Subclavian Vein Ultrasound Guided Cannulation in Adult

Cardiac Surgery Clinical Trial

— CATETEL  

Official title:

Subclavian Vein Ultrasound Guided Cannulation in Adult: Transversal and Longitudinal Approach Comparison

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00882297
• Other study ID #: CHUBX 2009/06
• Status: Completed
• Phase: N/A
• First received: April 15, 2009
• Last updated: January 20, 2010
• Start date: April 2009
• Est. completion date: November 2009

Study information

• Verified date: January 2010
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial Summary

There is actually two techniques of subclavian vein ultrasonography-guided venous catheterization : the axial and longitudinal approach. Currently, nothing makes it possible to privilege one technique compared to the other. This study aims to determine the best ultrasonography-guided method.

Description:

This prospective randomized study will concern 100 adult patients operated of cardiac surgery under general anesthesia and requiring a central venous catheter. Patients will be randomized by an operator experienced in echoguided venous catheterization to be included in the axial (50 patients) or the longitudinal (50 patients) approach group. The device used will be a vascular probe of 7.5 MHz (Sonosite I Look®). The principal outcome measure will be the time from percutaneous puncture to the rise of the metallic guide (seldinger technique). The secondary criteria will be the rate of complication and failure. A series of echographic (size and depth of the subclavian vein and biometric (BMI, theoretical distance not from puncture (way of Aubaniac)/réel) measurements will be done to identify predictive conditions of success or failure depending of the echographic approach.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: November 2009
• Est. primary completion date: November 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient requiring the installation of a central venous catheter in subclavian site

• Installation of catheter under general anaesthesia

• Oral consent of the patient

Exclusion Criteria:

• Thrombosis in subclavian vein

• Urgency of central venous catheterization.

• Insertion of central vein catheter other than subclavian

• Insertion of subclavian catheter under loco-regional anaesthesia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Cardiac Surgery

Intervention

Procedure:
• Echoguided vein puncture
Puncture with echographic visualization of vein in transversal and longitudinal way.

Locations

Country	Name	City	State
France	University Hospital, Bordeaux	Pessac

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

References & Publications (3)

Brooks AJ, Alfredson M, Pettigrew B, Morris DL. Ultrasound-guided insertion of subclavian venous access ports. Ann R Coll Surg Engl. 2005 Jan;87(1):25-7. — View Citation

Forestier F, Rossi H, Calderon J, Soubiron L, Bourdarias B, Janvier G. [Training for adult subclavian venous catheterization: use of real-time echography]. Ann Fr Anesth Reanim. 2002 Nov;21(9):698-702. French. — View Citation

Taylor RW, Palagiri AV. Central venous catheterization. Crit Care Med. 2007 May;35(5):1390-6. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time from vein puncture to seldinger guide placement		After anesthesia during cardiac surgery	Yes
Secondary	Complications		During cardiac surgery until 48 hours after the end	Yes