<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/NCT02185664</url>
  </required_header>
  <id_info>
    <org_study_id>F.2/IEC/MAMC/11/No.96</org_study_id>
    <nct_id>NCT02185664</nct_id>
  </id_info>
  <brief_title>Use of Static Ultrasound Guidance for Internal Jugular Vein Cannulation in Adult Cardiac Surgical Patients</brief_title>
  <official_title>Comparison of the Landmark Technique and the Static Ultrasound Guided Technique for Internal Jugular Vein Cannulation in Adult Cardiac Surgical Patients.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Govind Ballabh Pant Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Govind Ballabh Pant Hospital</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Cannulation of the internal jugular vein (IJV) for central venous access is a standard&#xD;
      practice in cardiac surgery. In this study, the authors tested the hypothesis that using an&#xD;
      ultrasound (US) scanner would increase the success of IJV cannulation and decrease the&#xD;
      incidence of complications in adult cardiac surgical patients.&#xD;
&#xD;
      The study will include adult cardiac surgical patients, randomized into two groups (control&#xD;
      vs. US). In the control group, IJV cannulation will be performed by the conventional landmark&#xD;
      technique using Seldinger method. In the US group, the course of the IJV will be marked&#xD;
      before cannulation using a 2 - 4 MHz transthoracic echocardiography probe. The success rate,&#xD;
      number of attempts, cannulation time and complication rate will be compared for the two&#xD;
      groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Use of real time ultrasound has recently been recommended as the standard of care for&#xD;
      insertion of central venous catheters. However, its usage is limited by various factors which&#xD;
      include availability, space constraints and perceived lack of need according to surveys&#xD;
      including cardiovascular anesthesiologists. We will conduct a prospective randomized&#xD;
      controlled trial to compare the conventional landmark technique with the static ultrasound&#xD;
      (US) technique that utilized the transthoracic echocardiography (TTE) ultrasound probe which&#xD;
      is supplied along with the transesophageal echocardiography machines for internal jugular&#xD;
      vein cannulation in adult cardiac surgical patients.&#xD;
&#xD;
      After ethical committee approval and patient consent, adult patients scheduled for elective&#xD;
      cardiac surgery will be randomized to undergo internal jugular vein cannulation by either of&#xD;
      the two methods: standard landmark technique (group A: control group), static US technique&#xD;
      using the TTE probe (group B: ultrasound group). The success rate, number of attempts, total&#xD;
      cannulation time and complication rate in the two groups will be compared.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>April 2011</start_date>
  <completion_date type="Actual">April 2012</completion_date>
  <primary_completion_date type="Actual">April 2012</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>success</measure>
    <time_frame>during internal jugular venous cannulation</time_frame>
    <description>Success was defined as location of the IJV by the finder needle within five attempts.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>number of attempts by finder/locator needle</measure>
    <time_frame>at the time of internal jugular vein cannulation</time_frame>
    <description>The total number of attempts taken to locate the internal jugular vein using the locator/finder needle were measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total number of attempts by puncture needle</measure>
    <time_frame>at the time of internal jugular vein cannulation</time_frame>
    <description>The total number of attempts taken by the puncture needle to enter the internal jugular vein were measured.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>First attempt sucess</measure>
    <time_frame>at the time of internal jugular vein cannulation</time_frame>
    <description>First attempt success was defined as location of the IJV by finder needle in the first attempt.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central venous cannulation time</measure>
    <time_frame>at the time of internal jugular venous cannulation</time_frame>
    <description>Time to central venous cannulation (CVC) was defined as the time taken from the insertion of finder needle till de-airing and flushing of all the three ports of the triple lumen catheter.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ultrasound time</measure>
    <time_frame>at the time of internal jugular vein cannulation</time_frame>
    <description>The duration of ultrasound was defined as the time between the placement of the probe on neck till the marking of the course of the vein on the skin.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>total cannulation time</measure>
    <time_frame>at the time of internal jugular vein cannulation</time_frame>
    <description>control group: total cannulation time= central venous cannulation time ultrasound group: total cannulation time= central venous cannulation time+ ultrasound time</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>complication rate</measure>
    <time_frame>at the time of central venous cannulation</time_frame>
