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

Primary Purpose

Catheter Complications, Critical Illness

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Long-axis syringe free in-plane
Short-axis out-of-plane
Sponsored by
Ataturk University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Catheter Complications focused on measuring ultrasound, catheter, long axis, short axis, pediatrics, syringe free

Eligibility Criteria

3 Months - 15 Years (Child)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Ataturk University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

syringe free long axis in-plane

Short axis out-of-plane

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Complications
Catheter related complications
Number of neddle pass
a change in needle direction without pulling the entire needle out of the skin
First pass success
Successful catheterization with only one needle pass.
New puncture
Withdraw the needle from the skin to change the puncture site

Full Information

First Posted
December 21, 2020
Last Updated
December 24, 2020
Sponsor
Ataturk University
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1. Study Identification

Unique Protocol Identification Number
NCT04684069
Brief Title
"Syringe Free" Long-Axis In-Plane vs. Short-Axis Out-of-Plane Approach for Central Venous Catheter Placement
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
Study Type
Interventional

2. Study Status

Record Verification Date
December 2020
Overall Recruitment Status
Completed
Study Start Date
July 1, 2020 (Actual)
Primary Completion Date
November 30, 2020 (Actual)
Study Completion Date
December 15, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ataturk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter Complications, Critical Illness
Keywords
ultrasound, catheter, long axis, short axis, pediatrics, syringe free

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
syringe free long axis in-plane
Arm Type
Active Comparator
Arm Title
Short axis out-of-plane
Arm Type
Sham Comparator
Intervention Type
Device
Intervention Name(s)
Long-axis syringe free in-plane
Intervention Description
Long-axis syringe-free in-plane catheter placement
Intervention Type
Device
Intervention Name(s)
Short-axis out-of-plane
Intervention Description
Short-axis out-of-plane catheter placement
Primary Outcome Measure Information:
Title
Performing time
Description
The time between the insertion of the needle through the skin and insertion of the guidewire into the internal jugular vein.
Time Frame
First 10 minutes
Secondary Outcome Measure Information:
Title
Complications
Description
Catheter related complications
Time Frame
First 24 hours
Title
Number of neddle pass
Description
a change in needle direction without pulling the entire needle out of the skin
Time Frame
First 10 minutes
Title
First pass success
Description
Successful catheterization with only one needle pass.
Time Frame
First 10 minutes
Title
New puncture
Description
Withdraw the needle from the skin to change the puncture site
Time Frame
First 10 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Months
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Ataturk University
City
Erzurum
ZIP/Postal Code
25100
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32174238
Citation
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.
Results Reference
background
PubMed Identifier
27650385
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.
Results Reference
background

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

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