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The 2-stage Approach for Reducing Posterior Wall Puncture During the Internal Jugular Vein Catheterization

This study is currently recruiting participants.
Verified November 2011 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Jae-Hyon Bahk, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01026649
First received: November 19, 2009
Last updated: November 10, 2011
Last verified: November 2011
History of Changes
  Purpose

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.


Condition Intervention
Hematoma
 Procedure: Central venous catheterization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • hematoma formation [ Time Frame: immediately after catheterization ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 334
Study Start Date: November 2009
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 2 stage
Approach the internal jugular vein in a 2 stage fashion during central venous catheterization
 Procedure: Central venous catheterization
Approach the internal jugular vein in a 2 stage fashion during central venous catheterization
Active Comparator: 1 stage
Approach the internal jugular vein in a traditional one stage fashion during central venous catheterization
 Procedure: Central venous catheterization
Approach the internal jugular vein in a traditional one stage fashion during central venous catheterization

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01026649

Contacts
Contact: Ho Geol Ryu, MD, PhD 82-17-259-9173 hogeol@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Jae Hyon Bahk, MD PhD     82-2-2072-2818     bahkjh@snu.ac.kr    
Sponsors and Collaborators
Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Jae-Hyon Bahk, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01026649     History of Changes
Other Study ID Numbers: JHBahk_CVC two stage
Study First Received: November 19, 2009
Last Updated: November 10, 2011
Health Authority: Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
hematoma formation
success rate

Additional relevant MeSH terms:
Hematoma
Hemorrhage
Pathologic Processes

ClinicalTrials.gov processed this record on May 23, 2013