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Ultrasound Guided Central Vein Catheterization and Complications

This study is currently recruiting participants.
Verified October 2016 by Hyo-Seok Na, Seoul National University Bundang Hospital
Sponsor:
ClinicalTrials.gov Identifier:
NCT01510743
First Posted: January 16, 2012
Last Update Posted: October 28, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital
  Purpose
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.

Condition
Brain Tumor

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Incidence of Complication Depending on the Cannulation Site in US Guided Central Vein Catheterization

Further study details as provided by Hyo-Seok Na, Seoul National University Bundang Hospital:

Primary Outcome Measures:
  • complication [ Time Frame: during central vein catheterization and operation day ]
    any one of arterial puncture, hematoma, pneumothorax, hemothorax


Secondary Outcome Measures:
  • Access time [ Time Frame: during central venous catheterization ]
    from penetration of skin to aspiration of venous blood into the syringe

  • Number of attempts [ Time Frame: during central venous catheterization ]
    once/twice/three times

  • 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



Estimated Enrollment: 1484
Study Start Date: January 2012
Estimated Study Completion Date: December 2017
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
Group SC
US guided subclavian vein catheterization
Group IJ
US-guided internal jugular vein catheterization

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   15 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing surgeries requiring central vein catheterizations for anesthetic management.
Criteria

Inclusion Criteria:

  • Patients undergoing surgeries requiring central vein catheterizations for anesthetic management.

Exclusion Criteria:

  • Refuse
  • hematologic disorder
  • Anatomical abnormalities of central vein structure
  Contacts and Locations
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): NCT01510743


Contacts
Contact: Hyo-Seok Na, Professor 82 31 787 7507 hsknana@gmail.com

Locations
Korea, Republic of
Seoul National University Bundang Hospital Recruiting
Seongnam, Gyounggi, Korea, Republic of, 463-707
Contact: Hyo-Seok Na, Professor    82-31-787-7507    hsknana@gmail.com   
Sub-Investigator: Hyo-Seok Na, Professor         
Sponsors and Collaborators
Seoul National University Bundang Hospital
Investigators
Study Director: Jin-Hee Kim, Professor Seoul National University Bundang Hospital
  More Information

Responsible Party: Hyo-Seok Na, Assistant professor, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier: NCT01510743     History of Changes
Other Study ID Numbers: B1112_069_003
First Submitted: January 9, 2012
First Posted: January 16, 2012
Last Update Posted: October 28, 2016
Last Verified: October 2016

Keywords provided by Hyo-Seok Na, Seoul National University Bundang Hospital:
open heart surgery
lung surgery
spine surgery
hepatobiliary surgery