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

NCT ID: NCT04684069

Last Updated: 2020-12-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-07-01
• Study Completion Date: 2020-12-15

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

syringe free long axis in-plane

Group Type: ACTIVE_COMPARATOR

Long-axis syringe free in-plane

Intervention Type: DEVICE

Long-axis syringe-free in-plane catheter placement

Short axis out-of-plane

Group Type: SHAM_COMPARATOR

Short-axis out-of-plane

Intervention Type: DEVICE

Short-axis out-of-plane catheter placement

Interventions

Long-axis syringe free in-plane

Long-axis syringe-free in-plane catheter placement

Intervention Type: DEVICE

Short-axis out-of-plane

Short-axis out-of-plane catheter placement

Intervention Type: DEVICE

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

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ataturk University

OTHER

Sponsor Role: lead

Responsible Party

Ali Ahiskalioglu

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Ataturk University

Erzurum, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

References

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.

Reference Type: BACKGROUND

PMID: 32174238 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 27650385 (View on PubMed)

Other Identifiers

AtaturkCatheter

Identifier Type: -

Identifier Source: org_study_id