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Safety Study of Subclavian and Internal Jugular Venous Catheterization

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ClinicalTrials.gov Identifier: NCT01196962
Recruitment Status : Unknown
Verified August 2011 by E-DA Hospital.
Recruitment status was:  Recruiting
First Posted : September 9, 2010
Last Update Posted : November 27, 2012
Sponsor:
Information provided by (Responsible Party):
E-DA Hospital

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Time to Insertion Rates of Complications Device: Central venous catheter Not Applicable

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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
Study Start Date : November 2010
Estimated Primary Completion Date : December 2013
Estimated Study Completion Date : December 2013
Arms and Interventions
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Arm Intervention/treatment
Experimental: Internal jugular vein Device: Central venous catheter
Central venous catheter insertion to subclavian vein
Other Name: venous access


Outcome Measures
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Primary Outcome Measures :
  1. Time to completely insertion [ Time Frame: 1 hour ]

Secondary Outcome Measures :
  1. rates of mechanical, infectious, and thrombotic complications [ Time Frame: 14 days ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Responsible Party: E-DA Hospital
ClinicalTrials.gov Identifier: NCT01196962     History of Changes
Other Study ID Numbers: CSIS
EDAH ( Other Identifier: EDAH )
First Posted: September 9, 2010    Key Record Dates
Last Update Posted: November 27, 2012
Last Verified: August 2011

Keywords provided by E-DA Hospital:
central venous catheter
complications
internal jugular vein
randomized trial
subclavian vein