Clinical trial NCT04256564: Comparison of Two Syringe-free In-plane Techniques in Ultrasound-guided Central Venous Catheterization
Official title: Comparison of Two Syringe-free In-plane Techniques in Ultrasound-guided Central Venous Catheterization: Jugular Venous Catheterization With Oblique Approach and Brachiocephalic Catheterization Using Y-shape Image
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Central Venous Catheter Placement
Keywords: Central venous catheter
Ultrasound
Jugular vein
Brachiocephalic vein
Endocavity micro-convex probe
Y-Shape
Lead sponsor: Kutahya Health Sciences University
Sponsor class: OTHER
First posted: 2020-02-05
Enrollment: 80
Sex: ALL
Minimum age (years): 19
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: There will be two parallel groups in each a different central catheterization method will be performed.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Ultrasound guidance has become a standard for central venous catheterization. The aim of this study is to compare jugular venous catheterization by using lateral oblique approach to brachiocephalic catheterization by using Y-shape imaging. The trial is planned as prospective randomized and single-blind study. Eighty patients are planned to include in this study. Patients will be assigned to two groups: Oblique visualization Group (central catheter will be placed to the jugular vein by using ultrasound-guided in-plane syringe-free technique) and Y-shape visualization Group (central catheter will be placed to the brachiocephalic vein by using ultrasound-guided in-plane syringe-free technique). Two groups will be compared in terms of number of puncture attempts, procedural time, time of preprocedural ultrasound scanning, overall success rate, complications, the ease of the catheterization process and ultrasound visibility.

Detailed description: Central venous catheters are frequently placed in the operating rooms, intensive care units and emergency departments for various indications such as intravenous fluid, drug infusion, measurement of cardiac parameters and lack of vascular access. Ultrasound guidance has become a standard for central venous catheterization. The use of ultrasound has reduced the number of puncture attempts, increased success rate and reduced complications. While the central venous catheter is inserted by ultrasound, the vessels and the needle can be imaged in real-time. In plane and out-of-plane imaging techniques can be used during catheterization. The in-plane technique ensures the entire needle visualization in ultrasound images. With the linear ultrasound probe, the vessel and needle are imaged longitudinally in the in-plane technique. When an endocavity (micro-convex) ultrasound probe is used, three central vessels (jugular, subclavian and brachiocephalic veins) are displayed as Y-shape. The advantage of the endocavity (micro-convex) probe is that it can visualize deeper tissues and deep veins, and more tissues can be imaged in wider angle. Both techniques have been successfully applied in central catheter placement. In-plane technique also ensures syringe-free cannulation where blood aspiration with a syringe attached to the needle is not necessary.

The aim of this study is to compare two different ultrasound guided in-plane techniques for central venous catheterization. The investigators planned to compare jugular venous catheterization using a linear probe and lateral oblique approach to brachiocephalic catheterization using a micro-convex probe and Y-shape imaging.

The primary outcomes are number of puncture attempts, success rate at first attempt, overall success rate, procedure time, ultrasound scanning time and rate of complications. Secondary outcomes are visibility of the veins and the needle in ultrasound images.

The trial is a comparison of two different interventional technique and planned as prospective randomized and single-blind study. Patients aged between 18-85 years that are planned central venous catheter placement will be included in the study. Patients included in the study will be assigned into two groups by computer-assisted randomization. In the first group (Oblique visualization Group), central catheter will be placed to the jugular vein by using ultrasound-guided in-plane syringe-free technique. In the second group (Y-shape visualization Group), central catheter will be placed to the brachiocephalic vein by using ultrasound-guided in-plane syringe-free technique Linear ultrasound probe will be used in the first group, and endocavity (micro-convex) ultrasound probe will be used in the second group.

In both groups, the number of puncture attempts, the number of needle redirections, and the procedure time will be recorded. The time of preprocedural ultrasound scanning will be recorded in both groups. In addition, complications during the procedure such as bleeding, hemothorax, pneumothorax, hematoma and carotid vascular injury will be recorded. Overall success rates will be assessed in each group at the end of the study. A catheterization procedure will be considered as "unsuccessful" after third puncture attempt or more than 10 needle redirections are needed or requires a procedure time more than 3 minutes. At this moment, the catheter will be placed to a different region or the investigators will switch to a different approach. The ease of the catheterization process will be scored between 0 and 10 by the investigator performing the process (0: the hardest, 10: the easiest). The ultrasound visibility of the needle, vessels, guide wire and catheter will be scored between 0 and 4 (4: excellent view, 3: good view, 2: Medium, 1: difficult 0: impossible to image). The recorded data will be compared between the two groups.

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

Primary outcomes:
measure: Number of puncture attempts
timeFrame: During the whole cannulation procedure, starting from the 1st minute until the end of the procedure
measure: Cannulation procedural time
timeFrame: From the 1st minute through withdrawal of the needle, up to 3 minutes
measure: Catheterization procedural time
timeFrame: During the procedure, starting from the 1st minute through placement of the catheter; up to 3 minutes
measure: Number of needle redirections
timeFrame: During the whole cannulation procedure, starting from the 1st minute through the procedure; assessed up to 3 minutes
measure: Success rate
timeFrame: Through study completion, an average of 4 months
measure: Success rate at first attempt
timeFrame: Through study completion, an average of 4 months
measure: Complications
timeFrame: Through study completion, an average of 4 months
Secondary outcomes:
measure: Vessel visualization
timeFrame: Throughout the procedure; up to 3 minutes
measure: Needle visualization
timeFrame: Throughout the procedure; up to 3 minutes
measure: Guide-wire visualization
timeFrame: Throughout the procedure; up to 3 minutes
measure: Catheter visualization
timeFrame: At the end of catheterization procedure
measure: Ease of the catheterization process
timeFrame: Throughout the procedure; up to 3 minutes
measure: Ultrasound time
timeFrame: Throughout the pre-procedural ultrasonography; up to 10 minutes
Other outcomes:
Locations:
city: Kutahya
country: Turkey
facility: Kutahya Health Sciences University, Evliya CelebiHospital
Study officials:
affiliation: Kutahya Health Sciences University
name: Onur Balaban, MD.
role: PRINCIPAL_INVESTIGATOR
References:
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