Safety Study of Subclavian and Internal Jugular Venous Catheterization

NCT01196962 — Not applicable, Unknown, 300 participants, E-DA Hospital

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A Randomize Controlled Trial to Compare the Complications of Subclavian and Internal Jugular Venous Catheterization in Critically Ill Patients

Registry	NCT01196962
Status	Unknown
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: single, treatment
Enrollment	300 (Estimated)
Sponsor	E-DA Hospital (Other)
Conditions	Time to Insertion, Rates of Complications
Interventions	Central venous catheter (Device)
Dates	start 2010-11-01, primary completion 2013-12-01 (estimated), completion 2013-12-01 (estimated), first posted 2010-09-09, last updated 2012-11-27
Locations	1 site in Taiwan

-Summary

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.

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+Detailed description

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.

+Arms and interventions

Arm	Type	Interventions	Description
Internal jugular vein	Experimental	Device: Central venous catheter

Central venous catheter (Device), also known as venous access: Central venous catheter insertion to subclavian vein

+Outcome measures

Primary outcomes

Time to completely insertion [1 hour]

Secondary outcomes

rates of mechanical, infectious, and thrombotic complications [14 days]

+Eligibility

Sex: All, ages: 20 Years to any

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

+Locations (1)

Facility	City	Country	Status
E-Da hospital	Kaohsiung City	Taiwan	Recruiting

+Investigators

Yu-Feng Wei, M.D., Principal investigator, Chest department