<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/NCT01699802</url>
  </required_header>
  <id_info>
    <org_study_id>2012/148</org_study_id>
    <nct_id>NCT01699802</nct_id>
  </id_info>
  <brief_title>Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa)</brief_title>
  <official_title>Influence of Inhaled Anaesthetics on Rebreathing of Carbon Dioxide When Using an Anaesthesia Gas Reflector (AnaConDa)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Region Skane</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Region Skane</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose is to investigate how the adsorptive capacity of the active carbon filter to&#xD;
      carbon dioxide in an anaesthetic gas reflector (AnaConDa) is affected by adding inhaled&#xD;
      anaesthetic agent.&#xD;
&#xD;
      The hypothesis is that addition of inhaled anaesthetic agent will affect the amount of&#xD;
      adsorption of carbon dioxide to the active carbon and thereby affect rebreathing of carbon&#xD;
      dioxide.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">December 2014</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>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Volume of carbon dioxide rebreathing from an anesthetic gas reflector</measure>
    <time_frame>2 hours</time_frame>
    <description>Tidal carbon dioxide volume rebreathed from an anesthetic gas reflector correlated to concentration of delivered anesthetic gas.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Quantification of ventilatory requirements to maintain isocapnia with the use of an anesthetic gas reflector.</measure>
    <time_frame>2 hours</time_frame>
    <description>Changes of tidal volume required to maintain constant alveolar ventilation will be assessed by continuous measurement of exhaled tidal carbon dioxide volume, the latter to be maintained at a constant value.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">12</enrollment>
  <condition>Ischemic Heart Disease</condition>
  <arm_group>
    <arm_group_label>Inhaled anaesthetic agent</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group where the investigators adds inhaled anaesthetic agent when using the anaesthetic gas reflector (AnaConda).</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Inhaled anaesthetic agent</intervention_name>
    <arm_group_label>Inhaled anaesthetic agent</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  elective coronary artery by-pass graft surgery&#xD;
&#xD;
          -  elective valve replacement surgery&#xD;
&#xD;
          -  normal left ventricular ejection fraction on preoperative echocardiography&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  obstructive lung disease&#xD;
&#xD;
          -  restrictive lung disease&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mikael Bodelsson, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Divison of Surgery, Department of Anaesthesia, Skane University Hospital, Lund, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Skane University Hospital Lund, Cardiothoracic Intensive Care</name>
      <address>
        <city>Lund</city>
        <zip>SE-221 85</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 25, 2012</study_first_submitted>
  <study_first_submitted_qc>October 1, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 4, 2012</study_first_posted>
  <last_update_submitted>May 13, 2015</last_update_submitted>
  <last_update_submitted_qc>May 13, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 14, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart Diseases</mesh_term>
    <mesh_term>Myocardial Ischemia</mesh_term>
    <mesh_term>Coronary Artery Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Anesthetics</mesh_term>
  </intervention_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/NCT01699802
org study id: 2012/148
nct id: NCT01699802
lead sponsor: 
has dmc: No
The purpose is to investigate how the adsorptive capacity of the active carbon filter to
      carbon dioxide in an anaesthetic gas reflector (AnaConDa) is affected by adding inhaled
      anaesthetic agent.

      The hypothesis is that addition of inhaled anaesthetic agent will affect the amount of
      adsorption of carbon dioxide to the active carbon and thereby affect rebreathing of carbon
      dioxide.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Volume of carbon dioxide rebreathing from an anesthetic gas reflector
time frame: 2 hours
description: Tidal carbon dioxide volume rebreathed from an anesthetic gas reflector correlated to concentration of delivered anesthetic gas.
measure: Quantification of ventilatory requirements to maintain isocapnia with the use of an anesthetic gas reflector.
time frame: 2 hours
description: Changes of tidal volume required to maintain constant alveolar ventilation will be assessed by continuous measurement of exhaled tidal carbon dioxide volume, the latter to be maintained at a constant value.
arm group label: Inhaled anaesthetic agent
arm group type: Experimental
description: The group where the investigators adds inhaled anaesthetic agent when using the anaesthetic gas reflector (AnaConda).
intervention type: Other
intervention name: Inhaled anaesthetic agent
arm group label: Inhaled anaesthetic agent
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Mikael Bodelsson, Professor
role: Principal Investigator
affiliation: Divison of Surgery, Department of Anaesthesia, Skane University Hospital, Lund, Sweden
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Heart Diseases
mesh term: Myocardial Ischemia
mesh term: Coronary Artery Disease
mesh term: Anesthetics