Clinical trial NCT05399108: Ultrasound Guided Vena Jugularis Interna Catheterization Lateral Approach Short Axis in - Plane Technique
Official title: Ultrasound-guided Vena Jugularis Interna Catheterization Lateral Approach Short Axis in - Plane Technique
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Central Vein Catheter
Keywords: ultrasound guided catheterization
central vein catheterization
jugular vein catheterization
in-plane catheterization
Lead sponsor: Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
Sponsor class: OTHER
First posted: 2022-06-01
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: Central venous access is one of the most frequently used venous accesses in intensive care units. Insertion of the central venous catheter belongs to the basic skills of an intensivist. One of the veins that are available for catheterization is the internal jugular vein. It is recommended to perform jugular vein catheterization along with real-time ultrasound guidance.

Imaging of the jugular vein is usually performed in two ways: on the short axis or on the long axis. The puncture method is described based on the type of needle imaging technique, out-of-plane or in-plane method.

Traditionally, catheterization is performed by a medium approach during imaging the vein on a short axis using the out-of-plane technique. The main advantage of this procedure is proper imaging of the jugular vein and surrounding anatomical structures. However, the limited needle display is rather inconvenient, as only the needle tip can be displayed. This method of central venous catheterization has a first attempt success rate of 80%.

This study is going to concentrate on discussing the performing of jugular vein catheterization by a novel lateral approach in-plane technique during imaging of the vein on the short axis. This procedure for placement of a central venous catheter into the internal jugular vein has not yet been described nor investigated. The above-mentioned method combines the advantage of reliable jugular vein imaging together with proper imaging of the whole needle. At the same time, the fixation of the catheter in the supraclavicular region allows for a better nursing routine, hence increasing the patient's comfort.

Detailed description: All potential candidates to enroll will undergo an examination by an anesthetist. If the candidate meets inclusion/ exclusion criteria, the candidate will sign an informed consent and be enrolled in the study. The calculated number of needed subjects is 180 (90 in each group). In the next step, all enrolled subjects will be randomized by computer block randomization into two groups.

* In group A catheterization of vena jugularis interna will be done by lateral approach with visualization of the vein on its short axis with ultrasound and the in-plane technique will be used.
* In group B catheterization of the vena jugularis interna will be done by conventional approach with visualization of the vein on its short axis with ultrasound and the out-of-plane technique will be used.

Later then all enrolled subjects will undergo examination by an anesthetist or neurologist focused on neurological deficits in the upper limbs. The assessment will be done by Neurological Impairment Scale (NIS).

In the next step catheterization of the vein will be done according to the latest international recommendations and the randomized group.

The time of the start of catheterization and the time of the end of catheterization will be recorded.

On daily basis, there will be done function control of the central vein catheter. The control is done by aspiration from all accesses. Unproblematic aspiration from all accesses will be interpreted as a functional catheter.

On daily basis, there will be done ultrasound control of the catheter to evaluate the presence of thrombosis.

On daily basis, there will be control of the insertion site of the catheter any complications such as signs of an infection or signs of catheter damage will be recorded.

Before extraction of the catheter, there will be examined by an anesthetist or neurologist to evaluate neurological impairment in the upper limbs. The reason and the date of the extraction of the catheter will be recorded.

All measured data will be recorded on the case report form and also will be recorded in the patient's hospital medical documentation. The recorded data will be processed by standard statistical tests such as T-tests and students test.

The aim of this study is to prove the noninferiority of the novel lateral approach.

Eligibility criteria: Inclusion Criteria:

* Patient older than 18 years with an indication of central venous catheter placement

Exclusion Criteria:

* Not signing the informed consent
* BMI under 16,5
* Contraindication of central venous catheter placement into internal jugular vein (thrombosis, site infection, bleeding diseases, anticoagulation or antiaggregation therapy)
* hypersensitivity to sterile ultrasound gel
* neurological impairment on upper limbs
* neurodegenerative disorder

Primary outcomes:
measure: Success rate of first attempt
timeFrame: Measured from the time the cannulation starts (local anesthetic infiltration) till insertion of the catheter, up to 120 minutes.
Secondary outcomes:
measure: Rate of complications
timeFrame: Measured from the start of cannulation (local anesthetic infiltration) till extraction of the catheter, up to 45 days.
measure: Risk of neurological impairment assessed by Neurological Impairment Scale
timeFrame: Measured from insertion the catheter till the extraction of the catheter, up to 45 days.
measure: Functional time of the catheter
timeFrame: Measured from inserting the catheter till the extraction of the catheter, up to 45 days.
Other outcomes:
Locations:
city: Ústí Nad Labem
country: Czechia
facility: Masarykova Nemocnice v Ústí nad Labem, Krajská Zdravotní a.s.
state: Ústí Nad Labem Region
Study officials:
affiliation: Krajská Zdravotní a.s. Masarykova Nemocnice v Ústí nad Labem
name: Michal Kalina, MUDr.
role: PRINCIPAL_INVESTIGATOR
References: