NCT00882297

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2009

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

April 15, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 16, 2009

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
Last Updated

January 21, 2010

Status Verified

January 1, 2010

Enrollment Period

7 months

First QC Date

April 15, 2009

Last Update Submit

January 20, 2010

Conditions

Cardiac Surgery

Keywords

Ultrasoundographycatheterizationcentral venous subclavian vein methods

Outcome Measures

Primary Outcomes (1)

  • Time from vein puncture to seldinger guide placement

    After anesthesia during cardiac surgery

Secondary Outcomes (1)

  • Complications

    During cardiac surgery until 48 hours after the end

Study Arms (2)

1

ACTIVE COMPARATOR

Transversal approach guided placement

Procedure: Echoguided vein puncture

2

ACTIVE COMPARATOR

Longitudinal approach guided placement

Procedure: Echoguided vein puncture

Interventions

Echoguided vein puncturePROCEDURE

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

12

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patient requiring the installation of a central venous catheter in subclavian site
  • Installation of catheter under general anaesthesia
  • Oral consent of the patient

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital, Bordeaux

Pessac, 33604, France

Location

Related Publications (3)

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

    PMID: 17414086BACKGROUND

  • 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.

    PMID: 12494802BACKGROUND

  • 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.

    PMID: 15720903BACKGROUND

Study Officials

  • Joachim CALDERON, MD

    University Hospital, Bordeeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 15, 2009

First Posted

April 16, 2009

Study Start

April 1, 2009

Primary Completion

November 1, 2009

Study Completion

November 1, 2009

Last Updated

January 21, 2010

Record last verified: 2010-01

Locations

FR(1)