Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT03530618
NCT03530618CompletedNot Applicable

Central Line Insertion Technique in Small Infants Using Flexible Tip Straight Guidewire and J-tip Guidewire: a Randomized Controlled Trials

Seoul National University Hospital1 site in 1 country88 target enrollmentStarted: September 6, 2018Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
88
Locations
1
Primary Endpoint
First successful central venous catheterization rate
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

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 the flexible tip straight guidewire and J-tip guidewire for ultrasound-guided central venous catheterization in small children.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
— to 6 Months (Child)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •surgery under general anesthesia
  • •require central venous catheterization

Exclusion Criteria

  • •central vein anomaly
  • •hematoma in central vein
  • •catheterization site infection

Arms & Interventions

Flexible tip straight guidewire

Experimental

Intervention: Flexible tip straight guidewire (Device)

J-tip guidewire

Experimental

Intervention: J-tip (Device)

Outcomes

Primary Outcomes

First successful central venous catheterization rate

Time Frame: Interval between skin penetration of the needle and installation of the indwelling catheter, an expected average of 3 minutes

Secondary Outcomes

  • Time to first puncture of central vein(Interval between skin penetration of the needle and flashback of blood, an expected average of 30 seconds)
  • Time to guide wire insertion(Interval between skin penetration and removal of the needle after guide wire insertion, an expected average of 90 seconds)
  • Total time to central venous catheterization(Interval between skin penetration of the needle 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 30 seconds)
  • Number of guide wire insertion trial(up to 5 times, an expected average observation time of 90 seconds)
  • First successful central vein puncture rate(Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds)
  • First successful guide wire insertion rate(Interval between skin penetration and removal of the needle after guide wire insertion, an expected average of 90 seconds)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Jin-Tae Kim

professor

Seoul National University Hospital

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Comparison of the Central Venous Catheter Insertion TechniquesChildSurgery
NCT02312388Seoul National University Hospital138
Completed
Not Applicable
Central Venous Catheterization Techniques in NeonatesCatheterization, Central Venous
NCT02688595Seoul National University Hospital120
Completed
Not Applicable
Less Pain in Neonates During Central Lines InsertionNeonatesPainCentral Venous Catheter
NCT03647293Saint George Hospital61
Completed
Not Applicable
Medium-term Venous Access in Congenital Heart SurgeryCongenital Heart Surgery
NCT00852488Vanderbilt University Medical Center50
Not yet recruiting
Not Applicable
Evaluation of the new guideline for diagnosis and treatment catheter-related thrombosis in neonates on the neonatal intensive care unitCatheter-related thrombosis in neonates
NL-OMON26109Academic Medical Center, Amsterdam100