Clinical trial NCT01647815: Ultrasound Comparison of the Surface of the Subclavian and the Axillary Vein Versus the Surface of the Subclavian Vein
Official title: 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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy Volunteers
Keywords: Axillary vein ultrasound
Subclavian vein ultrasound
Lead sponsor: Centre Hospitalier Universitaire de Nīmes
Sponsor class: OTHER
First posted: 2012-07-24
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: 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.

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)

Eligibility criteria: 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

Primary outcomes:
measure: vein surface (mm^2), subclavian vein with arm along side the body
timeFrame: baseline (transversal); Day 0
measure: vein surface (mm^2), subclavian vein with arm in abduction and external rotation
timeFrame: baseline (transversal); Day 0
measure: vein surface (mm^2), axillary vein with arm along side the body
timeFrame: baseline (transversal); Day 0
Secondary outcomes:
measure: Vein depth (mm), subclavian vein with arms along side the body
timeFrame: baseline (transversal); Day 0
measure: Length of minor axis (mm), subclavian vein with arms along side the body
timeFrame: baseline (transversal); Day 0
measure: Length of major axis (mm), subclavian vein with arms along side the body
timeFrame: baseline (transversal); Day 0
measure: Artery-vein distance is displayed in the section plane? yes/no
timeFrame: baseline (transversal); Day 0
measure: Artery-vein distance (mm)
timeFrame: baseline (transversal); Day 0
measure: The vein-pleura distance is displayed in the section plane? yes/no
timeFrame: baseline (transversal); Day 0
measure: Vein-pleura distance (mm)
timeFrame: baseline (transversal); Day 0
measure: The distance to the brachial plexus is visualized in the sectional plane? yes/no
timeFrame: baseline (transversal); Day 0
measure: Distance to brachial plexus (mm)
timeFrame: baseline (transversal); Day 0
measure: Vein depth (mm), subclavian vein with arm in abduction and external rotation
timeFrame: baseline (transversal); Day 0
measure: Length of minor axis (mm), subclavian vein with arm in abduction and external rotation
timeFrame: baseline (transversal); Day 0
measure: Length of major axis (mm), subclavian vein with arm in abduction and external rotation
timeFrame: baseline (transversal); Day 0
measure: Vein depth (mm), axillary vein with arm along side the body
timeFrame: baseline (transversal); Day 0
measure: Length of minor axis (mm), axillary vein with arm along side the body
timeFrame: baseline (transversal); Day 0
measure: Length of major axis (mm), axillary vein with arm along side the body
timeFrame: baseline (transversal); Day 0
measure: Artery-vein distance is displayed in the section plane? yes/no
timeFrame: baseline (transversal); Day 0
measure: Artery-vein distance (mm)
timeFrame: baseline (transversal); Day 0
measure: The vein-pleura distance is displayed in the section plane? yes/no
timeFrame: baseline (transversal); Day 0
measure: The distance to the brachial plexus is visualized in the sectional plane? yes/no
timeFrame: baseline (transversal); Day 0
measure: Vein-pleura distance (mm)
timeFrame: baseline (transversal); Day 0
measure: Distance to brachial plexus (mm)
timeFrame: baseline (transversal); Day 0
measure: Artery-vein distance is displayed in the section plane? yes/no
timeFrame: baseline (transversal); Day 0
measure: Artery-vein distance (mm)
timeFrame: baseline (transversal); Day 0
measure: The vein-pleura distance is displayed in the section plane? yes/no
timeFrame: baseline (transversal); Day 0
measure: Vein-pleura distance (mm)
timeFrame: baseline (transversal); Day 0
measure: Distance to brachial plexus (mm)
timeFrame: baseline (transversal); Day 0
measure: The distance to the brachial plexus is visualized in the sectional plane? yes/no
timeFrame: baseline (transversal); Day 0
Other outcomes:
Locations:
city: Nîmes Cedex 09
country: France
facility: CHU de Nîmes - Hôpital Universitaire Carémeau
Study officials:
affiliation: Centre Hospitalier Universitaire de Nîmes
name: Pascal Jeannes, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.