    <description>The complication rate was calculated as a percentage of the total number of complications with respect to the sample size</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">201</enrollment>
  <condition>Adult Cardiac Surgical Patients</condition>
  <arm_group>
    <arm_group_label>Landmark technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The landmark technique is the standard technique used for internal jugular vein cannulation.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Static Ultrasound technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Static ultrasound technique was used to assist internal jugular vein cannulation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>landmark technique</intervention_name>
    <description>The apex of the imaginary triangle formed between the two heads of sternocleidomastoid and clavicle was used as the point of needle entry, just lateral to the pulsation of the internal carotid artery and directed towards the ipsilateral nipple at an angle of 45 degrees.</description>
    <arm_group_label>Landmark technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Static Ultrasound technique</intervention_name>
    <description>Static ultrasound guided internal jugular vein cannulation was performed by using the transthoracic echocardiography probe supplied with the transesophageal echocardiography machine in the cardiothoracic surgery operation theatre. The internal jugular vein was located and marked using this method prior to puncture.</description>
    <arm_group_label>Static Ultrasound technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult patients scheduled for elective cardiac surgery&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients undergoing bidirectional Glenn shunt, Fontan surgery or emergency surgery&#xD;
&#xD;
          -  local site infection&#xD;
&#xD;
          -  presence of coagulopathy&#xD;
&#xD;
          -  anatomical deformity of neck(burns, neck swelling, surgical scar)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Deepak Tempe, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Govind Ballabh pant Hospital and Maulana azad Medical College, New Delhi, India</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Anesthesia and Intensive Care, Govind Ballabh Pant Hospital</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <reference>
    <citation>Espinet A, Dunning J. Does ultrasound-guided central line insertion reduce complications and time to placement in elective patients undergoing cardiac surgery. Interact Cardiovasc Thorac Surg. 2004 Sep;3(3):523-7. doi: 10.1016/j.icvts.2004.05.006.</citation>
    <PMID>17670301</PMID>
  </reference>
  <reference>
    <citation>Bailey PL, Glance LG, Eaton MP, Parshall B, McIntosh S. A survey of the use of ultrasound during central venous catheterization. Anesth Analg. 2007 Mar;104(3):491-7. doi: 10.1213/01.ane.0000255289.78333.c2.</citation>
    <PMID>17312193</PMID>
  </reference>
  <results_reference>
    <citation>Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003 Aug 16;327(7411):361. doi: 10.1136/bmj.327.7411.361.</citation>
    <PMID>12919984</PMID>
  </results_reference>
  <verification_date>July 2014</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 8, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>July 14, 2014</last_update_submitted>
  <last_update_submitted_qc>July 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Govind Ballabh Pant Hospital</investigator_affiliation>
    <investigator_full_name>Dr Deepti Saigal</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>internal jugular vein</keyword>
  <keyword>landmark</keyword>
  <keyword>ultrasound</keyword>
  <keyword>static</keyword>
  <keyword>cardiac surgery</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/NCT02185664
org study id: F.2/IEC/MAMC/11/No.96
nct id: NCT02185664
lead sponsor: 
has dmc: Yes
Cannulation of the internal jugular vein (IJV) for central venous access is a standard
      practice in cardiac surgery. In this study, the authors tested the hypothesis that using an
      ultrasound (US) scanner would increase the success of IJV cannulation and decrease the
      incidence of complications in adult cardiac surgical patients.

      The study will include adult cardiac surgical patients, randomized into two groups (control
      vs. US). In the control group, IJV cannulation will be performed by the conventional landmark
      technique using Seldinger method. In the US group, the course of the IJV will be marked
      before cannulation using a 2 - 4 MHz transthoracic echocardiography probe. The success rate,
      number of attempts, cannulation time and complication rate will be compared for the two
      groups.
Use of real time ultrasound has recently been recommended as the standard of care for
      insertion of central venous catheters. However, its usage is limited by various factors which
      include availability, space constraints and perceived lack of need according to surveys
      including cardiovascular anesthesiologists. We will conduct a prospective randomized
      controlled trial to compare the conventional landmark technique with the static ultrasound
      (US) technique that utilized the transthoracic echocardiography (TTE) ultrasound probe which
      is supplied along with the transesophageal echocardiography machines for internal jugular
      vein cannulation in adult cardiac surgical patients.

