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Clinical Trials/NCT05409768
NCT05409768
Recruiting
Not Applicable

Comparison of Short Axis Out of Plane Method and Anteroposterior Short Axis in Plane Method in Ultrasound-guided Central Venous Catheterizations

Abant Izzet Baysal University2 sites in 1 country100 target enrollmentAugust 1, 2022

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Central Venous Catheterization
Sponsor
Abant Izzet Baysal University
Enrollment
100
Locations
2
Primary Endpoint
Number of puncture attempts
Status
Recruiting
Last Updated
3 years ago

Overview

Brief Summary

Ultrasound guidance in central venous catheterization has become the standard for clinical practice. Many approaches have been described in ultrasound guided catheterization procedures. The aim of this study is to compare the classical short axis out of plane (SAX-OOP) approach and the new anteroposterior short axis in plane (APSAX-IP approach in central jugular venous catheterization. The study was planned as prospective randomized and controlled. One hundred patients were planned to be included in this study.

Patients will be divided into two groups: Central jugular vein catheterization will be performed with the short axis out of plane group (ultrasound transducer will be positioned classically from medial to lateral in the neck) and anteroposterior short axis in plane group (ultrasound transducer will be positioned laterally from anterior to posterior on the neck). The two groups will be compared in terms of number of puncture attempts, duration of the procedure, ultrasound scan time before the procedure, number of needle redirection, overall success rate, complications, ease of catheterization and ultrasound visibility.

Detailed Description

Central venous catheterization is a method frequently used in intensive care patients and patients to be operated. With classical methods, this central venous vascular access procedure in the landmark method can be performed or it can be successfully performed under ultrasound guidance. Ultrasound-guided central venous catheterization is a safer and recommended approach. During venous catheterization with ultrasound the vein and its neighborhood can be easily visualized and it can be followed while the needle is directed to the target in vein puncture. Undesirable complications (hematoma, pneumothorax, arterial puncture) also decrease with the decrease in the number of punctures under ultrasound guidance. Ultrasound guided central catheterization which facilitates safer and faster procedures constitutes an important area for patient care. With the development of technology and the increase in accessibility it constitutes an important and useful area in the interventions made with ultrasound. The internal jugular vein is a frequently chosen central venous structure. Many ultrasound-guided imaging and intervention methods have been described for catheterization of the internal jugular vein with the Seldinger method. These are described as longitudinal (long axis), transverse (short axis) and oblique methods for imaging and probe position. The image taken with the position of the needle relative to the ultrasound probe is described as in plane and out of plane. Each method may have advantages over each other and can be preferred according to the patient's condition and the experience of the practitioner. Successful and safe catheterizations can be performed in the internal jugular vein with the short axis out-of-plane (SAX-OOP) method which is especially used in adults . Short axis out of plane is a successful method that can almost be called a classic that comes to mind first. Compared to other needle imaging methods out of plane tracking of the needle (as a point) seems to be a disadvantage in the user's imaging compared to the in-plane tracking method. Of course, it is easier and faster to capture the short axis when imaging the venous structure as long axis or short axis with ultrasound. The " Anteroposterior short axis in plane" (APSAX-IP) technique is first reported by Aithal G. et al. in 2019. The use of both short axis and in-plane approaches has been described.The difference of the anteroposterior short axis in plane (APSAX-IP ) technique from the classical short axis out of plane (SAX-OOP) technique is that the location of the ultrasound is lateral to the neck, the needle is about 2-3 cm away from the ultrasound, the entry area from the skin, the needle is advanced subcutaneously in the anteroposterior direction, not medially, and the needle is not as a point in ultrasound that can be viewed longitudinally. It is thought that the APSAX-IP method has advantages such as easier follow-up of the needle, easier monitoring of the progression of the needle without damaging the posterior wall by seeing a large anterior posterior diameter of the vessel. It is stated that the APSAX-IP method will be more ergonomic in patients with short neck anatomy, obese and pediatric patients due to the location of the ultrasound probe. One method may be preferred over the other in patients. Although the definition of the method has been made, it has not been compared with any catheterization method. The aim of our study is to compare the classical SAX-OOP method and the newly defined APSAX-IP method in terms of difficulty, needle puncture time, needle procedure time and complications.

Registry
clinicaltrials.gov
Start Date
August 1, 2022
End Date
December 31, 2023
Last Updated
3 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Ilker Ital

Assistant Professor Doctor

Abant Izzet Baysal University

Eligibility Criteria

Inclusion Criteria

  • Patients that are planned a central venous catheter placement

Exclusion Criteria

  • Morbid obese patients (body mass index\> 40)
  • People with severe coagulopathy
  • Severe deformity at the neck
  • Skin deformity or infection at catheterization site
  • Congenital anomalies of central veins
  • Emergency operations

Outcomes

Primary Outcomes

Number of puncture attempts

Time Frame: From the 1st second through withdrawal of the needle, up to 3 minutes

Number of needle insertions to the catheterization region for placing a catheter

Cannulation procedural time

Time Frame: During the procedure, starting from the 1st second through placement of the catheter; up to 3 minutes

Duration of the whole cannulation procedure

Catheterization procedural time

Time Frame: During the procedure, starting from the 1st second through placement of the catheter; up to 3 minutes

Duration of the whole catheterization procedure

Complications

Time Frame: Through study completion, an average of 4 months ]

Rate of complications that occur during catheterization procedure

Success rate

Time Frame: Through catheterizations completion, an average of 4 months

Correct placement of the catheter over the guidewire after central vein puncture

Success rate at first attempt

Time Frame: Through study completion, an average of 4 months

Success rate at first attempt of the procedures in each group

Number of needle redirections

Time Frame: During the whole cannulation procedure

Redirections of the needle towards the vessel

Secondary Outcomes

  • Guide-wire visualization(Throughout the procedure; up to 3 minute)
  • Vessel visualization(Throughout the procedure; up to 3 minutes)
  • Needle visualization(Throughout the procedure; up to 3 minutes)
  • Ease of the catheterization process(Throughout the procedure; up to 3 minutes)
  • Ultrasound time(Throughout the pre-procedural ultrasonography; up to 10 minutes)

Study Sites (2)

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