Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance - Full Text View

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)

Estimated Enrollment:	132
Study Start Date:	May 2012
Estimated Study Completion Date:	June 2014
Estimated Primary Completion Date:	June 2014 (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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01543360

Contacts

Contact: Jean Yves Lefrant, MD PhD	+33.(0)4.66.68.30.50	jean.yves.lefrant@chu-nimes.fr
Contact: Carey Suehs, PhD	+33.(0)4.66.68.67.88	carey.suehs@chu-nimes.fr

Locations

France
CHU de Nîmes - Hôpital Universitaire Carémeau	Recruiting
Nîmes Cedex 09, Gard, France, 30029
Principal Investigator: Jean Yves Lefrant, MD PhD
Sub-Investigator: Gautier Buzancais
Sub-Investigator: Christian Bengler, MD PhD
Sub-Investigator: Pascal Jeannes, MD
Sub-Investigator: Guillaume Louart, MD
Sub-Investigator: Laurent Muller, MD
Sub-Investigator: Jacques Ripart, MD PhD
Sub-Investigator: Alban Brougère, MD PhD

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 26, 2013
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 May 23, 2013