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Safety Study of Subclavian and Internal Jugular Venous Catheterization

This study is currently recruiting participants.
Verified August 2011 by E-DA Hospital
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

September 1, 2010
November 22, 2012
November 2010
December 2013   (final data collection date for primary outcome measure)
Time to completely insertion [ Time Frame: 1 hour ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT01196962 on ClinicalTrials.gov Archive Site
rates of mechanical, infectious, and thrombotic complications [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Safety Study of Subclavian and Internal Jugular Venous Catheterization
A Randomize Controlled Trial to Compare the Complications of Subclavian and Internal Jugular Venous Catheterization in Critically Ill Patients

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
  • Time to Insertion
  • Rates of Complications
Device: Central venous catheter
Central venous catheter insertion to subclavian vein
Other Name: venous access
Experimental: Internal jugular vein
Intervention: Device: Central venous catheter
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
300
December 2013
December 2013   (final data collection date for primary outcome measure)

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
Both
20 Years and older
No
Contact: Yu-Feng Wei, M.D. +886-7-615-0011 ext 2980 ed102746@edah.org.tw
Taiwan
 
NCT01196962
CSIS, EDAH
Yes
E-DA Hospital
E-DA Hospital
Not Provided
Principal Investigator: Yu-Feng Wei, M.D. Chest department
E-DA Hospital
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP