<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/NCT03252197</url>
  </required_header>
  <id_info>
    <org_study_id>1-2016-0081</org_study_id>
    <nct_id>NCT03252197</nct_id>
  </id_info>
  <brief_title>A Randomized Parallel Study for Simulated Internal Jugular Vein Cannulation Using Simple Needle Guide Device</brief_title>
  <official_title>A Randomized Parallel Study for Simulated Internal Jugular Vein Cannulation Using Simple Needle Guide Device</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yonsei University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yonsei University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Two-dimensional ultrasound guided approach does not guarantee first attempt success on&#xD;
      internal jugular vein cannulation. New attachable device recently was developed for accurate&#xD;
      needle insertion when ultrasound is used. Our randomized parallel simulation study will&#xD;
      examine whether this device will improve the first attempt success rate when ultrasound&#xD;
      guided internal jugular vein catheterization of simulated internal jugular vein.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a prospective, randomized, parallel trial using phantom simulating internal jugular&#xD;
      vein.&#xD;
&#xD;
      After informed consent all subjects will be randomized to insert needle for internal jugular&#xD;
      vein cannulation of phantom using ultrasound approach with or without this device. Video&#xD;
      camera will record all procedure process and ultrasound image in real time. Researchers&#xD;
      blinded to the study aim measured outcome variables based on recorded images.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 11, 2017</start_date>
  <completion_date type="Actual">June 24, 2017</completion_date>
  <primary_completion_date type="Actual">June 24, 2017</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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Blinded to study arm, Outcome assessor measured outcome variables based on recorded images.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>First attempt success</measure>
    <time_frame>Within 2 minutes or after start to insertion attempt</time_frame>
    <description>The first attempt success was defined as a successful attempt to perform a vein puncture in one attempt. The number of attempts was counted each time a subject inserted a guide needle into the phantom surface, followed by withdrawal, redirect, or reinsertion.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Posterior wall puncture of the internal jugular procedure, comfort level with procedure</measure>
    <time_frame>Within 2 minutes or after start to insertion attempt</time_frame>
    <description>It was defined when the needle tip on the recorded ultrasound screen was confirmed to pass through the posterior wall measurement unit : Yes or no (categorical variable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Carotid artery puncture</measure>
    <time_frame>Within 2 minutes or after start to insertion attempt</time_frame>
    <description>It was defined as the needle tip passing through the carotid lumen or the subject regurgitating artery water during cannulation attempt.&#xD;
measurement unit : Yes or no (categorical variable)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to cannulation</measure>
    <time_frame>Within 2 minutes or after start to insertion attempt</time_frame>
    <description>It was defined as the time from time out for procedure start to end point measurement unit : second</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Comfort level</measure>
    <time_frame>Within 2 minutes or after start to insertion attempt</time_frame>
    <description>It was defined subjective opinion about difficulty during procedure for each subject measurement unit : 100-mm visual analogue scale with 0 being the least of the difficulties and 10 being the highest.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">88</enrollment>
  <condition>Doctors Attending a Central Line Insertion Training Courses for New Residents of a University Hospital From March 2017 to June 2017</condition>
  <condition>Physicians Who Had Less Than 10 Ultrasound Guided Internal Jugular Vein Cannulation Participate in This Study</condition>
  <arm_group>
    <arm_group_label>New device group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>participants who are tested performance for ultrasound guided cannulation using device</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Conventional group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>participants who are tested performance for ultrasound guided cannulation using conventional method</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>UGIJVC with needle guide device</intervention_name>
    <description>Study subjects assigned to each group were trained in ultrasound guided internal jugular venous cannulation (UGIJVC) in separate spaces. On each session, subjects were educated about UGIJVC for 30 minutes, and the instructor who was in charge of session, consisted of experienced physicians who had 50 or more UGIJVC success experiences without a supervisor in clinical field. The instructors explained the anatomical structure and the principles of UGIJVC and then demonstrated the procedures directly to the subjects using phantom. After that, all subjects were instructed to perform hands on practice for 30 minutes. In case group, the instructor trained subjects using device. On the other hand in control group, UGIVJC was demonstrated as a conventional method of approaching the target vessel while confirming the needle tip on the ultrasound screen in real time without a device.</description>
    <arm_group_label>New device group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>UGIJVC without needle guide device</intervention_name>
    <description>participants who are tested performance for ultrasound guided cannulation using conventional method.</description>
