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

January 15, 2017 updated by: Mahidol University

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.

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • healthy volunteer, age >/= 18

Exclusion Criteria:

  • previous cervical spine surgery, cervical spine deformity, pregnancy

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound transverse scan
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
Device: Ultrasound transverse scan
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.
Experimental: Ultrasound sagittal scan
Sagittal scan by identifying the first and second ribs and scan medially to depict the C7 transvers process.
Device: Ultrasound sagittal scan
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.
Active Comparator: Floroscopic technique
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.
Procedure: Fluoroscopic technique
C7 spinous process will be identified by counting down from C1 vertebral body and spinous process.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the accuracy of identify C7 spinous process
Time Frame: 1 day
the accuracy of two techniques (transverse scan and sagittal scan) using ultrasonography to identify C7 spinous process compare to the fluoroscope (standard technique)
1 day

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2016

Primary Completion (Actual)

December 1, 2016

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

January 5, 2017

First Submitted That Met QC Criteria

January 5, 2017

First Posted (Estimate)

January 6, 2017

Study Record Updates

Last Update Posted (Estimate)

January 18, 2017

Last Update Submitted That Met QC Criteria

January 15, 2017

Last Verified

January 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 554/2559(EC2)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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