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
  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 September 22, 2014