<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/NCT04432844</url>
  </required_header>
  <id_info>
    <org_study_id>IJV Protocol V2</org_study_id>
    <nct_id>NCT04432844</nct_id>
  </id_info>
  <brief_title>Ultrasound Guided Internal Jugular Vein Cannulation Using Biplanar Imaging: A Pilot Study</brief_title>
  <official_title>Ultrasound Guided Internal Jugular Vein Cannulation Using Biplanar Imaging: A Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Chinese University of Hong Kong</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Chinese University of Hong Kong</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>
      Central Venous access by real-time ultrasound guidance is considered as gold standard and a&#xD;
      recommended clinical practice. Internal jugular vein cannulation is one of the central venous&#xD;
      access commonly used for major cardiac surgeries for monitoring and administering life-saving&#xD;
      medications. In daily practice internal jugular vein cannulation is done under the guidance&#xD;
      of ultrasound imaging after general anesthesia before the surgery. Real time 2D ultrasound&#xD;
      guidance (USG) during central venous cannulation (CVC) has shown to be superior to the&#xD;
      traditional anatomical landmark guided CVC, but the incidence of carotid puncture is still&#xD;
      4.2%. Any improvement that aids in the ease and safety of the procedures needs to be&#xD;
      evaluated. Recently USG biplanar imaging can now successfully demonstrate real time imaging&#xD;
      in two different views at the same time. Theoretically, this may help improve precision by&#xD;
      improving real time needle tip visualization and thereby reduce potential complications as&#xD;
      compared to a traditional 2D approach. This study aims to assess the feasibility of biplanar&#xD;
      USG internal jugular venous cannulation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a single arm prospective observational pilot study conducted at Prince of Wales&#xD;
      Hospital in Hong Kong SAR. 20 adult patients scheduled for elective cardiac surgeries under&#xD;
      general anesthesia (GA) will be recruited. After GA, patients will be positioned in the head&#xD;
      low position for the USG guided IJV access. The skin of the neck will be prepared in a&#xD;
      standard aseptic fashion. After sterilization, the surrounding area will be covered with a&#xD;
      full-body sterile drape. The footprint and the cable of the ultrasound transducer will also&#xD;
      be covered with a sterile transparent cover. Sterile ultrasound gel will be used for acoustic&#xD;
      coupling during the USG guided CVC placement, but care will be taken to avoid inserting the&#xD;
      needle through the US gel.&#xD;
&#xD;
      USG XL 14-3 transducer will be used to obtain the biplanar imaging of IJV. A 3 lumen CVC will&#xD;
      be used to access the IJV. An experienced anesthesiologist shall perform the USG guided&#xD;
      procedure using the Seldinger method. This special transducer can provide real-time short&#xD;
      axis (out of the plane) and long axis (In-plane) view which can be used to identify, locate&#xD;
      and choose the introducer needle entry site for IJV vascular access. IJV will be assessed for&#xD;
      any anatomical variations, pre-existing pathologies and patency. Among the 'out of plane' and&#xD;
      'in plane' view, the former will be used as a primary view to guide the CVC introducer&#xD;
      needle. The reference mark/line in the primary 'out of the plane' image in the biplanar view&#xD;
      can be adjusted sidewise to visualise the needle in the 'in plane' view. As the needle is&#xD;
      visualised in the 'in plane' technique (figure 1), the relative position of the needle to the&#xD;
      target IJV can be determined which will further help in redirecting the needle towards the&#xD;
      IJV. Needle tip can be made visualised in the 'out of the plane' view by carefully moving the&#xD;
      transducer initially towards the introducer needle. Once the needle tip is visualised, it is&#xD;
      advanced further towards the target taking into consideration both the 'in plane' and 'out of&#xD;
      plane' image guidance. When the needle is visualised (in both the views) inside the vein, the&#xD;
      transducer will be kept aside, a 5 ml syringe will be used to aspirate blood and then the&#xD;
      guidewire is inserted into the IJV. Presence of guidewire will be again confirmed using the&#xD;
      same biplanar transducer before performing the dilatation of IJV and final passage of the&#xD;
      CVC. Likewise, the final position of the CVC shall also be confirmed using biplanar imaging.&#xD;
      After final confirmation, CVC will be secured safely to the neck using sutures and connected&#xD;
      to the pressure transducers for central venous pressure (CVP) monitoring.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 2, 2020</start_date>
  <completion_date type="Actual">November 30, 2020</completion_date>
  <primary_completion_date type="Actual">November 30, 2020</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Time taken for successful IJV cannulation</measure>
    <time_frame>Procedure (before surgery after general anesthesia)</time_frame>
    <description>The time taken from the skin puncture to the aspiration of blood</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of skin puncture</measure>
    <time_frame>from the start of IJV insertion till the end of the procedure</time_frame>
    <description>the number of skin puncture for the procedure</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>number of needle re-directions</measure>
    <time_frame>Procedure during IJV insertion</time_frame>
    <description>changes in the direction of needle insertion without removing it from the skin</description>
  </secondary_outcome>
  <enrollment type="Actual">20</enrollment>
  <condition>Cardiac Disease</condition>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Biplanar Ultrasound guided Internal Jugular Vein Cannulation</intervention_name>
    <description>Using Philips EPIQ elite ultrasound system with a high-frequency 3D and 4D volume linear array transducer (USG XL 14-3) to obtain the biplanar imaging of Internal jugular vein cannulation.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All patients scheduled for elective cardiac surgeries that meet the inclusion criteria will&#xD;
        be recruited.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  American Society of Anesthesiologists (ASA) physical status I to III&#xD;
&#xD;
          -  Patients posted for elective cardiac surgeries under general anaesthesia.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patient refusal&#xD;
