<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/NCT01686984</url>
  </required_header>
  <id_info>
    <org_study_id>2012/381</org_study_id>
    <nct_id>NCT01686984</nct_id>
  </id_info>
  <brief_title>Influence of Inspiratory Flow Pattern on Exchange of Carbon Dioxide in Humans Without Primary Lung Disease</brief_title>
  <official_title>Influence of Inspiratory Flow Pattern on Exchange of Carbon Dioxide in Humans Without Primary Lung Disease</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 of this study is to investigate how inspiratory flow pattern influences CO2&#xD;
      elimination in people without primary lung disease.&#xD;
&#xD;
      The hypothesis is that a long mean distribution time, caused by a long postinspiratory pause&#xD;
      and high end-inspiratory flow, will promote CO2 exchange in the alveoli.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 2015</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>Carbon dioxide elimination in a ventilator assisted breath.</measure>
    <time_frame>30 minutes</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Blood CO2 concentration.</measure>
    <time_frame>30 minutes</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">8</enrollment>
  <condition>Pulmonary Gas Exchange</condition>
  <condition>Carbon Dioxide</condition>
  <arm_group>
    <arm_group_label>Altered breath</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The group where the investigators alter the inspiratory and expiratory aspects of a ventilated breath.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Altered breath</intervention_name>
    <arm_group_label>Altered breath</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  No known primary lung disease&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Primary lung disease&#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>Mikael Bodelsson, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>Division of Anesthesia, Skane University Hospital, Lund, Sweden</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Division of Brain, Heart and Lungs, Neurosurgical Clinic, Skane University Hospital, Lund</name>
      <address>
        <city>Lund</city>
        <state>Skane</state>
        <zip>22185</zip>
        <country>Sweden</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Sweden</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 18, 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>Lung Diseases</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/NCT01686984
org study id: 2012/381
nct id: NCT01686984
lead sponsor: 
has dmc: No
The purpose of this study is to investigate how inspiratory flow pattern influences CO2
      elimination in people without primary lung disease.

      The hypothesis is that a long mean distribution time, caused by a long postinspiratory pause
      and high end-inspiratory flow, will promote CO2 exchange in the alveoli.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Carbon dioxide elimination in a ventilator assisted breath.
time frame: 30 minutes
measure: Blood CO2 concentration.
time frame: 30 minutes
arm group label: Altered breath
arm group type: Experimental
description: The group where the investigators alter the inspiratory and expiratory aspects of a ventilated breath.
intervention type: Other
intervention name: Altered breath
arm group label: Altered breath
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Mikael Bodelsson, Professor
role: Principal Investigator
affiliation: Division of Anesthesia, Skane University Hospital, Lund, Sweden
facility: 
country: Sweden
responsible party type: Sponsor
mesh term: Lung Diseases