Comparison of the Central Venous Catheter Insertion Techniques

Surgery Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02312388
• Other study ID #: H-1303-113-478
• Status: Completed
• Phase: N/A
• First received: November 27, 2014
• Last updated: December 8, 2014
• Start date: July 2013
• Est. completion date: May 2014

Study information

• Verified date: December 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 138
• Est. completion date: May 2014
• Est. primary completion date: February 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 5 Years

Eligibility

Inclusion Criteria:

• surgery under general anesthesia

• require central venous catheterization

Exclusion Criteria:

• hematoma in central vein

• central vein anomaly

• catheterization site infection

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Child
• Surgery

Intervention

Other:
• catheter-over-the-needle technique
using a 22 G Angiocath Plus™ catheter
• Thin-wall needle technique
using 18 - 21 G introducer needle

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	Number of central vein puncture trial		up to 5 times, an expected average observation time of 25 seconds	No
Secondary	Number of guide-wire insertion trial		up to 5 times, an expected average observation time of 80 seconds	No