Influence of the Shoulder Position on the Catheter Tip Location During Infraclavicular Subclavian Approach

This study has been completed.
Sponsor:
Information provided by:
Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01024881
First received: December 2, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted
  Purpose

Infraclavicular approach of the subclavian veins is commonly used for central venous access. Aberrant locations of catheter tip are frequently quoted for this approach, but few studies have been performed to document the relationship between the shoulder position and catheter tip location. This prospective study was performed to assess the influence of the shoulder position on the safe and proper placement of infraclavicular subclavian catheters.


Condition Intervention
Catheter Tip Location
Procedure: neutral shoulder position
Procedure: lowered shoulder position

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:
  • location of the catheter tip [ Time Frame: at the end of surgery ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • catheterization success rate [ Time Frame: immediately after catheterization ] [ Designated as safety issue: No ]

Enrollment: 344
Study Start Date: December 2008
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: group 1
neutral shoulder position during infraclavicular subclavian catheterization
Procedure: neutral shoulder position
neutral shoulder position during infraclavicular subclavian catheterization
Experimental: group 2
lowered shoulder position during infraclavicular subclavian catheterization
Procedure: lowered shoulder position
lowered shoulder position during infraclavicular subclavian catheterization

  Eligibility

Ages Eligible for Study:   19 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • adult patients requiring central venous catheterization due to major procedures such as neurosurgery or thoracic surgery.

Exclusion Criteria:

  • chest deformities,
  • coagulopathy,
  • diaphragmatic dysfunction,
  • pulmonary malformation,
  • history of prior clavicle fracture, or
  • infection over the puncture site.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01024881

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

No publications provided

Responsible Party: Jae-Hyon Bahk, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01024881     History of Changes
Other Study ID Numbers: JHBahk_CVC shoulder position
Study First Received: December 2, 2009
Last Updated: December 2, 2009
Health Authority: South Korea: Institutional Review Board

Keywords provided by Seoul National University Hospital:
catheterization success rate

ClinicalTrials.gov processed this record on July 20, 2014