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

NCT ID: NCT03012893

Last Updated: 2017-01-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2017-01-31

Brief Summary

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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

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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.

Conditions

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Breastcancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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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

Group Type EXPERIMENTAL

Ultrasound transverse scan

Intervention Type DEVICE

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.

Ultrasound sagittal scan

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

Group Type EXPERIMENTAL

Ultrasound sagittal scan

Intervention Type DEVICE

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.

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.

Group Type ACTIVE_COMPARATOR

Fluoroscopic technique

Intervention Type PROCEDURE

C7 spinous process will be identified by counting down from C1 vertebral body and spinous process.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Fluoroscopic technique

C7 spinous process will be identified by counting down from C1 vertebral body and spinous process.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* healthy volunteer, age \>/= 18

Exclusion Criteria

* previous cervical spine surgery, cervical spine deformity, pregnancy
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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554/2559(EC2)

Identifier Type: -

Identifier Source: org_study_id

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