"Syringe Free" Long-Axis In-Plane vs. Short-Axis Out-of-Plane Approach for Central Venous Catheter Placement

"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

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.

Study Overview

• Status: Completed
• Conditions: Critical Illness; Catheter Complications
• Intervention / Treatment: Device: Long-axis syringe free in-plane; Device: Short-axis out-of-plane

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Erzurum, Turkey, 25100
    • Ataturk University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months to 15 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: syringe free long axis in-plane	Device: Long-axis syringe free in-plane; Long-axis syringe-free in-plane catheter placement
Sham Comparator: Short axis out-of-plane	Device: Short-axis out-of-plane; Short-axis out-of-plane catheter placement

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Performing time	The time between the insertion of the needle through the skin and insertion of the guidewire into the internal jugular vein.	First 10 minutes

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complications	Catheter related complications	First 24 hours
Number of neddle pass	a change in needle direction without pulling the entire needle out of the skin	First 10 minutes
First pass success	Successful catheterization with only one needle pass.	First 10 minutes
New puncture	Withdraw the needle from the skin to change the puncture site	First 10 minutes

Collaborators and Investigators

• Sponsor: Ataturk University

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 1, 2020
• Primary Completion (Actual): November 30, 2020
• Study Completion (Actual): December 15, 2020

Study Registration Dates

• First Submitted: December 21, 2020
• First Submitted That Met QC Criteria: December 21, 2020
• First Posted (Actual): December 24, 2020

Study Record Updates

• Last Update Posted (Actual): December 28, 2020
• Last Update Submitted That Met QC Criteria: December 24, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Keywords: pediatrics; ultrasound; catheter; short axis; long axis; syringe free
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Critical Illness
• Other Study ID Numbers: AtaturkCatheter

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No