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Subclavian Vein Ultrasound Guided Cannulation in Adult (CATETEL)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00882297
Recruitment Status : Completed
First Posted : April 16, 2009
Last Update Posted : January 21, 2010
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment
Cardiac Surgery Procedure: Echoguided vein puncture

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Supportive Care
Official Title: Subclavian Vein Ultrasound Guided Cannulation in Adult: Transversal and Longitudinal Approach Comparison
Study Start Date : April 2009
Primary Completion Date : November 2009
Study Completion Date : November 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Transversal approach guided placement
Procedure: Echoguided vein puncture
Puncture with echographic visualization of vein in transversal and longitudinal way.
Active Comparator: 2
Longitudinal approach guided placement
Procedure: Echoguided vein puncture
Puncture with echographic visualization of vein in transversal and longitudinal way.

Outcome Measures

Primary Outcome Measures :
  1. Time from vein puncture to seldinger guide placement [ Time Frame: After anesthesia during cardiac surgery ]

Secondary Outcome Measures :
  1. Complications [ Time Frame: During cardiac surgery until 48 hours after the end ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00882297

University Hospital, Bordeaux
Pessac, France, 33604
Sponsors and Collaborators
University Hospital, Bordeaux
Principal Investigator: Joachim CALDERON, MD University Hospital, Bordeeaux
More Information

Responsible Party: Jean-Pierre LEROY / Clinical Research and Innovation Director, University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT00882297     History of Changes
Other Study ID Numbers: CHUBX 2009/06
First Posted: April 16, 2009    Key Record Dates
Last Update Posted: January 21, 2010
Last Verified: January 2010

Keywords provided by University Hospital, Bordeaux:
central venous subclavian vein methods