      After ethical committee approval and patient consent, adult patients scheduled for elective
      cardiac surgery will be randomized to undergo internal jugular vein cannulation by either of
      the two methods: standard landmark technique (group A: control group), static US technique
      using the TTE probe (group B: ultrasound group). The success rate, number of attempts, total
      cannulation time and complication rate in the two groups will be compared.
allocation: Randomized
intervention model: Parallel Assignment
masking: Single (Participant)
measure: success
time frame: during internal jugular venous cannulation
description: Success was defined as location of the IJV by the finder needle within five attempts.
measure: number of attempts by finder/locator needle
time frame: at the time of internal jugular vein cannulation
description: The total number of attempts taken to locate the internal jugular vein using the locator/finder needle were measured.
measure: total number of attempts by puncture needle
time frame: at the time of internal jugular vein cannulation
description: The total number of attempts taken by the puncture needle to enter the internal jugular vein were measured.
measure: First attempt sucess
time frame: at the time of internal jugular vein cannulation
description: First attempt success was defined as location of the IJV by finder needle in the first attempt.
measure: Central venous cannulation time
time frame: at the time of internal jugular venous cannulation
description: Time to central venous cannulation (CVC) was defined as the time taken from the insertion of finder needle till de-airing and flushing of all the three ports of the triple lumen catheter.
measure: ultrasound time
time frame: at the time of internal jugular vein cannulation
description: The duration of ultrasound was defined as the time between the placement of the probe on neck till the marking of the course of the vein on the skin.
measure: total cannulation time
time frame: at the time of internal jugular vein cannulation
description: control group: total cannulation time= central venous cannulation time ultrasound group: total cannulation time= central venous cannulation time+ ultrasound time
measure: complication rate
time frame: at the time of central venous cannulation
description: The complication rate was calculated as a percentage of the total number of complications with respect to the sample size
arm group label: Landmark technique
arm group type: Active Comparator
description: The landmark technique is the standard technique used for internal jugular vein cannulation.
arm group label: Static Ultrasound technique
arm group type: Experimental
description: Static ultrasound technique was used to assist internal jugular vein cannulation.
intervention type: Procedure
intervention name: landmark technique
description: The apex of the imaginary triangle formed between the two heads of sternocleidomastoid and clavicle was used as the point of needle entry, just lateral to the pulsation of the internal carotid artery and directed towards the ipsilateral nipple at an angle of 45 degrees.
arm group label: Landmark technique
intervention type: Device
intervention name: Static Ultrasound technique
description: Static ultrasound guided internal jugular vein cannulation was performed by using the transthoracic echocardiography probe supplied with the transesophageal echocardiography machine in the cardiothoracic surgery operation theatre. The internal jugular vein was located and marked using this method prior to puncture.
arm group label: Static Ultrasound technique
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Deepak Tempe, MD
role: Principal Investigator
affiliation: Govind Ballabh pant Hospital and Maulana azad Medical College, New Delhi, India
facility: 
country: India
citation: Espinet A, Dunning J. Does ultrasound-guided central line insertion reduce complications and time to placement in elective patients undergoing cardiac surgery. Interact Cardiovasc Thorac Surg. 2004 Sep;3(3):523-7. doi: 10.1016/j.icvts.2004.05.006.
PMID: 17670301
citation: Bailey PL, Glance LG, Eaton MP, Parshall B, McIntosh S. A survey of the use of ultrasound during central venous catheterization. Anesth Analg. 2007 Mar;104(3):491-7. doi: 10.1213/01.ane.0000255289.78333.c2.
PMID: 17312193
citation: Hind D, Calvert N, McWilliams R, Davidson A, Paisley S, Beverley C, Thomas S. Ultrasonic locating devices for central venous cannulation: meta-analysis. BMJ. 2003 Aug 16;327(7411):361. doi: 10.1136/bmj.327.7411.361.
PMID: 12919984
responsible party type: Principal Investigator
investigator affiliation: Govind Ballabh Pant Hospital
investigator full name: Dr Deepti Saigal
investigator title: Assistant Professor