Ultrasound Comparison of the Surface of the Subclavian and the Axillary Vein Versus the Surface of the Subclavian Vein (AnatoAbord)

Ultrasound Comparison of the Surface of the Subclavian Vein (Arm in Abduction (90°) and External Rotation (90 °)) and the Surface of the Axillary Vein (Arms Along the Body) Versus the Surface of the Subclavian Vein (Arm Along the Body)

The main objective of this study is the demonstration of an increase of over 50% of the surface visible on ultrasound (mm2) of the axillary vein and subclavian vein in arm abduction (90 °) and external rotation (90 °) with respect to the surface of the subclavian vein along the arm body.

Study Overview

• Status: Completed
• Conditions: Healthy Volunteers
• Intervention / Treatment: Procedure: Ultrasound measures

Detailed Description

The secondary objective of this study is to investigate the anatomical relationships of these veins with the subclavian artery, the brachial plexus and the pleura, and assess the depth of the vein to the skin. Specifically, the following will be assessed:

• the depth of the vein (mm)
• the length of the minor axis (mm)
• the length of the major axis (mm)
• artery-vein distance (mm)
• vein-pleural distance (mm)
• the distance of the brachial plexus (mm)

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Nîmes Cedex 09, France, 30029
    • CHU de Nimes - Hopital Universitaire Caremeau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 50 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• The volunteer must have given his/her informed and signed consent
• The volunteer must be insured or beneficiary of a health insurance plan
• The volunteer is 18 to 50 years old

Exclusion Criteria:

• The volunteer is participating in another study
• The volunteer is in an exclusion period determined by a previous study
• The volunteer is under judicial protection, under tutorship or curatorship
• The volunteer refuses to sign the consent
• It is impossible to correctly inform the volunteer
• The volunteer is pregnant, parturient, or breastfeeding
• The volunteer has a contraindication for the exams in this study
• Volunteer with a history of trauma or surgery in the axilla or the shoulder girdle
• Volunteer with a known history of venous thrombosis in the axillary and / or subclavian veins

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 50 healthy volunteers; The study population consists of healthy volunteers aged 18 to 50 years and without previous surgery, trauma, or thrombosis of the axilla or the shoulder girdle.	Procedure: Ultrasound measures; Ultrasound will be used to measure the surfaces of the axillary and subclavian veins with the arms in different positions. Our goal is to compare the vein surface area available among different vein-position combinations. Our goal does not include testing specific devices.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
vein surface (mm^2), subclavian vein with arm along side the body	baseline (transversal); Day 0
vein surface (mm^2), subclavian vein with arm in abduction and external rotation	baseline (transversal); Day 0
vein surface (mm^2), axillary vein with arm along side the body	baseline (transversal); Day 0

