Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT04690296 |
| Other study ID # |
UTEM USG SCV |
| Secondary ID |
|
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 5, 2015 |
| Est. completion date |
June 20, 2015 |
Study information
| Verified date |
December 2020 |
| Source |
University Tunis El Manar |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
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.
Description:
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.
