Safety Study of Subclavian and Internal Jugular Venous Catheterization

The recruitment status of this study is unknown because the information has not been verified recently.

Verified August 2011 by E-DA Hospital.
Recruitment status was Recruiting

Sponsor:

Information provided by (Responsible Party):

E-DA Hospital

ClinicalTrials.gov Identifier:

NCT01196962

First received: September 1, 2010

Last updated: November 22, 2012

Last verified: August 2011

History of Changes

Purpose

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.

Condition	Intervention
Time to Insertion Rates of Complications	Device: Central venous catheter


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety Study Intervention Model: Parallel Assignment Masking: Single Blind (Investigator) Primary Purpose: Treatment
Official Title:	A Randomize Controlled Trial to Compare the Complications of Subclavian and Internal Jugular Venous Catheterization in Critically Ill Patients

Further study details as provided by E-DA Hospital:

Primary Outcome Measures:

Time to completely insertion [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

rates of mechanical, infectious, and thrombotic complications [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]


Estimated Enrollment:	300
Study Start Date:	November 2010
Estimated Study Completion Date:	December 2013
Estimated Primary Completion Date:	December 2013 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Internal jugular vein	Device: Central venous catheter Central venous catheter insertion to subclavian vein Other Name: venous access

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.

Eligibility


Ages Eligible for Study:	20 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01196962

Contacts


Contact: Yu-Feng Wei, M.D.	+886-7-615-0011 ext 2980	ed102746@edah.org.tw

Locations


Taiwan
E-Da hospital	Recruiting
Kaohsiung, Taiwan, 7
Contact: Yu-Feng Wei, M.D. +886-7-615-0011 ext 2980 ed102746@edah.org.tw
Principal Investigator: Yu-Feng Wei, M.D.

Sponsors and Collaborators

E-DA Hospital

Investigators


Principal Investigator:	Yu-Feng Wei, M.D.	Chest department

More Information

No publications provided


Responsible Party:	E-DA Hospital
ClinicalTrials.gov Identifier:	NCT01196962 History of Changes
Other Study ID Numbers:	CSIS, EDAH
Study First Received:	September 1, 2010
Last Updated:	November 22, 2012
Health Authority:	Taiwan: Institutional Review Board

Keywords provided by E-DA Hospital:


central venous catheter complications internal jugular vein randomized trial subclavian vein

ClinicalTrials.gov processed this record on February 27, 2015

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