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Identification of C7; Evaluations of 2 Sonographic Methods Using a Transverse and a Sagittal Scan.

Primary Purpose

Breastcancer

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Ultrasound sagittal scan
Ultrasound transverse scan
Fluoroscopic technique
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Breastcancer focused on measuring ultrasonography to identify C7 spinous process

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy volunteer, age >/= 18

Exclusion Criteria:

  • previous cervical spine surgery, cervical spine deformity, pregnancy

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    Active Comparator

    Arm Label

    Ultrasound transverse scan

    Ultrasound sagittal scan

    Floroscopic technique

    Arm 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

    Sagittal scan by identifying the first and second ribs and scan medially to depict the C7 transvers process.

    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.

    Outcomes

    Primary Outcome Measures

    the accuracy of identify C7 spinous process
    the accuracy of two techniques (transverse scan and sagittal scan) using ultrasonography to identify C7 spinous process compare to the fluoroscope (standard technique)

    Secondary Outcome Measures

    Full Information

    First Posted
    January 5, 2017
    Last Updated
    January 15, 2017
    Sponsor
    Mahidol University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03012893
    Brief Title
    Identification of C7; Evaluations of 2 Sonographic Methods Using a Transverse and a Sagittal Scan.
    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.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2016 (undefined)
    Primary Completion Date
    December 2016 (Actual)
    Study Completion Date
    January 2017 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Mahidol University

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    Brief Summary
    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)
    Detailed Description
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Breastcancer
    Keywords
    ultrasonography to identify C7 spinous process

    7. Study Design

    Primary Purpose
    Diagnostic
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Outcomes Assessor
    Allocation
    Randomized
    Enrollment
    20 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Ultrasound transverse scan
    Arm Type
    Experimental
    Arm 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 Title
    Ultrasound sagittal scan
    Arm Type
    Experimental
    Arm Description
    Sagittal scan by identifying the first and second ribs and scan medially to depict the C7 transvers process.
    Arm Title
    Floroscopic technique
    Arm Type
    Active Comparator
    Arm 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(s)
    Ultrasound sagittal scan
    Intervention 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.
    Intervention Type
    Device
    Intervention Name(s)
    Ultrasound transverse scan
    Intervention 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.
    Intervention Type
    Procedure
    Intervention Name(s)
    Fluoroscopic technique
    Intervention Description
    C7 spinous process will be identified by counting down from C1 vertebral body and spinous process.
    Primary Outcome Measure Information:
    Title
    the accuracy of identify C7 spinous process
    Description
    the accuracy of two techniques (transverse scan and sagittal scan) using ultrasonography to identify C7 spinous process compare to the fluoroscope (standard technique)
    Time Frame
    1 day

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: healthy volunteer, age >/= 18 Exclusion Criteria: previous cervical spine surgery, cervical spine deformity, pregnancy

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Identification of C7; Evaluations of 2 Sonographic Methods Using a Transverse and a Sagittal Scan.

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