Subclavian Vein Ultrasound Guided Cannulation in Adult | NCT00882297

Studies
Subclavian Vein Ultrasound Guided Cannulation in Adult

NCT00882297

Sponsor

University Hospital, Bordeaux

Status

Completed

Last Update Posted

Jun 1, 2026Actual

Enrollment

100Actual

Phase

Not Applicable

Conditions

Cardiac Surgery

Interventions

Echoguided vein puncture

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2009-A00192-55	Other Identifier	ANSM

Status Module

Record Verification Date

Jan 2010

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2009

Primary Completion Date

Nov 2009Actual

Completion Date

Nov 2009Actual

First Submitted Date

Apr 15, 2009

First Submission Date that Met QC Criteria

Apr 15, 2009

First Posted Date

Apr 16, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 28, 2026

Last Update Posted Date

Jun 1, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

100Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Active Comparator	Transversal approach guided placement	Procedure: Echoguided vein puncture
2	Active Comparator	Longitudinal approach guided placement	Procedure: Echoguided vein puncture

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Echoguided vein puncture	Procedure	Puncture with echographic visualization of vein in transversal and longitudinal way.	1 2

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Time from vein puncture to seldinger guide placement		After anesthesia during cardiac surgery

Secondary Outcomes

Measure	Description	Time Frame
Complications		During cardiac surgery until 48 hours after the end

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Joachim CALDERON, MD	University Hospital, Bordeeaux	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Hospital, Bordeaux		Pessac		33604	France

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
17414086	Background	Taylor RW, Palagiri AV. Central venous catheterization. Crit Care Med. 2007 May;35(5):1390-6. doi: 10.1097/01.CCM.0000260241.80346.1B.
12494802	Background	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.