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OpenTrials
Completed

NCT Number: NCT04684069

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

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.

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Key information

Age range

3 month–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Ataturk University

Erzurum, 25100, Turkey (Türkiye)

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Long-axis syringe free in-plane

Device

Long-axis syringe-free in-plane catheter placement

Short-axis out-of-plane

Device

Short-axis out-of-plane catheter placement

Primary outcomes

  1. Performing time

    Time frame: First 10 minutes

    The time between the insertion of the needle through the skin and insertion of the guidewire into the internal jugular vein.

Secondary outcomes

  1. Complications

    Time frame: First 24 hours

    Catheter related complications

  2. Number of neddle pass

    Time frame: First 10 minutes

    a change in needle direction without pulling the entire needle out of the skin

  3. First pass success

    Time frame: First 10 minutes

    Successful catheterization with only one needle pass.

  4. New puncture

    Time frame: First 10 minutes

    Withdraw the needle from the skin to change the puncture site

Sponsors and collaborators

Lead sponsor

Ataturk University

Other

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Dec 24, 2020
Registry last updated
Dec 28, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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