Comparison of the Central Venous Catheter Insertion Techniques

NCT02312388 | Completed

• 1 other identifier: H-1303-113-478
• Study Type: interventional
• Target: 138
• Locations: 1 country
• Sites: 1

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.

Conditions

Child; Surgery

Keywords

central venous catheters

Outcome Measures

Primary Outcomes (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 Outcomes (4)

• 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

Study Arms (2)

Catheter-over-the-needle technique

EXPERIMENTAL

to use the 22G angiocatheter for central venous catheterization

Other: catheter-over-the-needle technique

Thin-wall needle technique

EXPERIMENTAL

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

Other: Thin-wall needle technique

Interventions

catheter-over-the-needle technique OTHER

using a 22 G Angiocath Plus™ catheter

Also known as: modified Seldinger technique

Catheter-over-the-needle technique

Thin-wall needle technique OTHER

using 18 - 21 G introducer needle

Also known as: Seldinger technique

Thin-wall needle technique

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• surgery under general anesthesia
• require central venous catheterization

You may not qualify if:

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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, South Korea

Location

Study Officials

• Jin-Tae Kim, MD. PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: November 27, 2014
• First Posted: December 9, 2014
• Study Start: July 1, 2013
• Primary Completion: February 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 9, 2014

Record last verified: 2014-12

Locations

KR (1)