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Central Venous CatheterizationNCT04690296

Ultrasound Guidance Versus Anatomical Landmarks for Subclavian Vein Catheterization

A study testing cathetherization approach in people with Central Venous Catheterization, run by University Tunis El Manar.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Central Venous Catheterization
What is being tested?
cathetherization approach
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
70 participants
Where
No sites listed yet
Study dates
5 Jan 2015to 20 Jun 2015
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients admitted in intensive care unit requiring a central venous catheter (CVC)

Who cannot join

  • • Major blood coagulation disorders,
  • Any thrombotic formations within the vein,
  • Congenital or acquired deformity of neck or clavicle
  • Cannulation site infection, hematoma and surgery

About this study

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

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.

Read the detailed 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.

Being tested
cathetherization approach
Keywords
ultrasound guidance, central venous catheterization, subclavain vein

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • cathetherization approachDevice

    real time ultrasound guidance versus anatomical landmarks subcalvain vein catheterization

Study groups in NCT04690296
Study groupRoleWhat they receive
US groupExperimentala group underwent real time USG-SCV catheterization
Receives: Device: cathetherization approach
LM groupExperimentala group in whom anatomical LM method was used
Receives: Device: cathetherization approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. the successful insertion of the catheter.

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

    Measured: During the venous cannulation procedure

Secondary outcomes (2)
  1. the success's rate in the first attempt

    the success's rate in the first attempt

    Measured: During the venous cannulation procedure

  2. The evolution of the blood reflux time (success) as a function of the rank of the patients in the 02 groups

    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

    Measured: During the venous cannulation procedure

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2020
  2. Study start5 Jan 2015
  3. Primary completion20 Jun 2015
  4. Study completion20 Jun 2015

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Basic science
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Participant
Enrolment
70 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04690296
Sponsor's protocol ID
UTEM USG SCV
Status last verified
Dec 2020
First submitted
27 Dec 2020
Last updated
30 Dec 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A study testing cathetherization approach in people with Central Venous Catheterization, run by University Tunis El Manar.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

the successful insertion of the catheter. (time frame: During the venous cannulation procedure). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2020.

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