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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier:
NCT01543360
First received: February 20, 2012
Last updated: March 3, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Central Venous Catheterization
Procedure: Axillary strategy
Procedure: Subclavian strategy

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance: a Prospective, Randomized, Non-inferiority Study

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

Primary Outcome Measures:
  • Central venous catheter established within first 2 puncture attempts [ Time Frame: approximately 3 minutes ] [ Designated as safety issue: Yes ]
    yes/no


Secondary Outcome Measures:
  • Central venous catheter established upon first punction attempt [ Time Frame: approximately 3 minutes ] [ Designated as safety issue: Yes ]
    yes/no

  • Establishment of a central venous catheter [ Time Frame: approximately 3 minutes ] [ Designated as safety issue: Yes ]
    yes/no

  • The time necessary for the establishment of a central venous catheter [ Time Frame: approximately 3 minutes ] [ Designated as safety issue: Yes ]
    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

  • The time necessary for the establishment of a central venous catheter [ Time Frame: approximately 3 minutes ] [ Designated as safety issue: Yes ]
    all cases, in minutes

  • presence/absence of complications [ Time Frame: Day 1 ] [ Designated as safety issue: Yes ]
    arterial puncture (yes / no), pneumothorax (yes / no), hemothorax (yes / no), hematoma (yes / no), nerve injury (yes / no), aberrant course (yes / no)


Enrollment: 132
Study Start Date: June 2012
Study Completion Date: May 2013
Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Axillary strategy
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).
Procedure: Axillary strategy
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.
Active Comparator: Subclavian strategy
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).
Procedure: Subclavian strategy
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.

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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).
  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: NCT01543360

Locations
France
CHU de Nîmes - Hôpital Universitaire Carémeau
Nîmes Cedex 09, Gard, France, 30029
Sponsors and Collaborators
Centre Hospitalier Universitaire de Nīmes
Investigators
Principal Investigator: Jean Yves Lefrant, MD PhD Centre Hospitalier Universitaire de Nîmes
  More Information

No publications provided

Responsible Party: Centre Hospitalier Universitaire de Nīmes
ClinicalTrials.gov Identifier: NCT01543360     History of Changes
Other Study ID Numbers: LOCAL/2011/JYL-GB-01, 2011-A01353-38
Study First Received: February 20, 2012
Last Updated: March 3, 2014
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
France: Committee for the Protection of Personnes

Keywords provided by Centre Hospitalier Universitaire de Nīmes:
axillary vein
sub clavian vein
comparison of strategies

ClinicalTrials.gov processed this record on August 28, 2014