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Clinical Trials/NCT02312388
NCT02312388CompletedNot Applicable

Comparison of the Central Venous Catheter Insertion Techniques: the Thin-wall Needle Versus the Catheter-over-the-needle Technique in Children

Seoul National University Hospital1 site in 1 country138 target enrollmentStarted: July 1, 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
138
Locations
1
Primary Endpoint
Guide-wire insertion time

Study Overview

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.

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
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
— to 5 Years (Child)
Sex
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

Arms & Interventions

Catheter-over-the-needle technique

Experimental

to use the 22G angiocatheter for central venous catheterization

Intervention: catheter-over-the-needle technique (Other)

Thin-wall needle technique

Experimental

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

Intervention: Thin-wall needle technique (Other)

Outcomes

Primary Outcomes

Guide-wire insertion time

Time Frame: interval between skin penetration and removal of the needle or catheter after guide wire insertion, an expected average of 80 seconds

Secondary Outcomes

  • 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)
  • 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)
  • Number of central vein puncture trial(up to 5 times, an expected average observation time of 25 seconds)
  • Number of guide-wire insertion trial(up to 5 times, an expected average observation time of 80 seconds)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jin-Tae Kim

Assistant professor

Seoul National University Hospital

Study Sites (1)

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