<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/NCT03006692</url>
  </required_header>
  <id_info>
    <org_study_id>ABL Laegebil Odense</org_study_id>
    <nct_id>NCT03006692</nct_id>
  </id_info>
  <brief_title>Diagnostic Value of Arterial Blood Gas Analysis in Prehospital Patients</brief_title>
  <acronym>ABL</acronym>
  <official_title>Diagnostic Value of Arterial Blood Gas Analysis in Prehospital Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Odense University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Odense University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In the anesthesiologist-manned mobile emergency car unit an analyzing device for blood gas&#xD;
      testing is present since 2014. This study will determine if a prehospital arterial blood gas&#xD;
      helps the doctor to make more precise diagnosis prehospitally. Furthermore it will be&#xD;
      determined if the doctors find this device helpful in assessing and treating patients with&#xD;
      affected consciousness.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 2016</start_date>
  <completion_date type="Actual">April 1, 2018</completion_date>
  <primary_completion_date type="Actual">April 2018</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Diagnostic accuracy</measure>
    <time_frame>220 patients in 1.5 year</time_frame>
    <description>Will there be fewer observational diagnosis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Doctor satisfaction</measure>
    <time_frame>220 patients in 1.5 year</time_frame>
    <description>Did the doctor find the arterial gas or lack of it affected the treatment and diagnosis</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">300</enrollment>
  <condition>Unconscious (Psychology)</condition>
  <arm_group>
    <arm_group_label>Take arterial blood gas</arm_group_label>
    <description>Patients with impaired consciousness are randomised into having analysed a arterial blood gas.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Do not take arterial blood gas</arm_group_label>
    <description>Patients with impaired consciousness are randomised into not having analysed a arterial blood gas.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>With arterial blood gas, parameters not being normal can be corrected</intervention_name>
    <description>If arterial blood gas is analysed answers provide the possibility to make more accurate diagnosis and treat specific abnormal parameters (e.g. electrolytes, oxygenation and so forth).</description>
    <arm_group_label>Take arterial blood gas</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        220 patients seen prehospital by the mobile emergency care unit in Odense, Denmark.&#xD;
        Patients have to have impaired consciousness (Glasgow Coma Scale &lt; 13).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  GCS &lt; 13&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breastfeeding&#xD;
&#xD;
          -  detained or imprisoned patient&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense C</city>
        <state>Odense</state>
        <zip>DK-5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2018</verification_date>
  <study_first_submitted>December 27, 2016</study_first_submitted>
  <study_first_submitted_qc>December 27, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 30, 2016</study_first_posted>
  <last_update_submitted>May 3, 2018</last_update_submitted>
  <last_update_submitted_qc>May 3, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 4, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Stine Zwisler</investigator_full_name>
    <investigator_title>Anesthesiologist, ph.d.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Unconsciousness</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/NCT03006692
org study id: ABL Laegebil Odense
nct id: NCT03006692
lead sponsor: 
has dmc: No
In the anesthesiologist-manned mobile emergency car unit an analyzing device for blood gas
      testing is present since 2014. This study will determine if a prehospital arterial blood gas
      helps the doctor to make more precise diagnosis prehospitally. Furthermore it will be
      determined if the doctors find this device helpful in assessing and treating patients with
      affected consciousness.
observational model: Case-Control
time perspective: Prospective
measure: Diagnostic accuracy
time frame: 220 patients in 1.5 year
description: Will there be fewer observational diagnosis
measure: Doctor satisfaction
time frame: 220 patients in 1.5 year
description: Did the doctor find the arterial gas or lack of it affected the treatment and diagnosis
arm group label: Take arterial blood gas
description: Patients with impaired consciousness are randomised into having analysed a arterial blood gas.
arm group label: Do not take arterial blood gas
description: Patients with impaired consciousness are randomised into not having analysed a arterial blood gas.
intervention type: Other
intervention name: With arterial blood gas, parameters not being normal can be corrected
description: If arterial blood gas is analysed answers provide the possibility to make more accurate diagnosis and treat specific abnormal parameters (e.g. electrolytes, oxygenation and so forth).
arm group label: Take arterial blood gas
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Stine Zwisler
investigator title: Anesthesiologist, ph.d.
mesh term: Unconsciousness