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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Catheter Complications, Critical Illness

Intervention / Treatment
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* Device: Long-axis syringe free in-plane
* Device: Short-axis out-of-plane


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 3 Months
Maximum Age: 15 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ultrasound, catheter, long axis, short axis, pediatrics, syringe free