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Ultrasound Guided Central Vein Catheterization and Complications

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Seoul National University Bundang Hospital
Sponsor:
Information provided by (Responsible Party):
Hyo-Seok Na, Seoul National University Bundang Hospital
ClinicalTrials.gov Identifier:
NCT01510743
First received: January 9, 2012
Last updated: May 21, 2014
Last verified: May 2014
  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 Seoul National University Bundang Hospital:

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


Secondary Outcome Measures:
  • Access time [ Time Frame: during central venous catheterization ] [ Designated as safety issue: No ]
    from penetration of skin to aspiration of venous blood into the syringe

  • Number of attempts [ Time Frame: during central venous catheterization ] [ Designated as safety issue: No ]
    once/twice/three times

  • catheter tip placement [ Time Frame: postoperative 1 day ] [ Designated as safety issue: No ]

    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 2014
Estimated Primary Completion Date: December 2014 (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

Ages Eligible for Study:   15 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: January 9, 2012
Last Updated: May 21, 2014
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Bundang Hospital:
open heart surgery
lung surgery
spine surgery
hepatobiliary surgery

ClinicalTrials.gov processed this record on November 20, 2014