Comparison of the Central Venous Catheter Insertion Techniques

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

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.

Study Overview

• Status: Completed
• Conditions: Child; Surgery
• Intervention / Treatment: Other: catheter-over-the-needle technique; Other: Thin-wall needle technique

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 Type: Interventional
• Enrollment (Actual): 138
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of
    • Seoul National University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• surgery under general anesthesia
• require central venous catheterization

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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

Outcome Measure	Time Frame
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Actual): February 1, 2014
• Study Completion (Actual): May 1, 2014

Study Registration Dates

• First Submitted: November 27, 2014
• First Submitted That Met QC Criteria: December 8, 2014
• First Posted (Estimate): December 9, 2014

Study Record Updates

• Last Update Posted (Estimate): December 9, 2014
• Last Update Submitted That Met QC Criteria: December 8, 2014
• Last Verified: December 1, 2014

More Information

Terms related to this study

• Keywords: central venous catheters
• Other Study ID Numbers: H-1303-113-478