<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/NCT01690416</url>
  </required_header>
  <id_info>
    <org_study_id>sloth2</org_study_id>
    <secondary_id>Overlæge Dr. Med Edgar Schnohr</secondary_id>
    <nct_id>NCT01690416</nct_id>
  </id_info>
  <brief_title>Conventional vs Ultrasound Guided Arteria Cannulation.</brief_title>
  <official_title>Conventional vs Ultrasound Guided Arteria Cannulation</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarhus University Hospital Skejby</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aarhus University Hospital Skejby</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the project is to compare two methods for arterial cannulation. The traditional&#xD;
      method with ultrasound guided cannulation. The investigators goal is to improve this&#xD;
      procedure to reduce pain and complications.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The practice of placing vascular catheters is used many times every day at almost every&#xD;
      hospital. It is a safe procedure which generally does not imply problems. Though the&#xD;
      procedural optimum aren't reached. The procedure still fails some times and induce&#xD;
      complications. When the catheter is placed using the traditional method the pulse is palpated&#xD;
      by the operator's fingers. This is only to be done near the hand wrist. In this position the&#xD;
      catheter steadiness is fragile but because the pulse can't be sensed more proximal the&#xD;
      operator is forced to choose this position. This it though a problem that can be solved by&#xD;
      non invasive visualization technology. Ultrasound-guidance for central vascular access is&#xD;
      already well-established. However, in recent years ultrasound-guidance for peripheral&#xD;
      vascular access has gained popularity too. The evidence of multiple studies demonstrates&#xD;
      increased success rate and reduced complication rate with ultrasound compared to blind&#xD;
      landmark technique for vascular catheter placement.&#xD;
&#xD;
      In recent years there have been both procedural technique and technology improvements in the&#xD;
      field of ultrasound. This has led to the improvement of procedural catheterisation techniques&#xD;
      that now can be done by novices with higher attempt success rate than traditional method. One&#xD;
      technique that is gaining success is the short-axis-out-of-plane technique (SAX-OOP) with&#xD;
      dynamic-needle-tip-tracking (DNTT).Using the ultrasound machine the needle can be placed in a&#xD;
      more proximal direction on the forearm and the investigators believe that by the help of the&#xD;
      exposed procedure on the monitor many complications can be reduced.&#xD;
&#xD;
      It has been shown that inexperienced trainees lear the technique SAX-OOP and DNTT very&#xD;
      quickly.&#xD;
&#xD;
      First investigators hypothesize that the number of attempts, the number of withdrawals, the&#xD;
      time spend and the number of utilized catheters will be decreased using ultrasound vs. the&#xD;
      traditional method. Secondly investigators hypothesize that the pain induced by the&#xD;
      conventional method inclusive preoperational lidocaine injection will be the same or more&#xD;
      intense than using DNTT with local anesthesia. Thirdly investigators claim that the best&#xD;
      anatomical place to put the catheter isn't always corresponding with the spot chosen by&#xD;
      palpation, which increase the number of failures. Fourthly investigators hypothesize that the&#xD;
      use of ultrasound will increase the operator's subjective feeling of having accomplished a&#xD;
      successful procedure.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2012</start_date>
  <completion_date type="Actual">February 2013</completion_date>
  <primary_completion_date type="Actual">February 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>Crossover Assignment</intervention_model>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Attempts</measure>
    <time_frame>1 hour</time_frame>
    <description>The number of attempts (skin punctures) per catheterization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Withdrawals</measure>
    <time_frame>1 hour</time_frame>
    <description>The number of withdrawals of the guide-needle per catheterization</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Time consume</measure>
    <time_frame>minutes</time_frame>
    <description>The time spend for the catheterization procedure</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Catheters</measure>
    <time_frame>1 hour</time_frame>
    <description>The number of utilized catheters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain</measure>
    <time_frame>momentan</time_frame>
    <description>The pain induced by the conventional method inclusive preoperational lidocaine injection will be the same or more intense than using DNTT with local anesthesia measured on a VAS-score.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Ease of method for the operator</measure>
    <time_frame>momentan</time_frame>
    <description>The use of ultrasound will increase the operator's subjective feeling of having accomplished a successful procedure on a Likert scale.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Disorder of Cardiac Function</condition>
  <arm_group>
    <arm_group_label>Ultrasound DNTP</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>the catheter will be placed using ultrasound and DNTT and Lidocaine as local anesthesia, by the same fellow as the one who performs the puncture with the traditional method</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traditional palpation technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>arteria cannulation by traditional palpation technique, using preprocedural lidocaine for anesthetic and palpation method by a fellow</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Traditional palpation technique</intervention_name>
    <arm_group_label>Traditional palpation technique</arm_group_label>
    <arm_group_label>Ultrasound DNTP</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Ultrasound DNTP</intervention_name>
    <arm_group_label>Traditional palpation technique</arm_group_label>
    <arm_group_label>Ultrasound DNTP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age 20-90 years&#xD;
&#xD;
          -  Fulfill the criteria of an operation&#xD;
&#xD;
          -  Routine need of an arterial needle&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Lack of patient consent&#xD;
&#xD;
          -  Ultrasound identified plaques in the radial artery or ultrasound verified compromised&#xD;
             flow in either the radial or ulnar artery.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marlene Aa Hansen, stud.med</last_name>
    <role>Principal Investigator</role>
    <affiliation>Anæstesiologisk-Intensiv afd I</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarhus Universitets Hospital</name>
      <address>
        <city>Aarhus</city>
        <state>Jylland</state>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Denmark</country>
  </location_countries>
  <verification_date>May 2015</verification_date>
  <study_first_submitted>September 13, 2012</study_first_submitted>
  <study_first_submitted_qc>September 20, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 21, 2012</study_first_posted>
  <last_update_submitted>May 11, 2015</last_update_submitted>
  <last_update_submitted_qc>May 11, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 12, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Aarhus University Hospital Skejby</investigator_affiliation>
    <investigator_full_name>Marlene A Hansen, Stud.med</investigator_full_name>
    <investigator_title>Stud.med</investigator_title>
  </responsible_party>
  <!-- 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/NCT01690416
org study id: sloth2
secondary id: Overlæge Dr. Med Edgar Schnohr
nct id: NCT01690416
lead sponsor: 
has dmc: No
The aim of the project is to compare two methods for arterial cannulation. The traditional
      method with ultrasound guided cannulation. The investigators goal is to improve this
      procedure to reduce pain and complications.
The practice of placing vascular catheters is used many times every day at almost every
      hospital. It is a safe procedure which generally does not imply problems. Though the
      procedural optimum aren't reached. The procedure still fails some times and induce
      complications. When the catheter is placed using the traditional method the pulse is palpated
      by the operator's fingers. This is only to be done near the hand wrist. In this position the
      catheter steadiness is fragile but because the pulse can't be sensed more proximal the
      operator is forced to choose this position. This it though a problem that can be solved by
      non invasive visualization technology. Ultrasound-guidance for central vascular access is
      already well-established. However, in recent years ultrasound-guidance for peripheral
      vascular access has gained popularity too. The evidence of multiple studies demonstrates
      increased success rate and reduced complication rate with ultrasound compared to blind
      landmark technique for vascular catheter placement.