&#xD;
          -  skin entry site infection&#xD;
&#xD;
          -  history of previous IJV cannulation&#xD;
&#xD;
          -  obese patients (BMI&gt;30)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Manoj K Karmakar, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Chinese University of Hong Kong</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Prince of Wales Hosptial</name>
      <address>
        <city>Shatin</city>
        <state>New Territories</state>
        <country>Hong Kong</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hong Kong</country>
  </location_countries>
  <verification_date>January 2021</verification_date>
  <study_first_submitted>June 12, 2020</study_first_submitted>
  <study_first_submitted_qc>June 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 16, 2020</study_first_posted>
  <last_update_submitted>January 26, 2021</last_update_submitted>
  <last_update_submitted_qc>January 26, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">January 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Chinese University of Hong Kong</investigator_affiliation>
    <investigator_full_name>Prof Manoj K Karmakar</investigator_full_name>
    <investigator_title>Professor</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Heart 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/NCT04432844
org study id: IJV Protocol V2
nct id: NCT04432844
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Central Venous access by real-time ultrasound guidance is considered as gold standard and a
      recommended clinical practice. Internal jugular vein cannulation is one of the central venous
      access commonly used for major cardiac surgeries for monitoring and administering life-saving
      medications. In daily practice internal jugular vein cannulation is done under the guidance
      of ultrasound imaging after general anesthesia before the surgery. Real time 2D ultrasound
      guidance (USG) during central venous cannulation (CVC) has shown to be superior to the
      traditional anatomical landmark guided CVC, but the incidence of carotid puncture is still
      4.2%. Any improvement that aids in the ease and safety of the procedures needs to be
      evaluated. Recently USG biplanar imaging can now successfully demonstrate real time imaging
      in two different views at the same time. Theoretically, this may help improve precision by
      improving real time needle tip visualization and thereby reduce potential complications as
      compared to a traditional 2D approach. This study aims to assess the feasibility of biplanar
      USG internal jugular venous cannulation.
This is a single arm prospective observational pilot study conducted at Prince of Wales
      Hospital in Hong Kong SAR. 20 adult patients scheduled for elective cardiac surgeries under
      general anesthesia (GA) will be recruited. After GA, patients will be positioned in the head
      low position for the USG guided IJV access. The skin of the neck will be prepared in a
      standard aseptic fashion. After sterilization, the surrounding area will be covered with a
      full-body sterile drape. The footprint and the cable of the ultrasound transducer will also
      be covered with a sterile transparent cover. Sterile ultrasound gel will be used for acoustic
      coupling during the USG guided CVC placement, but care will be taken to avoid inserting the
      needle through the US gel.

      USG XL 14-3 transducer will be used to obtain the biplanar imaging of IJV. A 3 lumen CVC will
      be used to access the IJV. An experienced anesthesiologist shall perform the USG guided
      procedure using the Seldinger method. This special transducer can provide real-time short
      axis (out of the plane) and long axis (In-plane) view which can be used to identify, locate
      and choose the introducer needle entry site for IJV vascular access. IJV will be assessed for
      any anatomical variations, pre-existing pathologies and patency. Among the 'out of plane' and
      'in plane' view, the former will be used as a primary view to guide the CVC introducer
      needle. The reference mark/line in the primary 'out of the plane' image in the biplanar view
      can be adjusted sidewise to visualise the needle in the 'in plane' view. As the needle is
      visualised in the 'in plane' technique (figure 1), the relative position of the needle to the
      target IJV can be determined which will further help in redirecting the needle towards the
      IJV. Needle tip can be made visualised in the 'out of the plane' view by carefully moving the
      transducer initially towards the introducer needle. Once the needle tip is visualised, it is
      advanced further towards the target taking into consideration both the 'in plane' and 'out of
      plane' image guidance. When the needle is visualised (in both the views) inside the vein, the
      transducer will be kept aside, a 5 ml syringe will be used to aspirate blood and then the
      guidewire is inserted into the IJV. Presence of guidewire will be again confirmed using the
      same biplanar transducer before performing the dilatation of IJV and final passage of the
      CVC. Likewise, the final position of the CVC shall also be confirmed using biplanar imaging.
      After final confirmation, CVC will be secured safely to the neck using sutures and connected
      to the pressure transducers for central venous pressure (CVP) monitoring.
observational model: Case-Only
time perspective: Prospective
measure: Time taken for successful IJV cannulation
time frame: Procedure (before surgery after general anesthesia)
description: The time taken from the skin puncture to the aspiration of blood
measure: number of skin puncture
time frame: from the start of IJV insertion till the end of the procedure
description: the number of skin puncture for the procedure
measure: number of needle re-directions
time frame: Procedure during IJV insertion
description: changes in the direction of needle insertion without removing it from the skin
intervention type: Procedure
intervention name: Biplanar Ultrasound guided Internal Jugular Vein Cannulation
description: Using Philips EPIQ elite ultrasound system with a high-frequency 3D and 4D volume linear array transducer (USG XL 14-3) to obtain the biplanar imaging of Internal jugular vein cannulation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Manoj K Karmakar, MD
role: Principal Investigator
affiliation: Chinese University of Hong Kong
facility: 
country: Hong Kong
responsible party type: Principal Investigator
investigator affiliation: Chinese University of Hong Kong
investigator full name: Prof Manoj K Karmakar
investigator title: Professor
mesh term: Heart Diseases