<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/NCT02217176</url>
  </required_header>
  <id_info>
    <org_study_id>31-662</org_study_id>
    <nct_id>NCT02217176</nct_id>
  </id_info>
  <brief_title>Ultrasonography of the Neck: The Influence of Airway Devices on Vascular Topography in Pediatric Patients</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Ankara University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Harran University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Ankara University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Internal jugular venous catheterization is a challenging procedure in pediatric patients due&#xD;
      to small size. Overlapping of the internal jugular vein (IJV) and common carotid artery (CCA)&#xD;
      may jeopardize the success and increase the complication rate.However, the use of ultrasound&#xD;
      as an assistance tool might be helpful to identify the relationship between the IJV and the&#xD;
      CCA. Endotracheal intubation and insertion of laryngeal mask are the common options for the&#xD;
      airway management during general anesthesia for central venous catheterization. In this&#xD;
      observational study, the investigators aimed to investigate the impact of the laryngeal mask&#xD;
      insertion or endotracheal intubation and the role of head rotation on the overlap of the IJV&#xD;
      and CCA evaluated with ultrasound in pediatric patients undergoing any kind of surgical&#xD;
      procedure.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2011</start_date>
  <completion_date type="Actual">January 2012</completion_date>
  <primary_completion_date type="Actual">January 2012</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Primary outcome is the overlap percentages (%) of right and left IJVs before and just after insertion of LMA compared with ETT. Overlap percentage is calculated as overlap of IJV(mm)/carotid artery diameter(mm))*100 obtained from ultrasonographic images.</measure>
    <time_frame>Obtaining ultrasonographic images takes 30 minutes on average per patient</time_frame>
    <description>The airway devices are identified according to the own preference of the responsible anesthesiologist regarding to the patient's status and the type of surgery.&#xD;
Ultrasonographic images of each patient are recorded bilaterally with a 8-12 MHz linear probe (Venue 40 GE, USA) at the cricoid cartilage level perpendicular to the skin, parallel to mandibula in neutral, 40o and 80o head away position. The same ultrasonographic evaluations are repeated after the airway device insertion. The images are then evaluated by three different anesthesiologist.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>the relationship between IJV and CCA defined as anterior, anterolateral, lateral, anteromedial and medial according to the IJV's topographic location</measure>
    <time_frame>Obtaining ultrasonographic images takes 30 minutes on average per patient</time_frame>
  </secondary_outcome>
  <other_outcome>
    <measure>the diameter of bilateral IJVs in mm</measure>
    <time_frame>Obtaining ultrasonographic images takes 30 minutes on average per patient</time_frame>
  </other_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">92</enrollment>
  <condition>Ultrasonography, Pediatrics, Overlap, Vascular Structures</condition>
  <arm_group>
    <arm_group_label>endotracheal intubation</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>laryngeal mask airway</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        The pediatric population who were undergone any type of surgery under general anesthesia&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  patients with American Society of Anesthesiologist status I-IV&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients with prior internal jugular vein catheterization or cardiovascular system&#xD;
             anomaly&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Ankara University Department of Anesthesiology and Intensive Care Medicine</name>
      <address>
        <city>Ankara</city>
        <zip>06590</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 10, 2014</study_first_submitted>
  <study_first_submitted_qc>August 14, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 15, 2014</study_first_posted>
  <last_update_submitted>August 14, 2014</last_update_submitted>
  <last_update_submitted_qc>August 14, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 15, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Ankara University</investigator_affiliation>
    <investigator_full_name>Menekse Ozcelik</investigator_full_name>
    <investigator_title>Specialist of Anesthesiology and Intensive Care Medicine</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/NCT02217176
org study id: 31-662
nct id: NCT02217176
lead sponsor: 
collaborator: 
has dmc: No
Internal jugular venous catheterization is a challenging procedure in pediatric patients due
      to small size. Overlapping of the internal jugular vein (IJV) and common carotid artery (CCA)
      may jeopardize the success and increase the complication rate.However, the use of ultrasound
      as an assistance tool might be helpful to identify the relationship between the IJV and the
      CCA. Endotracheal intubation and insertion of laryngeal mask are the common options for the
      airway management during general anesthesia for central venous catheterization. In this
      observational study, the investigators aimed to investigate the impact of the laryngeal mask
      insertion or endotracheal intubation and the role of head rotation on the overlap of the IJV
      and CCA evaluated with ultrasound in pediatric patients undergoing any kind of surgical
      procedure.
observational model: Cohort
time perspective: Cross-Sectional
measure: Primary outcome is the overlap percentages (%) of right and left IJVs before and just after insertion of LMA compared with ETT. Overlap percentage is calculated as overlap of IJV(mm)/carotid artery diameter(mm))*100 obtained from ultrasonographic images.
time frame: Obtaining ultrasonographic images takes 30 minutes on average per patient
description: The airway devices are identified according to the own preference of the responsible anesthesiologist regarding to the patient's status and the type of surgery.
Ultrasonographic images of each patient are recorded bilaterally with a 8-12 MHz linear probe (Venue 40 GE, USA) at the cricoid cartilage level perpendicular to the skin, parallel to mandibula in neutral, 40o and 80o head away position. The same ultrasonographic evaluations are repeated after the airway device insertion. The images are then evaluated by three different anesthesiologist.
measure: the relationship between IJV and CCA defined as anterior, anterolateral, lateral, anteromedial and medial according to the IJV's topographic location
time frame: Obtaining ultrasonographic images takes 30 minutes on average per patient
measure: the diameter of bilateral IJVs in mm
time frame: Obtaining ultrasonographic images takes 30 minutes on average per patient
arm group label: endotracheal intubation
arm group label: laryngeal mask airway
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 1 Month
maximum age: 16 Years
healthy volunteers: No
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: Ankara University
investigator full name: Menekse Ozcelik
investigator title: Specialist of Anesthesiology and Intensive Care Medicine