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Central Venous Catheterization Techniques in Neonates

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02688595
Enrollment
120
Registered
2016-02-23
Start date
2016-03-31
Completion date
2017-09-30
Last updated
2018-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Catheterization, Central Venous

Keywords

Infant, Newborn, Ultrasonography

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.

Interventions

DEVICEUltrasound

Ultrasound-guided central venous catheterization in internal jugular vein

OTHERGeneral anesthesia

Scheduled operation under general anesthesia

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
1 Days to 1 Months
Healthy volunteers
No

Inclusion criteria

* surgery under general anesthesia * require central venous catheterization

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
First successful central venous catheterization rateInterval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes

Secondary

MeasureTime frame
Time to guide wire insertionInterval 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 catheterizationInterval 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 trialup to 5 times, an expected average observation time of 30 seconds
Time to first puncture of central veinInterval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds
First successful central vein puncture rateInterval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds
First successful guide wire insertion rateInterval between skin penetration and removal of the needle or angiocatheter after guide wire insertion, an expected average of 90 seconds
Number of guide wire insertion trialup to 5 times, an expected average observation time of 90 seconds

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 5, 2026