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Safety Study of Subclavian and Internal Jugular Venous Catheterization

NCT ID: NCT01196962

Last Updated: 2012-11-27

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-30

Study Completion Date

2013-12-31

Brief Summary

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There is no randomized controlled trial to compare the rates of complications associated with internal jugular and subclavian venous catheterization. The aim of this study is to compare mechanical, infectious, and thrombotic complications of internal jugular and subclavian venous catheterization. An improved understanding of CVC-related risks might help clinicians to choose one approach over the other in specific clinical settings.

Detailed Description

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Central venous catheterization is often necessary to treat critically ill patients hospitalized in intensive care units (ICUs). However, this procedure may lead to serious and sometimes life-threatening complications, including mechanical, infectious, or thrombotic complications. The choice of insertion site can influence the incidence and type of such complications. The most frequently used sites for CVC insertion are the internal jugular and the subclavian vein. However, in an individual patient, criteria for choosing one approach over the other remain unclear.

Conditions

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Time to Insertion Rates of Complications

Keywords

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central venous catheter complications internal jugular vein randomized trial subclavian vein

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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Internal jugular vein

Group Type EXPERIMENTAL

Central venous catheter

Intervention Type DEVICE

Central venous catheter insertion to subclavian vein

Interventions

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Central venous catheter

Central venous catheter insertion to subclavian vein

Intervention Type DEVICE

Other Intervention Names

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venous access

Eligibility Criteria

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Inclusion Criteria

* admission to ICU
* requiring central venous catheterization
* without contraindications to attempt both jugular and internal jugular access

Exclusion Criteria

* the presence of a central venous catheter at admission
* central venous catheterization within 2 weeks prior to admission
* emergency catheterization for a life-threatening situation
* major blood coagulation disorders
* anatomic defect precluding catheterization at either site
* skin lesions or recent surgery at either site
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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E-DA Hospital

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Yu-Feng Wei, M.D.

Role: PRINCIPAL_INVESTIGATOR

Chest department

Locations

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E-Da hospital

Kaohsiung City, , Taiwan

Site Status RECRUITING

Countries

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Taiwan

Central Contacts

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Yu-Feng Wei, M.D.

Role: CONTACT

Phone: +886-7-615-0011

Email: [email protected]

Facility Contacts

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Yu-Feng Wei, M.D.

Role: primary

Other Identifiers

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EDAH

Identifier Type: OTHER

Identifier Source: secondary_id

CSIS

Identifier Type: -

Identifier Source: org_study_id