- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01003366
Effect of the Bevel Direction of Puncture Needle on Success Rate and Complications During Central Venous Catheterization
March 18, 2011 updated by: Seoul National University Hospital
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.
Study Overview
Status
Completed
Conditions
Study Type
Interventional
Enrollment (Anticipated)
338
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Seoul, Korea, Republic of, 110-744
- Seoul National University Hospital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
19 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: bevel down
approaching the IJV with the needle bevel facing down
|
approaching the IJV with the needle bevel facing down
approaching the IJV with the needle bevel facing up
|
Active Comparator: bevel up
approaching the IJV with the needle bevel facing up
|
approaching the IJV with the needle bevel facing down
approaching the IJV with the needle bevel facing up
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
posterior wall puncture of internal jugular vein
Time Frame: immediately after catheterization
|
immediately after catheterization
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2009
Primary Completion (Actual)
January 1, 2011
Study Completion (Actual)
February 1, 2011
Study Registration Dates
First Submitted
October 27, 2009
First Submitted That Met QC Criteria
October 27, 2009
First Posted (Estimate)
October 28, 2009
Study Record Updates
Last Update Posted (Estimate)
March 22, 2011
Last Update Submitted That Met QC Criteria
March 18, 2011
Last Verified
March 1, 2011
More Information
Terms related to this study
Other Study ID Numbers
- JHBahk_CVC bevel
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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