Randomized Controlled Trial on Central Venous Catheterization Techniques in Neonates: Seldinger Versus Modified Seldinger

Seoul National University Hospital1 site in 1 country120 target enrollmentMarch 2016

ConditionsCatheterization, Central Venous

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Catheterization, Central Venous
Sponsor: Seoul National University Hospital
Enrollment: 120
Locations: 1
Primary Endpoint: First successful central venous catheterization rate
Status: Completed
Last Updated: 8 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of this study is to compare the differences in central venous catheter insertion time, success rate, and complication between the Seldinger and modified Seldinger technique for ultrasound-guided central venous catheterization in neonates.

Registry

clinicaltrials.gov

Start Date

March 2016

End Date

September 2017

Last Updated

8 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Seoul National University Hospital

Responsible Party

Principal Investigator

Jin-Tae Kim

Associate professor

Seoul National University Hospital

Eligibility Criteria

Inclusion Criteria

•surgery under general anesthesia
•require central venous catheterization

Exclusion Criteria

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

Outcomes

Primary Outcomes

First successful central venous catheterization rate

Time Frame: Interval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes

Secondary Outcomes

First successful guide wire insertion rate(Interval between skin penetration and removal of the needle or angiocatheter after guide wire insertion, an expected average of 90 seconds)
Time to guide wire insertion(Interval between skin penetration and removal of the needle or angiocatheter after guide wire insertion, an expected average of 90 seconds)
Total time to central venous catheterization(Interval between skin penetration of the needle or angiocatheter 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)
Time to first puncture of central vein(Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 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)