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

Hematoma Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01026649
• Other study ID #: JHBahk_CVC two stage
• Status: Completed
• Phase: N/A
• First received: November 19, 2009
• Last updated: April 19, 2016
• Start date: November 2009
• Est. completion date: May 2012

Study information

• Verified date: April 2016
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 334
• Est. completion date: May 2012
• Est. primary completion date: May 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years to 80 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Hematoma

Intervention

Procedure:
• Central venous catheterization
Approach the internal jugular vein in a traditional one stage fashion during central venous catheterization
• Central venous catheterization
Approach the internal jugular vein in a 2 stage fashion during central venous catheterization

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	hematoma formation		immediately after catheterization	Yes