<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/NCT03012893</url>
  </required_header>
  <id_info>
    <org_study_id>554/2559(EC2)</org_study_id>
    <nct_id>NCT03012893</nct_id>
  </id_info>
  <brief_title>Identification of C7; Evaluations of 2 Sonographic Methods Using a Transverse and a Sagittal Scan.</brief_title>
  <official_title>Identification of the C7 Vertebral Level; Evaluations of Two Sonographic Methods Using a Transverse Scan of the C7 Transverse Process and a Sagittal Scan of the First Rib.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mahidol University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mahidol University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      To determine the accuracy of two techniques (transverse scan and sagittal scan) using&#xD;
      ultrasonography to identify C7 spinous process compare to the fluoroscope (standard&#xD;
      technique)&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      To identify the accurate level of upper thoracic spine is essential maneuver during breast&#xD;
      surgery and axillary node dissection. Palpation C7 spinous process is most common technique&#xD;
      using to identify the level. However, the accuracy was lower than 50%. Ultrasonography has&#xD;
      been investigated to identify the cervical nerve roots by differentiating the transvers&#xD;
      process of C6 and C7. However, there was no study on the accuracy of using ultrasound to&#xD;
      identify cervical spine level before.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2016</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">December 2016</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>Diagnostic</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>the accuracy of identify C7 spinous process</measure>
    <time_frame>1 day</time_frame>
    <description>the accuracy of two techniques (transverse scan and sagittal scan) using ultrasonography to identify C7 spinous process compare to the fluoroscope (standard technique)</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Breastcancer</condition>
  <arm_group>
    <arm_group_label>Ultrasound transverse scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Transvers scan by identifying the C7 transvers process using vertebral artery and absence of anterior tubercle as a landmark and then scan back following articular process, lamina and then find out the spinous process of C7</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ultrasound sagittal scan</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Sagittal scan by identifying the first and second ribs and scan medially to depict the C7 transvers process.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Floroscopic technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fluoroscopy image will do on lateral view including all cervical spines and upper thoracic spines. C7 spinous process will be identified by counting down from C1 vertebral body and spinous process.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound sagittal scan</intervention_name>
    <description>Convex transducer will be placed at patient's neck using paramedian sagittal scan and pointing toward the chest apex aiming to identify the first rib. Then move the transducer medially to identify the transverse process along with identify C7 transverse process will appear on the image as a hyperechoic shadow without continue to the rib laterally. Place the C7 spinous process on the midpoint of the probe and the spinous process correspondence to the midline will be marked as C7.</description>
    <arm_group_label>Ultrasound sagittal scan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultrasound transverse scan</intervention_name>
    <description>Linear transducer will be placed at patient's lateral neck using transverse scan. The unique characteristic of sonography of transvers process of C6 and C7 will be used to identify the transverse process of C6 and C7. C6 transverse process has a very prominence anterior tubercle (known as Chassaignac tubercle). While anterior tubercle of C7 is absent. After identifying the C7 transverse process, simultaneously the color Doppler mode will be activated to identify the vertebral artery for double confirmation.</description>
    <arm_group_label>Ultrasound transverse scan</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Fluoroscopic technique</intervention_name>
    <description>C7 spinous process will be identified by counting down from C1 vertebral body and spinous process.</description>
    <arm_group_label>Floroscopic technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy volunteer, age &gt;/= 18&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  previous cervical spine surgery, cervical spine deformity, pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 5, 2017</study_first_submitted>
  <study_first_submitted_qc>January 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 6, 2017</study_first_posted>
  <last_update_submitted>January 15, 2017</last_update_submitted>
  <last_update_submitted_qc>January 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>ultrasonography to identify C7 spinous process</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Breast Neoplasms</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <pending_results>
    <submitted>March 10, 2019</submitted>
    <returned>April 1, 2019</returned>
  </pending_results>
  <!-- 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/NCT03012893
org study id: 554/2559(EC2)
nct id: NCT03012893
lead sponsor: 
has dmc: Yes
To determine the accuracy of two techniques (transverse scan and sagittal scan) using
      ultrasonography to identify C7 spinous process compare to the fluoroscope (standard
      technique)
To identify the accurate level of upper thoracic spine is essential maneuver during breast
      surgery and axillary node dissection. Palpation C7 spinous process is most common technique
      using to identify the level. However, the accuracy was lower than 50%. Ultrasonography has
      been investigated to identify the cervical nerve roots by differentiating the transvers
      process of C6 and C7. However, there was no study on the accuracy of using ultrasound to
      identify cervical spine level before.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: Single (Outcomes Assessor)
measure: the accuracy of identify C7 spinous process
time frame: 1 day
description: the accuracy of two techniques (transverse scan and sagittal scan) using ultrasonography to identify C7 spinous process compare to the fluoroscope (standard technique)
arm group label: Ultrasound transverse scan
arm group type: Experimental
description: Transvers scan by identifying the C7 transvers process using vertebral artery and absence of anterior tubercle as a landmark and then scan back following articular process, lamina and then find out the spinous process of C7
arm group label: Ultrasound sagittal scan
arm group type: Experimental
description: Sagittal scan by identifying the first and second ribs and scan medially to depict the C7 transvers process.
arm group label: Floroscopic technique
arm group type: Active Comparator
description: Fluoroscopy image will do on lateral view including all cervical spines and upper thoracic spines. C7 spinous process will be identified by counting down from C1 vertebral body and spinous process.
intervention type: Device
intervention name: Ultrasound sagittal scan
description: Convex transducer will be placed at patient's neck using paramedian sagittal scan and pointing toward the chest apex aiming to identify the first rib. Then move the transducer medially to identify the transverse process along with identify C7 transverse process will appear on the image as a hyperechoic shadow without continue to the rib laterally. Place the C7 spinous process on the midpoint of the probe and the spinous process correspondence to the midline will be marked as C7.
arm group label: Ultrasound sagittal scan
intervention type: Device
intervention name: Ultrasound transverse scan
description: Linear transducer will be placed at patient's lateral neck using transverse scan. The unique characteristic of sonography of transvers process of C6 and C7 will be used to identify the transverse process of C6 and C7. C6 transverse process has a very prominence anterior tubercle (known as Chassaignac tubercle). While anterior tubercle of C7 is absent. After identifying the C7 transverse process, simultaneously the color Doppler mode will be activated to identify the vertebral artery for double confirmation.
arm group label: Ultrasound transverse scan
intervention type: Procedure
intervention name: Fluoroscopic technique
description: C7 spinous process will be identified by counting down from C1 vertebral body and spinous process.
arm group label: Floroscopic technique
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Breast Neoplasms
sharing ipd: No
submitted: March 10, 2019
returned: April 1, 2019