Comparison of the Central Venous Catheter Insertion Techniques

Not Applicable

Completed

• Conditions: Child; Surgery
• Interventions: Other: catheter-over-the-needle technique; Other: Thin-wall needle technique

• Registration Number: NCT02312388
• Lead Sponsor: Seoul National University Hospital

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 Timeline

• Study Start: 2013-07
• Primary Completion: 2014-02
• Study Completion: 2014-05
• Study First Submitted: 2014-11-27
• Status Verified: 2014-12
• Study First Submitted QC: 2014-12-08
• Last Update Submitted: 2014-12-08
• Study First Posted: 2014-12-09
• Last Update Posted: 2014-12-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 138

Inclusion Criteria

• surgery under general anesthesia
• require central venous catheterization

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Exclusion Criteria

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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter-over-the-needle technique	catheter-over-the-needle technique	to use the 22G angiocatheter for central venous catheterization
Thin-wall needle technique	Thin-wall needle technique	to use the sharp hollow 23G needle for central venous catheterization

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of