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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2011 by Seoul National University Hospital.
Recruitment status was  Recruiting
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
  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 April 20, 2014