Central Line Catheterization With Flexible Tip Straight Guidewire in Small Children

Not Applicable

Completed

• Conditions: Catheterization, Central Venous
• Interventions: Device: Flexible tip straight guidewire; Device: J-tip

• Registration Number: NCT03530618
• 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 the flexible tip straight guidewire and J-tip guidewire for ultrasound-guided central venous catheterization in small children.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-05-08
• Study First Submitted QC: 2018-05-08
• Study First Posted: 2018-05-21
• Study Start: 2018-09-06
• Primary Completion: 2021-07-01
• Study Completion: 2021-07-01
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-13
• Last Update Posted: 2021-09-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 88

Inclusion Criteria

• surgery under general anesthesia
• require central venous catheterization

Exclusion Criteria

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Flexible tip straight guidewire	Flexible tip straight guidewire	-
J-tip guidewire	J-tip	-

Primary Outcome Measures

Name	Time	Method
First successful central venous catheterization rate	Interval between skin penetration of the needle and installation of the indwelling catheter, an expected average of 3 minutes

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

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