Subclavian Vein Ultrasound Guided Cannulation in Adult (CATETEL)

This study has been completed.
Sponsor:
Information provided by:
University Hospital, Bordeaux
ClinicalTrials.gov Identifier:
NCT00882297
First received: April 15, 2009
Last updated: January 20, 2010
Last verified: January 2010
  Purpose

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 Intervention
Cardiac Surgery
Procedure: Echoguided vein puncture

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Subclavian Vein Ultrasound Guided Cannulation in Adult: Transversal and Longitudinal Approach Comparison

Resource links provided by NLM:


Further study details as provided by University Hospital, Bordeaux:

Primary Outcome Measures:
  • Time from vein puncture to seldinger guide placement [ Time Frame: After anesthesia during cardiac surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Complications [ Time Frame: During cardiac surgery until 48 hours after the end ] [ Designated as safety issue: Yes ]

Enrollment: 100
Study Start Date: April 2009
Study Completion Date: November 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT00882297

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

Publications:
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
Study First Received: April 15, 2009
Last Updated: January 20, 2010
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

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

ClinicalTrials.gov processed this record on October 19, 2014