Clinical trial NCT00882297: Subclavian Vein Ultrasound Guided Cannulation in Adult
Official title: Subclavian Vein Ultrasound Guided Cannulation in Adult: Transversal and Longitudinal Approach Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cardiac Surgery
Keywords: Ultrasoundography
catheterization
central venous subclavian vein methods
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2009-04-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time from vein puncture to seldinger guide placement
timeFrame: After anesthesia during cardiac surgery
Secondary outcomes:
measure: Complications
timeFrame: During cardiac surgery until 48 hours after the end
Other outcomes:
Locations:
city: Pessac
country: France
facility: University Hospital, Bordeaux
Study officials:
affiliation: University Hospital, Bordeeaux
name: Joachim CALDERON, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Taylor RW, Palagiri AV. Central venous catheterization. Crit Care Med. 2007 May;35(5):1390-6. doi: 10.1097/01.CCM.0000260241.80346.1B.
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. doi: 10.1016/s0750-7658(02)00778-5. French.
citation: 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. doi: 10.1308/1478708051441.