    <arm_group_label>Conventional group</arm_group_label>
    <other_name>Conventional group</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Adults over 20&#xD;
&#xD;
          2. Resident in clinical hospital&#xD;
&#xD;
          3. Ultrasound-guided internal jugular vein insertion without supervisor experience less&#xD;
             than 10&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. If they have physical problem that is difficult to perform&#xD;
&#xD;
          2. If they do not want to participate in this study&#xD;
&#xD;
          3. If they can not understand the contents reading the informed consent&#xD;
&#xD;
          4. If they have more than 10 ultrasound guided internal jugular vein insertion without&#xD;
             supervisor&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Emergency Medicine, Yonsei University College of Medicine, Yonsei University Severance Hospital</name>
      <address>
        <city>Seoul</city>
        <zip>03722</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 28, 2017</study_first_submitted>
  <study_first_submitted_qc>August 14, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 17, 2017</study_first_posted>
  <last_update_submitted>August 14, 2017</last_update_submitted>
  <last_update_submitted_qc>August 14, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 17, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Ultrasound guided central venous cannulation</keyword>
  <keyword>new device</keyword>
  <keyword>first attempt success</keyword>
  <!-- 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/NCT03252197
org study id: 1-2016-0081
nct id: NCT03252197
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Two-dimensional ultrasound guided approach does not guarantee first attempt success on
      internal jugular vein cannulation. New attachable device recently was developed for accurate
      needle insertion when ultrasound is used. Our randomized parallel simulation study will
      examine whether this device will improve the first attempt success rate when ultrasound
      guided internal jugular vein catheterization of simulated internal jugular vein.
This was a prospective, randomized, parallel trial using phantom simulating internal jugular
      vein.

      After informed consent all subjects will be randomized to insert needle for internal jugular
      vein cannulation of phantom using ultrasound approach with or without this device. Video
      camera will record all procedure process and ultrasound image in real time. Researchers
      blinded to the study aim measured outcome variables based on recorded images.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Blinded to study arm, Outcome assessor measured outcome variables based on recorded images.
measure: First attempt success
time frame: Within 2 minutes or after start to insertion attempt
description: The first attempt success was defined as a successful attempt to perform a vein puncture in one attempt. The number of attempts was counted each time a subject inserted a guide needle into the phantom surface, followed by withdrawal, redirect, or reinsertion.
measure: Posterior wall puncture of the internal jugular procedure, comfort level with procedure
time frame: Within 2 minutes or after start to insertion attempt
description: It was defined when the needle tip on the recorded ultrasound screen was confirmed to pass through the posterior wall measurement unit : Yes or no (categorical variable)
measure: Carotid artery puncture
time frame: Within 2 minutes or after start to insertion attempt
description: It was defined as the needle tip passing through the carotid lumen or the subject regurgitating artery water during cannulation attempt.
measurement unit : Yes or no (categorical variable)
measure: Time to cannulation
time frame: Within 2 minutes or after start to insertion attempt
description: It was defined as the time from time out for procedure start to end point measurement unit : second
measure: Comfort level
time frame: Within 2 minutes or after start to insertion attempt
description: It was defined subjective opinion about difficulty during procedure for each subject measurement unit : 100-mm visual analogue scale with 0 being the least of the difficulties and 10 being the highest.
arm group label: New device group
arm group type: Experimental
description: participants who are tested performance for ultrasound guided cannulation using device
arm group label: Conventional group
arm group type: Active Comparator
description: participants who are tested performance for ultrasound guided cannulation using conventional method
intervention type: Device
intervention name: UGIJVC with needle guide device
description: Study subjects assigned to each group were trained in ultrasound guided internal jugular venous cannulation (UGIJVC) in separate spaces. On each session, subjects were educated about UGIJVC for 30 minutes, and the instructor who was in charge of session, consisted of experienced physicians who had 50 or more UGIJVC success experiences without a supervisor in clinical field. The instructors explained the anatomical structure and the principles of UGIJVC and then demonstrated the procedures directly to the subjects using phantom. After that, all subjects were instructed to perform hands on practice for 30 minutes. In case group, the instructor trained subjects using device. On the other hand in control group, UGIVJC was demonstrated as a conventional method of approaching the target vessel while confirming the needle tip on the ultrasound screen in real time without a device.
arm group label: New device group
intervention type: Device
intervention name: UGIJVC without needle guide device
description: participants who are tested performance for ultrasound guided cannulation using conventional method.
arm group label: Conventional group
other name: Conventional group
criteria: 
gender: All
minimum age: 20 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Sponsor