Subclavian Vein Ultrasound Guided Cannulation in Adult

NCT ID: NCT00882297

Last Updated: 2010-01-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-11-30

Brief Summary

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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

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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.

Conditions

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Cardiac Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Participants

Study Groups

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1

Transversal approach guided placement

Group Type ACTIVE_COMPARATOR

Echoguided vein puncture

Intervention Type PROCEDURE

Puncture with echographic visualization of vein in transversal and longitudinal way.

2

Longitudinal approach guided placement

Group Type ACTIVE_COMPARATOR

Echoguided vein puncture

Intervention Type PROCEDURE

Puncture with echographic visualization of vein in transversal and longitudinal way.

Interventions

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Echoguided vein puncture

Puncture with echographic visualization of vein in transversal and longitudinal way.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Bordeaux

OTHER

Sponsor Role lead

Responsible Party

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University Hospital, Bordeaux

Principal Investigators

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Joachim CALDERON, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Bordeeaux

Locations

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University Hospital, Bordeaux

Pessac, , France

Site Status

Countries

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France

References

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Taylor RW, Palagiri AV. Central venous catheterization. Crit Care Med. 2007 May;35(5):1390-6. doi: 10.1097/01.CCM.0000260241.80346.1B.

Reference Type BACKGROUND
PMID: 17414086 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12494802 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15720903 (View on PubMed)

Other Identifiers

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CHUBX 2009/06

Identifier Type: -

Identifier Source: org_study_id

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