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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01026649
First received: November 19, 2009
Last updated: April 19, 2016
Last verified: April 2016
  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 ]

Enrollment: 334
Study Start Date: November 2009
Study Completion Date: May 2012
Primary Completion Date: May 2012 (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   (Adult, Senior)
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
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: NCT01026649

Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
  More Information

Responsible Party: Jae-Hyon Bahk, MD, PhD, 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: April 19, 2016
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 September 30, 2016