Central Vein CatheterNCT05399108
Ultrasound Guided Vena Jugularis Interna Catheterization Lateral Approach Short Axis in - Plane Technique
A study testing Ultrasound Guided Lateral Approach Catheterization of Jugular Internal Vein and Ultrasound Guided Conventional Approach Catheterization of Jugular Internal Vein in people with Central Vein Catheter, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Central Vein Catheter
- What is being tested?
- Ultrasound Guided Lateral Approach Catheterization of Jugular Internal Vein and Ultrasound Guided Conventional Approach Catheterization of Jugular Internal Vein
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteCzechia
- Study dates
- 25 Jul 2022to 30 Jan 2024
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient older than 18 years with an indication of central venous catheter placement
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Czechia1 site
Masarykova Nemocnice v Ústí nad Labem, Krajská Zdravotní a.s.
Ústí nad Labem, Ústí nad Labem Region, 40001
About this study
Official title: Ultrasound-guided Vena Jugularis Interna Catheterization Lateral Approach Short Axis in - Plane Technique
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.
Read more
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.
Read the 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.
- Conditions
- Central Vein Catheter
- Being tested
- Ultrasound Guided Lateral Approach Catheterization of Jugular Internal Vein, Ultrasound Guided Conventional Approach Catheterization of Jugular Internal Vein
- Keywords
- ultrasound guided catheterization, central vein catheterization, jugular vein catheterization, in-plane catheterization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Lateral Approach Catheterization of Jugular Internal VeinProcedure or surgery
The jugular internal vein is displayed on its short axis. On the image are displayed the trapezius muscle and layers of skin. Just above the trapezius muscle using the in-plane technique is done puncture of the vein. By Seldinger's technique, catheterization is done. The whole procedure is done according to the newest international recommendations for central vein catheterization.
Ultrasound Guided Conventional Approach Catheterization of Jugular Internal VeinProcedure or surgery
The jugular internal vein is displayed on its short axis. The cannulation is done by the conventional approach (middle approach - the most frequently used).
| Study group | Role | What they receive |
|---|---|---|
| The Novel Lateral Approach | Experimental | In this arm, the catheterization of the internal jugular vein is done with ultrasound guidance displaying the vein on its short axis using a lateral approach and in-plane technique. The catheterization is done according to the newest international recommendations for good clinical practice. Receives: Procedure: Ultrasound Guided Lateral Approach Catheterization of Jugular Internal Vein |
| The Conventional Approach | Active comparator | In this group catheterization of the jugular internal vein is done by conventional approach with ultrasound guidance using displaying on its short axis and using the out-of-plane technique. Receives: Procedure: Ultrasound Guided Conventional Approach Catheterization of Jugular Internal Vein |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of first attempt
Primary outcome is to prove that first attempt success rate by the novel approach is comparable with the success rate of the first attempt success rate of the conventional approach.
Measured: Measured from the time the cannulation starts (local anesthetic infiltration) till insertion of the catheter, up to 120 minutes.
Secondary outcomes (3)
Rate of complications
Secondary outcome is to prove that rate of complications between both approaches the novel one and the conventional one are comparable.
Measured: Measured from the start of cannulation (local anesthetic infiltration) till extraction of the catheter, up to 45 days.
Risk of neurological impairment assessed by Neurological Impairment Scale
Secondary outcome is to prove that risk of developing new neurological impairment is comparable between the novel approach and the conventional approach. We will assess the neurological impairment by Neurological Impairment Scale. This scale identify whether there is or there is not neurological impairment and distinguish between motor or sensory impairment. Maximum points for one upper limb if five. Minimum points for upper lim is zero. Zero points means there is no neurological impairment. Five points means there is neurological impairment in all segments from C5 to T1.
Measured: Measured from insertion the catheter till the extraction of the catheter, up to 45 days.
Functional time of the catheter
Secondary outcome is to prove that functional time of the catheter is comparable between the novel approach and the conventional approach.
