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

Critical Illness Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04684069
• Other study ID #: AtaturkCatheter
• Status: Completed
• Phase: N/A
• Start date: July 1, 2020
• Est. completion date: December 15, 2020

Study information

• Verified date: December 2020
• Source: Ataturk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: December 15, 2020
• Est. primary completion date: November 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 15 Years

Eligibility

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

Related Conditions & MeSH terms

• Catheter Complications
• Critical Illness

Intervention

Device:
• Long-axis syringe free in-plane
Long-axis syringe-free in-plane catheter placement
• Short-axis out-of-plane
Short-axis out-of-plane catheter placement

Locations

Country	Name	City	State
Turkey	Ataturk University	Erzurum

Sponsors (1)

Lead Sponsor	Collaborator
Ataturk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

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