arterial carbon dioxide tension (PaCO2).

      3) To calculate the alveolar dead space based on Vcap data and arterial blood gas analysis
      results.

      Design and setting: Prospective observational study in an intensive care center for Covid-19
      patients in a university hospital.

      Patients: Covid-19 positive patients of all age groups under mechanical ventilation.
      Exclusion criteria is ongoing ECMO treatment

      Measurements and results: Vcap and Tcap parameters will be registered during mechanical
      ventilation and correlated to an arterial blood gas sample. Part of the apparatus dead space
      will then be reduced via removal of the heat and moister exchange filter (HME) with added
      tubing resulting in a reduction in volume of approximately 80 ml (i.e. the known volume of
      the HME filter and associated tubing). After the apparatus dead space is removed, the Vcap
      will be recorded for approximately 15 minutes and an arterial blood gas will be drawn at the
      end of the period. The HME and associated tubing will then be reattached to the breathing
      circuit and Vcap and Tcap parameters will be recorded for approximately 30 minutes and an
      arterial blood gas will be drawn. Vcap data will be analyzed for dead space, slope of phase
      III, VCO2 and associated shape factor parameters and compared with Tcap parameters. Changes
      in Vcap parameters will be tested for statistical significance using one and two-way ANOVA
      for repeated measures and Bland-Altman analysis will be used for comparison.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: change in carbon dioxide elimination (VCO2) i.e. ml CO2 eliminated/minute
time frame: 60 minutes
description: VCO2 is expected to increase after removal of the external dead space
measure: Changes in alveolar dead space (a Vcap derived parameter)
time frame: 60 minutes
description: Removing the external dead space is expected to decrease alveolar dead space (ml)
measure: Changes in arterial carbon dioxide tension (PaCO2).
time frame: 60 minutes
description: Removal of external dead space is expected to decrease PaCO2 (kPa).
arm group label: dead space removal
arm group type: Other
description: external dead space will be removed and Vcap parameters (VCO2, PaCO2 and alveolar dead space) recorded before and after.
intervention type: Other
intervention name: Removal of dead space filter
description: Dead space filters will be removed and Vcap parameters (VCO2 ml/min, PaCO2 kPa, alveolar dead space in ml) recorded before and after removal
arm group label: dead space removal
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Björn Persson, MD PhD
role: Study Director
affiliation: Karolinska University
facility: 
country: Sweden
responsible party type: Principal Investigator
investigator affiliation: Karolinska Institutet
investigator full name: Jacob Karlsson
investigator title: MD PhD
mesh term: Respiratory Distress Syndrome
sharing ipd: No