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.
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.
- Conditions
- Central Venous Catheterization
- 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 group | Role | What they receive |
|---|---|---|
| US group | Experimental | a group underwent real time USG-SCV catheterization Receives: Device: cathetherization approach |
| LM group | Experimental | a 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.
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)
the success's rate in the first attempt
the success's rate in the first attempt
Measured: During the venous cannulation procedure
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.
- First posted30 Dec 2020
- Study start5 Jan 2015
- Primary completion20 Jun 2015
- Study completion20 Jun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Venous CatheterizationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Tunis El Manar
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mechaal Benali, University Tunis El Manar
- Investigators
- mechaal benali, PROFESSOR, Principal investigator, university manar Tunis tunisia
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guidance Versus Anatomical Landmarks for Subclavian Vein Catheterization: a Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT04690296
- Acronym / sponsor ID
- UTEM USG SCV
- Conditions
- Central Venous Catheterization
- Keywords
- ultrasound guidance, central venous catheterization, subclavain vein
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- University Tunis El ManarUniversity, hospital or other
- Study start
- 5 Jan 2015 (actual)
- Primary completion
- 20 Jun 2015 (actual)
- Study completion
- 20 Jun 2015 (actual)
- First posted
- 30 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| US group | Experimental | Device: cathetherization approacha group underwent real time USG-SCV catheterization |
| LM group | Experimental | Device: cathetherization approacha group in whom anatomical LM method was used |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients admitted in intensive care unit requiring a central venous catheter (CVC)
Key exclusion criteria (4 listed)
- • Major blood coagulation disorders,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| cathetherization approachreal time ultrasound guidance versus anatomical landmarks subcalvain vein catheterization | Device | LM group, US group |
Primary outcome
the successful insertion of the catheter.
Time frame: During the venous cannulation procedure
Failure was defined by a number of attempts greater than or equal to five
2 secondary outcomes
the success's rate in the first attempt
Time frame: During the venous cannulation procedure
The evolution of the blood reflux time (success) as a function of the rank of the patients in the 02 groups
Time frame: During the venous cannulation procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Dec 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
mechaal benali, PROFESSOR principal investigator
university manar Tunis tunisia
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.