<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/NCT01660724</url>
  </required_header>
  <id_info>
    <org_study_id>Mulvarp2012</org_study_id>
    <nct_id>NCT01660724</nct_id>
  </id_info>
  <brief_title>Ultrasound Guided Arterial Puncture</brief_title>
  <official_title>Ultrasound Guided Arterial Puncture: a Prospective, Blinded, Randomised Controlled Trial.</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>
      The main purpose of the study is to evaluate whether the routine use of ultrasound guided&#xD;
      arterial puncture can increase the proportion of patients who only needs one puncture attempt&#xD;
      in order to successfully extract enough blood to make an arterial blood gas analysis, when&#xD;
      ultrasound guided arterial puncture is compared to conventional arterial puncture technique.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2012</start_date>
  <completion_date type="Actual">August 2013</completion_date>
  <primary_completion_date type="Actual">August 2013</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>Parallel Assignment</intervention_model>
    <masking>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The proportion of patients who only needs one puncture attempt in order to successfully extract enough blood to make an arterial blood gas analysis</measure>
    <time_frame>up to 1 hour after arterial puncture</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Time used for arterial puncture</measure>
    <time_frame>up to 1 hour after arterial puncture</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient corporation</measure>
    <time_frame>up to 1 hour after arterial puncture</time_frame>
    <description>Patient corporation is subjectively estimated by the physician performing the arterial puncture. The degree of patient corporation are assessed on a scale from 1 - 5, where 1 is very poor patient corporation and 5 is perfect patient corporation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain Scores on the Visual Analog Scale</measure>
    <time_frame>Up to 1 hour after arterial puncture</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of attempts before successfully acquiring arterial puncture</measure>
    <time_frame>up to 1 hour after arterial puncture</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">238</enrollment>
  <condition>Arterial Puncture</condition>
  <arm_group>
    <arm_group_label>Ultrasound guided arterial puncture</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients randomised to the this arm has arterial puncture performed using simultaneously ultrasound in order to guide the passage of the syringe from the patient's skin to the artery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional arterial puncture technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomised to the active comparator arm has arterial puncture performed using the conventional technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound guided arterial puncture</intervention_name>
    <description>Arterial puncture is performed using simultaneously ultrasound in order to guide the passage of the syringe from the patient's skin to the artery</description>
    <arm_group_label>Ultrasound guided arterial puncture</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Conventional arterial puncture technique</intervention_name>
    <description>Arterial puncture is performed using the conventional technique</description>
    <arm_group_label>Conventional arterial puncture technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient admitted or treated in the acute emergency department&#xD;
&#xD;
          -  Indication for a arterial blood gas analysis, according to the physician responsible&#xD;
             for the patient's hospital stay / treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient age &lt; 16 years&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Christian B Laursen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Odense Universityhospital</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Odense University Hospital</name>
      <address>
        <city>Odense</city>
        <state>Fyn</state>
        <zip>5000</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>August 2013</verification_date>
  <study_first_submitted>July 16, 2012</study_first_submitted>
  <study_first_submitted_qc>August 8, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>August 2, 2013</last_update_submitted>
  <last_update_submitted_qc>August 2, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 5, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Odense University Hospital</investigator_affiliation>
    <investigator_full_name>Christian Borbjerg Laursen</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Wounds and Injuries</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/NCT01660724
org study id: Mulvarp2012
nct id: NCT01660724
lead sponsor: 
has dmc: No
The main purpose of the study is to evaluate whether the routine use of ultrasound guided
      arterial puncture can increase the proportion of patients who only needs one puncture attempt
      in order to successfully extract enough blood to make an arterial blood gas analysis, when
      ultrasound guided arterial puncture is compared to conventional arterial puncture technique.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Investigator)
measure: The proportion of patients who only needs one puncture attempt in order to successfully extract enough blood to make an arterial blood gas analysis
time frame: up to 1 hour after arterial puncture
measure: Time used for arterial puncture
time frame: up to 1 hour after arterial puncture
measure: Patient corporation
time frame: up to 1 hour after arterial puncture
description: Patient corporation is subjectively estimated by the physician performing the arterial puncture. The degree of patient corporation are assessed on a scale from 1 - 5, where 1 is very poor patient corporation and 5 is perfect patient corporation.
measure: Pain Scores on the Visual Analog Scale
time frame: Up to 1 hour after arterial puncture
measure: Number of attempts before successfully acquiring arterial puncture
time frame: up to 1 hour after arterial puncture
arm group label: Ultrasound guided arterial puncture
arm group type: Experimental
description: Patients randomised to the this arm has arterial puncture performed using simultaneously ultrasound in order to guide the passage of the syringe from the patient's skin to the artery
arm group label: Conventional arterial puncture technique
arm group type: Active Comparator
description: Patients randomised to the active comparator arm has arterial puncture performed using the conventional technique
intervention type: Procedure
intervention name: Ultrasound guided arterial puncture
description: Arterial puncture is performed using simultaneously ultrasound in order to guide the passage of the syringe from the patient's skin to the artery
arm group label: Ultrasound guided arterial puncture
intervention type: Procedure
intervention name: Conventional arterial puncture technique
description: Arterial puncture is performed using the conventional technique
arm group label: Conventional arterial puncture technique
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: No
last name: Christian B Laursen, MD
role: Principal Investigator
affiliation: Odense Universityhospital
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Odense University Hospital
investigator full name: Christian Borbjerg Laursen
investigator title: Principal investigator
mesh term: Wounds and Injuries