      In recent years there have been both procedural technique and technology improvements in the
      field of ultrasound. This has led to the improvement of procedural catheterisation techniques
      that now can be done by novices with higher attempt success rate than traditional method. One
      technique that is gaining success is the short-axis-out-of-plane technique (SAX-OOP) with
      dynamic-needle-tip-tracking (DNTT).Using the ultrasound machine the needle can be placed in a
      more proximal direction on the forearm and the investigators believe that by the help of the
      exposed procedure on the monitor many complications can be reduced.

      It has been shown that inexperienced trainees lear the technique SAX-OOP and DNTT very
      quickly.

      First investigators hypothesize that the number of attempts, the number of withdrawals, the
      time spend and the number of utilized catheters will be decreased using ultrasound vs. the
      traditional method. Secondly investigators hypothesize that the pain induced by the
      conventional method inclusive preoperational lidocaine injection will be the same or more
      intense than using DNTT with local anesthesia. Thirdly investigators claim that the best
      anatomical place to put the catheter isn't always corresponding with the spot chosen by
      palpation, which increase the number of failures. Fourthly investigators hypothesize that the
      use of ultrasound will increase the operator's subjective feeling of having accomplished a
      successful procedure.
allocation: Randomized
intervention model: Crossover Assignment
masking: Single (Participant)
measure: Attempts
time frame: 1 hour
description: The number of attempts (skin punctures) per catheterization
measure: Withdrawals
time frame: 1 hour
description: The number of withdrawals of the guide-needle per catheterization
measure: Time consume
time frame: minutes
description: The time spend for the catheterization procedure
measure: Catheters
time frame: 1 hour
description: The number of utilized catheters
measure: pain
time frame: momentan
description: The pain induced by the conventional method inclusive preoperational lidocaine injection will be the same or more intense than using DNTT with local anesthesia measured on a VAS-score.
measure: Ease of method for the operator
time frame: momentan
description: The use of ultrasound will increase the operator's subjective feeling of having accomplished a successful procedure on a Likert scale.
arm group label: Ultrasound DNTP
arm group type: Active Comparator
description: the catheter will be placed using ultrasound and DNTT and Lidocaine as local anesthesia, by the same fellow as the one who performs the puncture with the traditional method
arm group label: Traditional palpation technique
arm group type: Active Comparator
description: arteria cannulation by traditional palpation technique, using preprocedural lidocaine for anesthetic and palpation method by a fellow
intervention type: Procedure
intervention name: Traditional palpation technique
arm group label: Traditional palpation technique
arm group label: Ultrasound DNTP
intervention type: Procedure
intervention name: Ultrasound DNTP
arm group label: Traditional palpation technique
arm group label: Ultrasound DNTP
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Marlene Aa Hansen, stud.med
role: Principal Investigator
affiliation: Anæstesiologisk-Intensiv afd I
facility: 
country: Denmark
responsible party type: Principal Investigator
investigator affiliation: Aarhus University Hospital Skejby
investigator full name: Marlene A Hansen, Stud.med
investigator title: Stud.med