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Completed

NCT Number: NCT01543360

Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance

The main objective of this study is to compare the rate of successful establishment of a central venous catheter in the first two attempts of ultrasound-guided puncture between two techniques: (1) a subclavian technique versus (2) an axillary technique.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

CHU de Nîmes - Hôpital Universitaire Carémeau

Nîmes, Gard, 30029, France

About this study

The secondary objectives of this study are to compare the following between the two techniques:

  • the success rate of the establishment of a central venous catheter
  • the success rate of establishment of a central venous catheter at the first attempt at venipuncture
  • for non-failures (eg, a catheter is placed in the first four trys), time to cannulation
  • the presence / absence of the following complications:
  • arterial puncture (yes / no)
  • pneumothorax (yes / no)
  • hemothorax (yes / no)
  • hematoma (yes / no)
  • nerve injury (yes / no)
  • aberrant course (yes / no)

The reasons catheter placement failures will also be described.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The patient must have given his/her informed and signed consent
  • The patient must be insured or beneficiary of a health insurance plan
  • The patient is available for 24 hours of follow-up
  • Patient requiring the establishment of a central venous catheter

Exclusion criteria

  • The patient is in an exclusion period determined by a previous study
  • The patient is under judicial protection, under tutorship or curatorship
  • The patient refuses to sign the consent
  • It is impossible to correctly inform the patient
  • The patient is pregnant, parturient, or breastfeeding
  • Patient has a body mass index < 15 or > 40
  • Congenital or acquired anatomical deformity (radiation therapy, trauma, surgery) of the axillary and/or subclavian regions
  • Bleeding disorder (platelets < 50,000, prothrombine < 50%, activated cephaline time > 2 times the control value)
  • Severe hypoxemia defined by a ratio PaO2 / FIO2 < 100
  • Infection of the puncture area
  • Known thrombosis of the subclavian or axillary veins
  • Scheduled length of hospitalization less than 24 hours
  • Agitated or non-cooperative patient
  • The patient has already been included in this study
  • subclavian and axillary veins are not simultaneously echogenic on one or both sides (left and right).

Treatment and study plan

Axillary strategy

Procedure

The first two attempts at central venous catheterization will be performed via the distal approach (axillary vein). The third and fourth attempts at central venous catheterization will be performed by the medial approach (subclavian vein). The same puncture material/devices will be used in both arms of the study.

Subclavian strategy

Procedure

The first two attempts at central venous catheterization will be performed by the medial approach (subclavian vein). The third and fourth attempts at central venous catheterization will be performed by the distal approach (axillary vein). The same puncture material/devices will be used in both arms of the study.

Primary outcomes

  1. Central venous catheter established within first 2 puncture attempts

    Time frame: approximately 3 minutes

    yes/no

Secondary outcomes

  1. Central venous catheter established upon first punction attempt

    Time frame: approximately 3 minutes

    yes/no

  2. Establishment of a central venous catheter

    Time frame: approximately 3 minutes

    yes/no

  3. The time necessary for the establishment of a central venous catheter

    Time frame: approximately 3 minutes

    For non-failures (ie establishment of a central venous catheter within 4 puncture attempts), the number of minutes necessary for the establishment of a central venous catheter

  4. The time necessary for the establishment of a central venous catheter

    Time frame: approximately 3 minutes

    all cases, in minutes

  5. presence/absence of complications

    Time frame: Day 1

    arterial puncture (yes / no), pneumothorax (yes / no), hemothorax (yes / no), hematoma (yes / no), nerve injury (yes / no), aberrant course (yes / no)

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nīmes

Other

Registry information

Official study title

Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance: a Prospective, Randomized, Non-inferiority Study

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Mar 5, 2012
Registry last updated
Nov 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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