Effect of the Bevel Direction of Puncture Needle on Success Rate and Complications During Central Venous Catheterization

This study has been completed.

Sponsor:

Information provided by:

Seoul National University Hospital

ClinicalTrials.gov Identifier:

NCT01003366

First received: October 27, 2009

Last updated: March 18, 2011

Last verified: March 2011

History of Changes

Tracking Information
First Received Date ^ICMJE	October 27, 2009
Last Updated Date	March 18, 2011
Start Date ^ICMJE	March 2009
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 27, 2009)	posterior wall puncture of internal jugular vein [ Time Frame: immediately after catheterization ] [ Designated as safety issue: Yes ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01003366 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Effect of the Bevel Direction of Puncture Needle on Success Rate and Complications During Central Venous Catheterization
Official Title ^ICMJE	Not Provided
Brief Summary	To test the hypothesis that approaching the internal jugular vein with the needle bevel down would produce less injury to the vessel wall compared to the bevel up approach during central venous catheterization.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label
Condition ^ICMJE	Central Venous Catheterization
Intervention ^ICMJE	Device: bevel direction during central venous catheterization approaching the IJV with the needle bevel facing down Device: bevel direction during central venous catheterization approaching the IJV with the needle bevel facing up
Study Arm (s)	Experimental: bevel down approaching the IJV with the needle bevel facing down Intervention: Device: bevel direction during central venous catheterization Active Comparator: bevel up approaching the IJV with the needle bevel facing up Intervention: Device: bevel direction during central venous catheterization
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Estimated Enrollment ^ICMJE	338
Completion Date	February 2011
Primary Completion Date	January 2011 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: patients undergoing surgery that requires the placement of a central venous catheter at the internal jugular vein Exclusion Criteria: anatomical anomaly in the neck region recent history of central venous catheterization
Gender	Both
Ages	19 Years to 70 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Korea, Republic of

Administrative Information
NCT Number ^ICMJE	NCT01003366
Other Study ID Numbers ^ICMJE	JHBahk_CVC bevel
Has Data Monitoring Committee	No
Responsible Party	Jae-Hyon Bahk, Seoul National University Hospital
Study Sponsor ^ICMJE	Seoul National University Hospital
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Seoul National University Hospital
Verification Date	March 2011
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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