NCT01647815

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Aug 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 17, 2012

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 24, 2012

Completed
8 days until next milestone

Study Start

First participant enrolled

August 1, 2012

Completed
9 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2012

Completed
Last Updated

November 19, 2025

Status Verified

March 1, 2015

Enrollment Period

9 days

First QC Date

July 17, 2012

Last Update Submit

November 17, 2025

Conditions

Keywords

Axillary vein ultrasoundSubclavian vein ultrasound

Outcome Measures

Primary Outcomes (3)

  • 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 Outcomes (27)

  • 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

    baseline (transversal); Day 0

  • Artery-vein distance (mm)

    baseline (transversal); Day 0

  • +22 more secondary outcomes

Study Arms (1)

50 healthy volunteers

EXPERIMENTAL

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

Interventions

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.

50 healthy volunteers

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • The volunteer is participating in another 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, 30029, France

Location

Related Publications (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.

  • 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.

Study Officials

  • Pascal Jeannes, MD

    Centre Hospitalier Universitaire de Nîmes

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 17, 2012

First Posted

July 24, 2012

Study Start

August 1, 2012

Primary Completion

August 10, 2012

Study Completion

August 10, 2012

Last Updated

November 19, 2025

Record last verified: 2015-03

Locations