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

NCT03012893 | Completed DMC

• 1 other identifier: 554/2559(EC2)
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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)

Conditions

Breastcancer

Keywords

ultrasonography to identify C7 spinous process

Outcome Measures

Primary Outcomes (1)

• 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)

  1 day

Study Arms (3)

Ultrasound transverse scan

EXPERIMENTAL

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

Ultrasound sagittal scan

EXPERIMENTAL

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

Device: Ultrasound sagittal scan

Floroscopic technique

ACTIVE COMPARATOR

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

Interventions

Ultrasound sagittal scan 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.

Ultrasound sagittal scan

Ultrasound transverse scan 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 transverse scan

Fluoroscopic technique PROCEDURE

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

Floroscopic technique

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• healthy volunteer, age \>/= 18

You may not qualify if:

• previous cervical spine surgery, cervical spine deformity, pregnancy

Sponsors & Collaborators

• Mahidol University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 5, 2017
• First Posted: January 6, 2017
• Study Start: December 1, 2016
• Primary Completion: December 1, 2016
• Study Completion: January 1, 2017
• Last Updated: January 18, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share