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

NCT04684069 | Completed

• 1 other identifier: AtaturkCatheter
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Catheter Complications; Critical Illness

Keywords

ultrasound; catheter; long axis; short axis; pediatrics; syringe free

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Complications

  First 24 hours

• Number of neddle pass

  First 10 minutes

• First pass success

  First 10 minutes

• New puncture

  First 10 minutes

Study Arms (2)

syringe free long axis in-plane

ACTIVE COMPARATOR

Device: Long-axis syringe free in-plane

Short axis out-of-plane

SHAM COMPARATOR

Device: Short-axis out-of-plane

Interventions

Long-axis syringe free in-plane DEVICE

Long-axis syringe-free in-plane catheter placement

syringe free long axis in-plane

Short-axis out-of-plane DEVICE

Short-axis out-of-plane catheter placement

Short axis out-of-plane

Eligibility Criteria

• Age: 3 Months - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ataturk University: lead

Study Sites (1)

Ataturk University

Erzurum, 25100, Turkey (Türkiye)

Location

Related 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.

  PMID: 32174238 BACKGROUND

• 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.

  PMID: 27650385 BACKGROUND

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 21, 2020
• First Posted: December 24, 2020
• Study Start: July 1, 2020
• Primary Completion: November 30, 2020
• Study Completion: December 15, 2020
• Last Updated: December 28, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)