Ultrasound Comparison of the Surface of the Subclavian and the Axillary Vein Versus the Surface of the Subclavian Vein

Healthy Volunteers Clinical Trial

— AnatoAbord  

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01647815
• Other study ID #: LOCAL/2012/PJ-02
• Secondary ID: 2012-A00624-39
• Status: Completed
• Phase: N/A
• First received: July 17, 2012
• Last updated: March 25, 2015
• Start date: August 2012
• Est. completion date: August 2012

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Agence Nationale de Sécurité du Médicament et des produits de santéFrance: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: August 2012
• Est. primary completion date: August 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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 Design

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Healthy Volunteers

Intervention

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.

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vein surface (mm^2), subclavian vein with arm along side the body		baseline (transversal); Day 0	No
Primary	vein surface (mm^2), subclavian vein with arm in abduction and external rotation		baseline (transversal); Day 0	No
Primary	vein surface (mm^2), axillary vein with arm along side the body		baseline (transversal); Day 0	No
Secondary	Vein depth (mm), subclavian vein with arms along side the body		baseline (transversal); Day 0	No
Secondary	Length of minor axis (mm), subclavian vein with arms along side the body		baseline (transversal); Day 0	No
Secondary	Length of major axis (mm), subclavian vein with arms along side the body		baseline (transversal); Day 0	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Vein depth (mm), subclavian vein with arm in abduction and external rotation		baseline (transversal); Day 0	No
Secondary	Length of minor axis (mm), subclavian vein with arm in abduction and external rotation		baseline (transversal); Day 0	No
Secondary	Length of major axis (mm), subclavian vein with arm in abduction and external rotation		baseline (transversal); Day 0	No
Secondary	Vein depth (mm), axillary vein with arm along side the body		baseline (transversal); Day 0	No
Secondary	Length of minor axis (mm), axillary vein with arm along side the body		baseline (transversal); Day 0	No
Secondary	Length of major axis (mm), axillary vein with arm along side the body		baseline (transversal); Day 0	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No