This was a prospective randomized study. After prior approval by the Ethics Committee, we
included all patients aged over 18 years- old who were admitted to the intensive care
unit (ICU) and who required a central venous catheterization (CVC) outside the
emergency's context. Non-inclusion criteria were thrombosis of the vein or coagulopathy.
All catheterizations were done by the same non-experimented practitioner. Patients were
randomized into two groups according to the catheterization's technique of subclavain
vein: real-time long axis ultrasound guidance (US group) and anatomical landmarks ( LM
group). The main outcome was success. The secondary outcomes were: success' rate at first
puncture, number of punctures, rate of redirections, number of redirections, access's
time, preparation and spotting time and rate of complications (arterial puncture,
hematoma, pneumothorax, wrong position of the catheter).

Data analysis was performed using the SPSS® software version 20: The Student's "t" test
was used to compare the normally distributed quantitative variables, the Mann-Whitney's
test for non-normally distributed quantitative variables and the Chi-square and Fisher
tests for qualitative data. A value of p <0.05 was considered as statistically
significant.

Ultrasound Guidance Versus Anatomical Landmarks for Subclavian Vein Catheterization

Central Venous Catheterization

Methods:

Study population:

It was a prospective randomized study, conducted in the ICU after obtaining approval by
the local ethics committee.

We enrolled all patients older than 18 years and requiring a CVC in non emergent
conditions after obtaining a written informed consent from the patient or trusted person.

The exclusion criteria were the vein thrombosis and the existence of a coagulopathy.

Patients were randomly divided according to computer generated randomized table into
twogroups: a group underwent real time USG-SCV catheterization (US group) and a group in
whom anatomical LM method was used (LM group).

Methods:

All procedures were performed by the same novice operator trained in CVC placement, each
of whom had performed at least 10 catheterization using both techniques on cadavers
before standing the study.

All patients were mechanically ventilated, they underwent ultrasound scanning of the
infraclavicular area to detect an eventual venous thrombosis and they put in
trendelenburg position with a block under the homolateral shoulder.

Techniques:

The anterosuperior region of the chest was prepared in a sterile way for both approach In
the LM group, we chose the Aubaniac technique to cannulate the SCV(10) . The needle was
inserted 1 cm inferior and laterally to the junction of the medial one-third and lateral
two-thirds of the clavicle, it was passed below the clavicle and above the first rib and
it was advanced parallel to the floor, through the subclavian muscle, until it entered
the subclavian vein.

The intravascular position of the catheter was approved by venous blood's reflux.

In the US group, we chose the infraclavicular approach with long axis view(11). A
portable ultrasound unit (Mindray M7®, Shenzhen, China) equipped with a 12 MHz linear
transducer was used. The probe was covered with ultrasonic gel and wrapped in a sterile
sheath. The first step was to visualize the SCV and the artery in a short axis view.
Then, maneuvers of the transducer were performed to expose the axillary vein and in its
continuation till the SCV on the longitudinal axis to achieve an optimum plane of
catheterization.The probe was handled by the non-dominant hand. The needle was introduced
slowly with the dominant hand so that its tip's trajectory could be detected
superficially. It was advanced in real-time toward the lumen of the vein, on the
longitudinal axis, while it was directed toward the acoustic shadow of the thoracic rib
underneath. This leads to minimize the risk of damaging the pleurae and the lung in case
of an vein's transfixion. Hence, the needle entered the lumen of the vessel either at the
level of the axillary vein or at the level of its medial continuation by the SCV . After
that,venous blood returned in the syringe.

In the both technique, the guidewire and the catheter were advanced according to the
Seldinger's technique (12).

Chest X-ray was used to evaluate the position of the catheter's tip and to detect
pneumothorax. Hematoma was detected by ultrasonography.

Demographic characteristics, presence of risks factors for difficult venous
catheterization and side of cannulation were recorded for all patients.

The primary outcome was the successful insertion of the catheter. Failure was defined by
a number of attempts greater than or equal to five.

The secondary and comes were: the success's rate in the first attempt, the number of
attempts, redirections rate, number of redirections, access time (defined as the time
between the skin puncture and the return of venous blood) and complications such as
hematoma, pneumothorax, arterial puncture and malposition.

Statistical analysis:

Sample size was calculated assuming a difference of proposition of success rate at 20%
with a statistical power of 0.85 (alpha = 0.05). The precise sample size estimation was
33 per group and 66 in totals.

Statistical analysis were performed using SPSS 200 software. Normal distributions of
continuous variables were compared using Student t-test .Mann-Whitney U test was used for
continuous variables without normal distribution. Categorical variables were compared
using the χ2 test and Fisher exact test. Data were expressed as mean ± SD or as median
(25th percentile - 75th percentile). A p value (two-sided in all tests) of 0.05 was
considered significant. A linear regression was used to evaluate the relation between
access's time and patient's range.

cathetherization approach

Ultrasound Guidance Versus Anatomical Landmarks for Subclavian Vein Catheterization: a Prospective Randomized Study

Failure was defined by a number of attempts greater than or equal to five

Professor

procedures were performed by the same novice operator trained in CVC placement.we studied
the relationship between the rank of patients and the success rate

a group underwent real time USG-SCV catheterization

a group in whom anatomical LM method was used

Ultrasound Guidance Versus Anatomical Landmarks for Subclavian Vein Catheterization

About this trial

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Placebo

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