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

Central Venous Catheterization Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01543360
• Other study ID #: LOCAL/2011/JYL-GB-01
• Secondary ID: 2011-A01353-38
• Status: Completed
• Phase: N/A
• First received: February 20, 2012
• Last updated: March 25, 2015
• Start date: June 2012
• Est. completion date: May 2013

Study information

• Verified date: March 2015
• Source: Centre Hospitalier Universitaire de Nimes
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)France: Committee for the Protection of Personnes
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Central Venous Catheterization

Intervention

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.
• 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.

Locations

Country	Name	City	State
France	CHU de Nîmes - Hôpital Universitaire Carémeau	Nîmes Cedex 09	Gard

Sponsors (1)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Nimes

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Central venous catheter established within first 2 puncture attempts	yes/no	approximately 3 minutes	Yes
Secondary	Central venous catheter established upon first punction attempt	yes/no	approximately 3 minutes	Yes
Secondary	Establishment of a central venous catheter	yes/no	approximately 3 minutes	Yes
Secondary	The time necessary for the establishment of a central venous catheter	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	approximately 3 minutes	Yes
Secondary	The time necessary for the establishment of a central venous catheter	all cases, in minutes	approximately 3 minutes	Yes
Secondary	presence/absence of complications	arterial puncture (yes / no), pneumothorax (yes / no), hemothorax (yes / no), hematoma (yes / no), nerve injury (yes / no), aberrant course (yes / no)	Day 1	Yes