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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01647815
First received: July 17, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Healthy Volunteers
Procedure: Ultrasound measures

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
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)

Resource links provided by NLM:


Further study details as provided by Centre Hospitalier Universitaire de Nīmes:

Primary Outcome Measures:
  • vein surface (mm^2), subclavian vein with arm along side the body [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • vein surface (mm^2), subclavian vein with arm in abduction and external rotation [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • vein surface (mm^2), axillary vein with arm along side the body [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Vein depth (mm), subclavian vein with arms along side the body [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • Length of minor axis (mm), subclavian vein with arms along side the body [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • Length of major axis (mm), subclavian vein with arms along side the body [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • Artery-vein distance is displayed in the section plane? yes/no [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    Ultrasound of subclavian vein with arm along side the body.

  • Artery-vein distance (mm) [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]

    Ultrasound of subclavian vein with arm along side the body.

    Artery-vein distance is displayed in the section plane? = yes


  • The vein-pleura distance is displayed in the section plane? yes/no [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    Ultrasound of subclavian vein with arm along side the body.

  • Vein-pleura distance (mm) [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]

    Ultrasound of subclavian vein with arm along side the body.

    The vein-pleura distance is displayed in the section plane? = yes


  • The distance to the brachial plexus is visualized in the sectional plane? yes/no [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    Ultrasound of subclavian vein with arm along side the body.

  • Distance to brachial plexus (mm) [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]

    Ultrasound of subclavian vein with arm along side the body.

    The distance of the brachial plexus is visualized in the sectional plane? = yes


  • Vein depth (mm), subclavian vein with arm in abduction and external rotation [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • Length of minor axis (mm), subclavian vein with arm in abduction and external rotation [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • Length of major axis (mm), subclavian vein with arm in abduction and external rotation [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • Vein depth (mm), axillary vein with arm along side the body [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • Length of minor axis (mm), axillary vein with arm along side the body [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • Length of major axis (mm), axillary vein with arm along side the body [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
  • Artery-vein distance is displayed in the section plane? yes/no [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    Ultrasound of subclavian vein with arm in abduction and external rotation.

  • Artery-vein distance (mm) [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]

    Ultrasound of subclavian vein with arm in abduction and external rotation.

    Artery-vein distance is displayed in the section plane? = yes


  • The vein-pleura distance is displayed in the section plane? yes/no [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    Ultrasound of subclavian vein with arm in abduction and external rotation.

  • The distance to the brachial plexus is visualized in the sectional plane? yes/no [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    Ultrasound of subclavian vein with arm in abduction and external rotation.

  • Vein-pleura distance (mm) [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]

    Ultrasound of subclavian vein with arm in abduction and external rotation.

    The vein-pleura distance is displayed in the section plane? = yes


  • Distance to brachial plexus (mm) [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]

    Ultrasound of subclavian vein with arm in abduction and external rotation.

    The distance of the brachial plexus is visualized in the sectional plane? = yes


  • Artery-vein distance is displayed in the section plane? yes/no [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    Ultrasound of axillary vein with arm along side the body.

  • Artery-vein distance (mm) [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]

    Ultrasound of axillary vein with arm along side the body.

    Artery-vein distance is displayed in the section plane? = yes


  • The vein-pleura distance is displayed in the section plane? yes/no [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    Ultrasound of axillary vein with arm along side the body.

  • Vein-pleura distance (mm) [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]

    Ultrasound of axillary vein with arm along side the body.

    The vein-pleura distance is displayed in the section plane? = yes


  • Distance to brachial plexus (mm) [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]

    Ultrasound of axillary vein with arm along side the body.

    The distance of the brachial plexus is visualized in the sectional plane? = yes


  • The distance to the brachial plexus is visualized in the sectional plane? yes/no [ Time Frame: baseline (transversal); Day 0 ] [ Designated as safety issue: No ]
    Ultrasound of axillary vein with arm along side the body.


Enrollment: 50
Study Start Date: August 2012
Study Completion Date: August 2012
Primary Completion Date: August 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Other Name: 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)
  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01647815

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Pascal Jeannes, MD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01647815     History of Changes
Other Study ID Numbers: LOCAL/2012/PJ-02, 2012-A00624-39
Study First Received: July 17, 2012
Last Updated: March 3, 2014
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
Axillary vein ultrasound
Subclavian vein ultrasound

ClinicalTrials.gov processed this record on September 18, 2014