Central Line Catheterization With Flexible Tip Straight Guidewire in Small Children

Catheterization, Central Venous Clinical Trial

Official title:

Central Line Insertion Technique in Small Infants Using Flexible Tip Straight Guidewire and J-tip Guidewire: a Randomized Controlled Trials

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03530618
• Other study ID #: H-1803-150-935
• Status: Completed
• Phase: N/A
• Start date: September 6, 2018
• Est. completion date: July 1, 2021

Study information

• Verified date: September 2021
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• 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 the flexible tip straight guidewire and J-tip guidewire for ultrasound-guided central venous catheterization in small children.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 1, 2021
• Est. primary completion date: July 1, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 6 Months

Eligibility

Inclusion Criteria:

• surgery under general anesthesia

• require central venous catheterization

Exclusion Criteria:

• central vein anomaly

• hematoma in central vein

• catheterization site infection

Related Conditions & MeSH terms

• Catheterization, Central Venous

Intervention

Device:
• Flexible tip straight guidewire
Use a flexible tip straight guidewire for ultrasound-guided central venous catheterization
• J-tip
Use a J tip straight guidewire for ultrasound-guided central venous catheterization

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	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	Time to first puncture of central vein		Interval between skin penetration of the needle and flashback of blood, an expected average of 30 seconds
Secondary	Time to guide wire insertion		Interval between skin penetration and removal of the needle after guide wire insertion, an expected average of 90 seconds
Secondary	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
Secondary	Number of central vein puncture trial		up to 5 times, an expected average observation time of 30 seconds
Secondary	Number of guide wire insertion trial		up to 5 times, an expected average observation time of 90 seconds
Secondary	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
Secondary	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