Clinical trial NCT02688595: Central Venous Catheterization Techniques in Neonates
Official title: Randomized Controlled Trial on Central Venous Catheterization Techniques in Neonates: Seldinger Versus Modified Seldinger
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheterization, Central Venous
Keywords: Infant, Newborn
Ultrasonography
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2016-02-23
Enrollment: 120
Sex: ALL
Minimum age (years): 1
Maximum age (years): 1
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility criteria: Inclusion Criteria:

* surgery under general anesthesia
* require central venous catheterization

Exclusion Criteria:

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

Primary outcomes:
measure: First successful central venous catheterization rate
timeFrame: Interval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes
Secondary outcomes:
measure: Time to first puncture of central vein
timeFrame: Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds
measure: Time to guide wire insertion
timeFrame: Interval between skin penetration and removal of the needle or angiocatheter after guide wire insertion, an expected average of 90 seconds
measure: Total time to central venous catheterization
timeFrame: Interval between skin penetration of the needle or angiocatheter and installation of the indwelling catheter, an expected average of 3 minutes
measure: Number of central vein puncture trial
timeFrame: up to 5 times, an expected average observation time of 30 seconds
measure: Number of guide wire insertion trial
timeFrame: up to 5 times, an expected average observation time of 90 seconds
measure: First successful central vein puncture rate
timeFrame: Interval between skin penetration of the needle or angiocatheter and flashback of blood, an expected average of 30 seconds
measure: First successful guide wire insertion rate
timeFrame: Interval between skin penetration and removal of the needle or angiocatheter after guide wire insertion, an expected average of 90 seconds
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seoul National University Hospital
Study officials:
affiliation: Seoul National University Hospital
name: Jin-Tae Kim
role: PRINCIPAL_INVESTIGATOR
References:
citation: Grebenik CR, Boyce A, Sinclair ME, Evans RD, Mason DG, Martin B. NICE guidelines for central venous catheterization in children. Is the evidence base sufficient? Br J Anaesth. 2004 Jun;92(6):827-30. doi: 10.1093/bja/aeh134. Epub 2004 Apr 30.
citation: Song IK, Lee JH, Kang JE, Oh HW, Kim HS, Park HP, Kim JT. Comparison of central venous catheterization techniques in pediatric patients: needle vs angiocath. Paediatr Anaesth. 2015 Nov;25(11):1120-6. doi: 10.1111/pan.12726. Epub 2015 Aug 6.
citation: Song IK, Kim EH, Lee JH, Jang YE, Kim HS, Kim JT. Seldinger vs modified Seldinger techniques for ultrasound-guided central venous catheterisation in neonates: a randomised controlled trial. Br J Anaesth. 2018 Dec;121(6):1332-1337. doi: 10.1016/j.bja.2018.08.008. Epub 2018 Sep 7.