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Vein depth (mm), subclavian vein with arms along side the body		baseline (transversal); Day 0
Length of minor axis (mm), subclavian vein with arms along side the body		baseline (transversal); Day 0
Length of major axis (mm), subclavian vein with arms along side the body		baseline (transversal); Day 0
Artery-vein distance is displayed in the section plane? yes/no	Ultrasound of subclavian vein with arm along side the body.	baseline (transversal); Day 0
Artery-vein distance (mm)	Ultrasound of subclavian vein with arm along side the body. Artery-vein distance is displayed in the section plane? = yes	baseline (transversal); Day 0
The vein-pleura distance is displayed in the section plane? yes/no	Ultrasound of subclavian vein with arm along side the body.	baseline (transversal); Day 0
Vein-pleura distance (mm)	Ultrasound of subclavian vein with arm along side the body. The vein-pleura distance is displayed in the section plane? = yes	baseline (transversal); Day 0
The distance to the brachial plexus is visualized in the sectional plane? yes/no	Ultrasound of subclavian vein with arm along side the body.	baseline (transversal); Day 0
Distance to brachial plexus (mm)	Ultrasound of subclavian vein with arm along side the body. The distance of the brachial plexus is visualized in the sectional plane? = yes	baseline (transversal); Day 0
Vein depth (mm), subclavian vein with arm in abduction and external rotation		baseline (transversal); Day 0
Length of minor axis (mm), subclavian vein with arm in abduction and external rotation		baseline (transversal); Day 0
Length of major axis (mm), subclavian vein with arm in abduction and external rotation		baseline (transversal); Day 0
Vein depth (mm), axillary vein with arm along side the body		baseline (transversal); Day 0
Length of minor axis (mm), axillary vein with arm along side the body		baseline (transversal); Day 0
Length of major axis (mm), axillary vein with arm along side the body		baseline (transversal); Day 0
Artery-vein distance is displayed in the section plane? yes/no	Ultrasound of subclavian vein with arm in abduction and external rotation.	baseline (transversal); Day 0
Artery-vein distance (mm)	Ultrasound of subclavian vein with arm in abduction and external rotation. Artery-vein distance is displayed in the section plane? = yes	baseline (transversal); Day 0
The vein-pleura distance is displayed in the section plane? yes/no	Ultrasound of subclavian vein with arm in abduction and external rotation.	baseline (transversal); Day 0
The distance to the brachial plexus is visualized in the sectional plane? yes/no	Ultrasound of subclavian vein with arm in abduction and external rotation.	baseline (transversal); Day 0
Vein-pleura distance (mm)	Ultrasound of subclavian vein with arm in abduction and external rotation. The vein-pleura distance is displayed in the section plane? = yes	baseline (transversal); Day 0
Distance to brachial plexus (mm)	Ultrasound of subclavian vein with arm in abduction and external rotation. The distance of the brachial plexus is visualized in the sectional plane? = yes	baseline (transversal); Day 0
Artery-vein distance is displayed in the section plane? yes/no	Ultrasound of axillary vein with arm along side the body.	baseline (transversal); Day 0
Artery-vein distance (mm)	Ultrasound of axillary vein with arm along side the body. Artery-vein distance is displayed in the section plane? = yes	baseline (transversal); Day 0
The vein-pleura distance is displayed in the section plane? yes/no	Ultrasound of axillary vein with arm along side the body.	baseline (transversal); Day 0
Vein-pleura distance (mm)	Ultrasound of axillary vein with arm along side the body. The vein-pleura distance is displayed in the section plane? = yes	baseline (transversal); Day 0
Distance to brachial plexus (mm)	Ultrasound of axillary vein with arm along side the body. The distance of the brachial plexus is visualized in the sectional plane? = yes	baseline (transversal); Day 0
The distance to the brachial plexus is visualized in the sectional plane? yes/no	Ultrasound of axillary vein with arm along side the body.	baseline (transversal); Day 0

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Nīmes
• Investigators: Principal Investigator: Pascal Jeannes, MD, Centre Hospitalier Universitaire de Nîmes

Publications and helpful links

General Publications

• Roger C, Sadek M, Bastide S, Jeannes P, Muller L, Bobbia X, Lefrant JY. Comparison of the visualisation of the subclavian and axillary veins: An ultrasound study in healthy volunteers. Anaesth Crit Care Pain Med. 2017 Feb;36(1):65-68. doi: 10.1016/j.accpm.2016.05.007. Epub 2016 Aug 2.
• Sadek M, Roger C, Bastide S, Jeannes P, Solecki K, de Jong A, Buzancais G, Elotmani L, Ripart J, Lefrant JY, Bobbia X, Muller L. The Influence of Arm Positioning on Ultrasonic Visualization of the Subclavian Vein: An Anatomical Ultrasound Study in Healthy Volunteers. Anesth Analg. 2016 Jul;123(1):129-32. doi: 10.1213/ANE.0000000000001327.

Study record dates

Study Major Dates

• Study Start: August 1, 2012
• Primary Completion (Actual): August 1, 2012
• Study Completion (Actual): August 1, 2012

Study Registration Dates

• First Submitted: July 17, 2012
• First Submitted That Met QC Criteria: July 19, 2012
• First Posted (Estimate): July 24, 2012

Study Record Updates

• Last Update Posted (Estimate): March 26, 2015
• Last Update Submitted That Met QC Criteria: March 25, 2015
• Last Verified: March 1, 2015

More Information

Terms related to this study

• Keywords: Axillary vein ultrasound; Subclavian vein ultrasound
• Other Study ID Numbers: LOCAL/2012/PJ-02; 2012-A00624-39 (Other Identifier: RCB number)