Measured: Measured from inserting the catheter till the extraction of the catheter, up to 45 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2022
- Study start25 Jul 2022
- Primary completion1 Dec 2023
- Study completion30 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Vein CatheterStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michal Kalina, Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.
- Investigators
- Michal Kalina, MUDr., Principal investigator, Krajská Zdravotní a.s. Masarykova Nemocnice v Ústí nad Labem
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05399108
- Sponsor's protocol ID
- UltrasoundLateralCannulation
- Status last verified
- Feb 2024
- First submitted
- 23 May 2022
- Last updated
- 20 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Vena Jugularis Interna Catheterization Lateral Approach Short Axis in - Plane Technique
- ClinicalTrials.gov ID
- NCT05399108
- Acronym / sponsor ID
- UltrasoundLateralCannulation
- Conditions
- Central Vein Catheter
- Keywords
- ultrasound guided catheterization, central vein catheterization, jugular vein catheterization, in-plane catheterization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.University, hospital or other
- Study start
- 25 Jul 2022 (actual)
- Primary completion
- 1 Dec 2023 (actual)
- Study completion
- 30 Jan 2024 (actual)
- First posted
- 1 Jun 2022 (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.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The Novel Lateral Approach | Experimental | Procedure: Ultrasound Guided Lateral Approach Catheterization of Jugular Internal VeinIn this arm, the catheterization of the internal jugular vein is done with ultrasound guidance displaying the vein on its short axis using a lateral approach and in-plane technique. The catheterization is done according to the newest international recommendations for good clinical practice. |
| The Conventional Approach | Active comparator | Procedure: Ultrasound Guided Conventional Approach Catheterization of Jugular Internal VeinIn this group catheterization of the jugular internal vein is done by conventional approach with ultrasound guidance using displaying on its short axis and using the out-of-plane technique. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patient older than 18 years with an indication of central venous catheter placement
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| Ultrasound Guided Lateral Approach Catheterization of Jugular Internal VeinThe jugular internal vein is displayed on its short axis. On the image are displayed the trapezius muscle and layers of skin. Just above the trapezius muscle using the in-plane technique is done puncture of the vein. By Seldinger's technique, catheterization is done. The whole procedure is done according to the newest international recommendations for central vein catheterization. | Procedure or surgery | The Novel Lateral Approach |
| Ultrasound Guided Conventional Approach Catheterization of Jugular Internal VeinThe jugular internal vein is displayed on its short axis. The cannulation is done by the conventional approach (middle approach - the most frequently used). | Procedure or surgery | The Conventional Approach |
Primary outcome
Success rate of first attempt
Time frame: Measured from the time the cannulation starts (local anesthetic infiltration) till insertion of the catheter, up to 120 minutes.
Primary outcome is to prove that first attempt success rate by the novel approach is comparable with the success rate of the first attempt success rate of the conventional approach.
3 secondary outcomes
Rate of complications
Time frame: Measured from the start of cannulation (local anesthetic infiltration) till extraction of the catheter, up to 45 days.
Risk of neurological impairment assessed by Neurological Impairment Scale
Time frame: Measured from insertion the catheter till the extraction of the catheter, up to 45 days.
Functional time of the catheter
Time frame: Measured from inserting the catheter till the extraction of the catheter, up to 45 days.
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 20 Feb 2024.
- Individual participant dataSharing planned: No
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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.
Michal Kalina, MUDr. principal investigator
Krajská Zdravotní a.s. Masarykova Nemocnice v Ústí nad Labem
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound Guided Lateral Approach Catheterization of Jugular Internal Vein and Ultrasound Guided Conventional Approach Catheterization of Jugular Internal Vein in people with Central Vein Catheter, run by Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s. at 1 site in Czechia.
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 6 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Success rate of first attempt (time frame: Measured from the time the cannulation starts (local anesthetic infiltration) till insertion of the catheter, up to 120 minutes.). 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 20 Feb 2024.