Ultrasound-guided Subclavian Venous Catheterization in Children (SuCVC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jin-Tae Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01527175
First received: January 28, 2012
Last updated: March 30, 2012
Last verified: March 2012
  Purpose

The subclavian vein (SCV) is often the preferred site for central venous access. Ultrasound-guided SCV catheterizations with supraclavicular (SC) or infraclavicular (IC) approach have been proved to be useful in children. The investigators compared the success rate, number of attempts, time tocatheterization, and complication.


Condition Intervention
Subclavian Venous Catheterization in Children
Other: Approach for ultrasound-guided subclavian venous catheterization

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Comparision of Ultrasound-guided Supraclavicular and Infraclavicular Approach for Central Venous Catheterization in Children

Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • The duration for susscessful placement of needle into subclavian vein [ Time Frame: within 20 minutes ] [ Designated as safety issue: Yes ]
    The time needed to place needle into the vein (from needle entry into the skin to aspiration of blood with syringe) was measured. When the duration was recorded as greater than 20 min, the procedure was defined unsuccessful and excluded from the analysis.


Secondary Outcome Measures:
  • The number of attempt for susscessful placement of needle into subclavian vein. [ Time Frame: within 20 minutes ] [ Designated as safety issue: Yes ]
    An 'attempt' was defined as each needle advancement to place needl into the vein. When the duration for susscessful placement of needle into subclavian vein was recorded as greater than 20 min, the procedure was defined unsuccessful and excluded from the analysis.


Enrollment: 98
Study Start Date: November 2011
Primary Completion Date: February 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: supraclavicular
supraclavicular: supraclavicular approach for subclavian venous catheterization
Other: Approach for ultrasound-guided subclavian venous catheterization
Each SCV catheterization was performed under ultrasound-guidance with supraclvicular or infraclavicular approach.
Placebo Comparator: infraclavicular
infraclavicular: infraclavicular approach for subclavian venous catheterization
Other: Approach for ultrasound-guided subclavian venous catheterization
Each SCV catheterization was performed under ultrasound-guidance with supraclvicular or infraclavicular approach.

  Eligibility

Ages Eligible for Study:   up to 10 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • central venous lines required patients
  • children < 10 yr of age

Exclusion Criteria:

  • inadequate ultrasound visualization of the subclavian vein
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01527175

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 by Seoul National University Hospital

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Jin-Tae Kim, assistant professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01527175     History of Changes
Other Study ID Numbers: JNB-KJT-12
Study First Received: January 28, 2012
Last Updated: March 30, 2012
Health Authority: Korea: Food and Drug Administration

ClinicalTrials.gov processed this record on April 17, 2014