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Comparison of the Central Venous Catheter Insertion Techniques

Sponsor
Seoul National University Hospital (Other)
Overall Status
Completed
CT.gov ID
NCT02312388
Collaborator
(none)
138
Enrollment
1
Location
2
Arms
10
Duration (Months)
13.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to compare the differences in central venous catheter insertion time, success rate, and complication between thin-wall needle technique and catheter-over-the-needle technique for central venous catheterization in children.

Condition or Disease Intervention/Treatment Phase
  • Other: catheter-over-the-needle technique
  • Other: Thin-wall needle technique
 N/A

Detailed Description

Catheterization was performed using ultrasound with an "out-of-plane" approach by inserting the introducer needle (thin-wall needle technique) or Angiocath Plus™ catheter (catheter-over-the-needle technique) in 45 - 60° to the patient's skin while viewing the vein in a cross section.

Study Design

Study Type:
Interventional
Actual Enrollment :
138 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Supportive Care
Official Title:
Comparison of the Central Venous Catheter Insertion Techniques: the Thin-wall Needle Versus the Catheter-over-the-needle Technique in Children
Study Start Date :
Jul 1, 2013
Actual Primary Completion Date :
Feb 1, 2014
Actual Study Completion Date :
May 1, 2014

Arms and Interventions

Arm Intervention/Treatment
Experimental: Catheter-over-the-needle technique

to use the 22G angiocatheter for central venous catheterization

Other: catheter-over-the-needle technique
using a 22 G Angiocath Plus™ catheter
Other Names:
  • modified Seldinger technique

    		•
    Experimental: Thin-wall needle technique

    to use the sharp hollow 23G needle for central venous catheterization

    Other: Thin-wall needle technique
    using 18 - 21 G introducer needle
    Other Names:
  • Seldinger technique

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Guide-wire insertion time [interval between skin penetration and removal of the needle or catheter after guide wire insertion, an expected average of 80 seconds]

    Secondary Outcome Measures

    1. Time to first puncture of central vein [interval between skin penetration of the needle or catheter and flashback of blood, an expected average of 25 seconds]

    2. Total time of central venous catheter insertion [interval between skin penetration of the needle or catheter and installation of the indwelling catheter, an expected average of 3 minutes]

    3. Number of central vein puncture trial [up to 5 times, an expected average observation time of 25 seconds]

    4. Number of guide-wire insertion trial [up to 5 times, an expected average observation time of 80 seconds]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 5 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • surgery under general anesthesia

    • require central venous catheterization

    Exclusion Criteria:

    • hematoma in central vein

    • central vein anomaly

    • catheterization site infection

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Seoul National University Hospital Seoul Korea, Republic of

    Sponsors and Collaborators

    • Seoul National University Hospital

    Investigators

    • Principal Investigator: Jin-Tae Kim, MD. PhD, Seoul National University Hospital

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Jin-Tae Kim, Assistant professor, Seoul National University Hospital
    ClinicalTrials.gov Identifier:
    NCT02312388
    Other Study ID Numbers:
    • H-1303-113-478
    First Posted:
    Dec 9, 2014
    Last Update Posted:
    Dec 9, 2014
    Last Verified:
    Dec 1, 2014
    Keywords provided by Jin-Tae Kim, Assistant professor, Seoul National University Hospital
    central venous catheters

    Study Results

    No Results Posted as of Dec 9, 2014