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Ultrasound Guided Central Vein Catheterization and Complications

This study is ongoing, but not recruiting participants.
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: January 26, 2012
Last verified: January 2012
History of Changes
  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

Resource links provided by NLM:

U.S. FDA Resources

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: January 2013
Estimated Primary Completion Date: January 2012 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01510743

Locations
Korea, Republic of
Seoul National University Bundang Hospital
Seongnam, Gyounggi, Korea, Republic of, 463-707
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: January 26, 2012
Health Authority: South Korea: Institutional Review Board

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

Additional relevant MeSH terms:
Brain Neoplasms
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
 Neoplasms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 19, 2013