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NCT03530618 Clinical Trial

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
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design

Related Conditions & MeSH terms

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
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