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

Sponsor
Ataturk University (Other)
Overall Status
Completed
CT.gov ID
NCT04684069
Collaborator
(none)
60
1
2
5.5
10.9

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Long-axis syringe free in-plane
  • Device: Short-axis out-of-plane
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Jul 1, 2020
Actual Primary Completion Date :
Nov 30, 2020
Actual Study Completion Date :
Dec 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: syringe free long axis in-plane

Device: Long-axis syringe free in-plane
Long-axis syringe-free in-plane catheter placement

Sham Comparator: Short axis out-of-plane

Device: Short-axis out-of-plane
Short-axis out-of-plane catheter placement

Outcome Measures

Primary Outcome Measures

  1. Performing time [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 Outcome Measures

  1. Complications [First 24 hours]

    Catheter related complications

  2. Number of neddle pass [First 10 minutes]

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

  3. First pass success [First 10 minutes]

    Successful catheterization with only one needle pass.

  4. New puncture [First 10 minutes]

    Withdraw the needle from the skin to change the puncture site

Eligibility Criteria

Criteria

Ages Eligible for Study:
3 Months to 15 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ataturk University Erzurum Turkey 25100

Sponsors and Collaborators

  • Ataturk University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Ali Ahiskalioglu, Principal Investigator, Ataturk University
ClinicalTrials.gov Identifier:
NCT04684069
Other Study ID Numbers:
  • AtaturkCatheter
First Posted:
Dec 24, 2020
Last Update Posted:
Dec 28, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Ali Ahiskalioglu, Principal Investigator, Ataturk University
Additional relevant MeSH terms:

Study Results

No Results Posted as of Dec 28, 2020