- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01510743
Ultrasound Guided Central Vein Catheterization and Complications
August 24, 2018 updated by: Hyo-Seok Na, Seoul National University Bundang Hospital
Incidence of Complication Depending on the Cannulation Site in US Guided Central Vein Catheterization
There has been no study comparing the complication rates between internal jugular vein catheterization and subclavian vein catheterization when they are performed using sonographic view.
This prospective study would reveal the sort of complication and its rate.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1484
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
-
-
Gyounggi
-
Seongnam, Gyounggi, Korea, Republic of, 463-707
- Seoul National University Bundang Hospital
-
-
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
15 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients undergoing surgeries requiring central vein catheterizations for anesthetic management.
Exclusion Criteria:
- Refuse
- hematologic disorder
- Anatomical abnormalities of central vein structure
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
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group SC
US guided subclavian vein catheterization
|
Catheterization of subclavian vein
|
|
Active Comparator: Group IJ
US-guided internal jugular vein catheterization
|
Catheterization of internal jugular vein
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
complication
Time Frame: during central vein catheterization and operation day
|
any one of arterial puncture, hematoma, pneumothorax, hemothorax
|
during central vein catheterization and operation day
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Access time
Time Frame: during central venous catheterization
|
from penetration of skin to aspiration of venous blood into the syringe
|
during central venous catheterization
|
|
Number of attempts
Time Frame: during central venous catheterization
|
once/twice/three times
|
during central venous catheterization
|
|
catheter tip placement
Time Frame: postoperative 1 day
|
After reviewing the postoperative chest X ray film, we will check the position of the central venous catheter tip. The possible pisition of catheter tip is as follows: (1) Superior vena cava and Rirht Atrium junction (2)Right internal jugular vein (3)Left Internal jugular vein (4)Right Axillary vein (5)Lt. Axillary vein |
postoperative 1 day
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Director: Jin-Hee Kim, Professor, Seoul National University Bundang Hospital
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 (Actual)
January 30, 2012
Primary Completion (Actual)
April 1, 2018
Study Completion (Actual)
April 1, 2018
Study Registration Dates
First Submitted
January 9, 2012
First Submitted That Met QC Criteria
January 13, 2012
First Posted (Estimate)
January 16, 2012
Study Record Updates
Last Update Posted (Actual)
August 27, 2018
Last Update Submitted That Met QC Criteria
August 24, 2018
Last Verified
August 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- B1112_069_003
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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