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

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ClinicalTrials.gov Identifier: NCT01026649
Recruitment Status : Completed
First Posted : December 4, 2009
Last Update Posted : April 20, 2016
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
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 or disease Intervention/treatment
Hematoma Procedure: Central venous catheterization

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 334 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Study Start Date : November 2009
Primary Completion Date : May 2012
Study Completion Date : May 2012
Arms and Interventions

Arm Intervention/treatment
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


Outcome Measures

Primary Outcome Measures :
  1. hematoma formation [ Time Frame: immediately after catheterization ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Posted: December 4, 2009    Key Record Dates
Last Update Posted: April 20, 2016
Last Verified: April 2016

Keywords provided by Jae-Hyon Bahk, MD, PhD, Seoul National University Hospital:
hematoma formation
success rate

Additional relevant MeSH terms:
Hematoma
Hemorrhage
Pathologic Processes