Back to resultsThe 2-stage Approach for Reducing Posterior Wall Puncture During the Internal Jugular Vein Catheterization
Primary Purpose
Hematoma
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Central venous catheterization
Central venous catheterization
Sponsored by
About this trial
This is an interventional prevention trial for Hematoma focused on measuring hematoma formation, success rate
Eligibility Criteria
Inclusion Criteria:
- Patients who require a central venous catheter for their thoracic surgery
Exclusion Criteria:
- Refuse to enroll
- Infection at insertion site
- Carotid artery disease
- Anomaly of central vasculature
- Hypertrophied thyroid
- History of recent neck surgery
Sites / Locations
- Seoul National University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
2 stage
1 stage
Arm Description
Approach the internal jugular vein in a 2 stage fashion during central venous catheterization
Approach the internal jugular vein in a traditional one stage fashion during central venous catheterization
Outcomes
Primary Outcome Measures
hematoma formation
Secondary Outcome Measures
Full Information
NCT ID
NCT01026649
First Posted
November 19, 2009
Last Updated
April 19, 2016
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01026649
Brief Title
The 2-stage Approach for Reducing Posterior Wall Puncture During the Internal Jugular Vein Catheterization
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
November 2009 (undefined)
Primary Completion Date
May 2012 (Actual)
Study Completion Date
May 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the effect of a 2-stage approach to the internal jugular vein when performing a central venous catheterization compared to the traditional one stage approach on the incidence of hematoma formation and success rate.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematoma
Keywords
hematoma formation, success rate
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
334 (Actual)
8. Arms, Groups, and Interventions
Arm Title
2 stage
Arm Type
Experimental
Arm Description
Approach the internal jugular vein in a 2 stage fashion during central venous catheterization
Arm Title
1 stage
Arm Type
Active Comparator
Arm Description
Approach the internal jugular vein in a traditional one stage fashion during central venous catheterization
Intervention Type
Procedure
Intervention Name(s)
Central venous catheterization
Intervention Description
Approach the internal jugular vein in a traditional one stage fashion during central venous catheterization
Intervention Type
Procedure
Intervention Name(s)
Central venous catheterization
Intervention Description
Approach the internal jugular vein in a 2 stage fashion during central venous catheterization
Primary Outcome Measure Information:
Title
hematoma formation
Time Frame
immediately after catheterization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients who require a central venous catheter for their thoracic surgery
Exclusion Criteria:
Refuse to enroll
Infection at insertion site
Carotid artery disease
Anomaly of central vasculature
Hypertrophied thyroid
History of recent neck surgery
Facility Information:
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
The 2-stage Approach for Reducing Posterior Wall Puncture During the Internal Jugular Vein Catheterization
We'll reach out to this number within 24 hrs