Clinical trial NCT04684069: "Syringe Free" Long-Axis In-Plane vs. Short-Axis Out-of-Plane Approach for Central Venous Catheter Placement
Official title: "Syringe Free" Long-Axis In-Plane vs. Short-Axis Out-of-Plane Approach for Ultrasound-Guided Central Venous Catheter Placement in Critically Ill Children: A Prospective Randomized Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Catheter Complications
Critical Illness
Keywords: ultrasound
catheter
long axis
short axis
pediatrics
syringe free
Lead sponsor: Ataturk University
Sponsor class: OTHER
First posted: 2020-12-24
Enrollment: 60
Sex: ALL
Minimum age (years): 3
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Internal jugular, subclavian, or femoral veins are often used for central venous catheter (CVC) placement. Regardless of which vein is preferred, the "Seldinger" technique is used most frequently. The most commonly used method with ultrasound is the short-axis out-of-plane approach. The main problem in this method is that the correct needle tip is missed, and it causes some complications by causing posterior wall punctures. The "Syringe-free" technique is first reported by Matias et al. in adults; it is a technique that allows full real-time monitoring of the guidewire insertion into the vein without blood aspiration. It is a great advantage in CVC placement, especially with the long-axis in-plane approach. When the literature is reviewed, no study other than a 12 case study in which brachiocephalic vein catheterization related to CVC placement was performed using this technique in children was found. There is no randomized study comparing the "Syringe-free" Long-Axis In-Plane technique with the classic Short-Axis Out-of-Plane technique in pediatric patients.

This study compares these two techniques' efficacy and complication rates in critically ill children requiring CVC placement.


Eligibility criteria: Inclusion Criteria:

* Patients older than 3 months, younger than 15 years old
* Critical illness pediatrics

Exclusion Criteria:

* Patients younger than 3 months and older than 15 years,
* body weight less than 5000 gr,
* anatomical malformation in the neck,
* infection at the intervention site,
* thrombosis

Primary outcomes:
measure: Performing time
timeFrame: First 10 minutes
Secondary outcomes:
measure: Complications
timeFrame: First 24 hours
measure: Number of neddle pass
timeFrame: First 10 minutes
measure: First pass success
timeFrame: First 10 minutes
measure: New puncture
timeFrame: First 10 minutes
Other outcomes:
Locations:
city: Erzurum
country: Turkey
facility: Ataturk University
Study officials:
References:
citation: Balaban O, Turgut M, Aydin T. Ultrasound-guided supraclavicular brachiocephalic vein catheterization in children: Syringe-free in-plane technique with micro-convex probe. J Vasc Access. 2020 Mar;21(2):241-245. doi: 10.1177/1129729819867221. Epub 2019 Sep 6.
citation: Matias F, Semedo E, Carreira C, Pereira P. [Ultrasound-guided central venous catheterization - "Syringe-Free" approach]. Rev Bras Anestesiol. 2017 May-Jun;67(3):314-317. doi: 10.1016/j.bjan.2016.08.005. Epub 2016 Sep 17. Portuguese.