Central Venous Catheters/Standardssyringe-freeNCT07547397
COMPARISON OF CLASSICAL AND SYRINGE-FREE TECHNIQUES IN ULTRASOUND-GUIDED CENTRAL JUGULAR VENOUS CATHETERIZATION
A study testing out-of-plane technique and in-plane technique in people with Central Venous Catheters/Standards and Ultrasonography/Methods, run by ALİEMAN.
Trial summary
During central venous catheterization, both in-plane and out-of-plane techniques can be used. In the in-plane technique, the entire needle can be visualized with ultrasound. In the in-plane technique with a linear probe, the vessel and needle are visualized longitudinally. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Central Venous Catheters/Standards, Ultrasonography/Methods, Ultrasonography/Standards
- What is being tested?
- out-of-plane technique and in-plane technique
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 30 Mar 2026to Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-85 years who have an indication for central venous catheterization in the operating room.
Who cannot join
- Morbidly obese patients (body mass index >40)
- Those with severe coagulopathy
- Severe neck deformity
- Skin deformity or infection at the catheterization site
- Those with congenital anomalies in the central veins
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Onur Balaban, medical doctor contact
About this study
During central venous catheterization, both in-plane and out-of-plane techniques can be used. In the in-plane technique, the entire needle can be visualized with ultrasound. In the in-plane technique with a linear probe, the vessel and needle are visualized longitudinally. In the syringe technique, a guide needle attached to a syringe is first inserted into the vein and blood is aspirated, then the catheter is placed through a wire sent into the vein via the needle. This procedure is performed under ultrasound guidance, visualizing the vessels, guide wire, and needle.
In the syringe-less technique, the guide wire is placed inside the needle and sent directly into the vein. In this technique, there is no need to draw blood into the syringe to confirm that it is in the vein.
The aim of our study is to compare the two ultrasound-guided techniques in terms of procedure time, number of attempts, and complication rates. We expect the syringe-less technique to have a shorter procedure time, fewer attempts, and a lower complication rate.
Read the detailed description
Today, central venous catheters are frequently placed in operating rooms, intensive care units, and emergency departments for reasons such as intravenous fluid and drug infusion, measurement of cardiac parameters, inability to find a vein, total parenteral nutrition, septic shock, and similar critical illnesses. Performing central venous catheterization under ultrasound guidance has reduced the number of attempts, procedure time, and intra-procedure complications. International guidelines recommend the standard use of ultrasound in central venous catheterization. During ultrasound-guided central venous catheter placement, the vessels and needle can be simultaneously visualized. Both in-plane and out-of-plane techniques can be used during the catheterization procedure. In the in-plane technique, the entire needle is visualized by ultrasound. In the in-plane technique with a linear probe, the vessel and needle are visualized longitudinally. In the syringe technique, a guide needle attached to a syringe is first inserted into the vein to aspirate blood, and then the catheter is placed through a wire sent into the vein via the needle. This procedure is performed under ultrasound guidance, visualizing the vessels, guide wire, and needle.
In the syringe technique, a guide needle attached to a syringe is first inserted into the vein to aspirate blood, and then the catheter is placed through a wire sent into the vein via the needle. In the syringe-free technique, a guide wire is placed inside the needle and directly inserted into the vein. In this technique, there is no need to draw blood into a syringe to confirm that the needle is in the vein.
The aim of our study is to compare two ultrasound-guided techniques in terms of procedure time, number of attempts, and complication rates. We expect the syringe-free technique to have a shorter procedure time, fewer attempts, and a lower complication rate.
Materials and Methods Section:
The study was designed as a prospective, randomized, and single-blind study. Patients aged 18-85 years with an indication for central venous catheterization will be included in the study. Informed consent will be obtained from patients who will undergo surgery under general anesthesia before the anesthesia procedure.
Patients included in the study will be divided into two groups using computer-assisted randomization.
Patients in the first group will undergo central catheterization of the jugular vein using the Seldinger method (first inserting a guide wire and then inserting the catheter) with ultrasound guidance using an out-of-plane technique.
In the second group of patients, central jugular vein catheterization will be performed using the Seldinger method (with a guide wire) with in-plane technique (longitudinal visualization of the entire needle and vessel) under ultrasound guidance. A linear ultrasound probe will be used in both groups of patients during the procedure. The number of needle insertions, needle placements, number of attempts, and procedure time will be recorded and compared for both groups. In addition, rare complications such as bleeding, hemothorax, pneumothorax, hematoma, and carotid artery injury will be recorded. The ease of the procedure will be scored by the practitioner on a scale of 0 to 10 (0: most difficult, 10: easiest). The appearance of the needle, vessels, guide wire, and catheter on ultrasound will also be scored and recorded on a scale of 1 to 5 (very difficult: 1, difficult: 2, moderate: 3, easy appearance: 4, excellent: 5).
The recorded data will be compared between the two groups.
Inclusion Criteria:
Patients aged 18-85 years with indications for central venous catheterization in the operating room.
Exclusion Criteria:
Morbidly obese patients (BMI >40) Patients with severe coagulopathy Patients with severe neck deformity Patients with skin deformity or infection at the catheterization site Patients with congenital anomalies in the central veins
Sample Selection:
Considering previous studies on this subject, a total of 80 patients in both groups are needed to shorten the procedure time by 30%. Considering patients who may be excluded from the study, a total of 90 patients were planned to be included (α: 0.05, power 90%).
Statistical Method to be Used:
Continuous quantitative data will be presented as number, mean ± standard deviation. Qualitative variables will be expressed as median, 25th and 75th percentiles. Continuous variables with independent measurements and a normal distribution will be analyzed using the T-test. For data that do not show a normal distribution, the Mann-Whitney test will be applied. Chi-square tests will be applied to categorical data, and p <0.05 will be considered statistically significant.
- Being tested
- out-of-plane technique, in-plane technique
- Keywords
- central venous catheterization with and without syringe
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
out-of-plane techniqueProcedure or surgery
ultrasound-guided out-of-plane technique for central venous catheterization
in-plane techniqueProcedure or surgery
In the syringe-free technique, a guide wire is placed inside the needle and sent directly into the vein. In this technique, there is no need to draw blood into the syringe to confirm its presence in the vein. Using ultrasound-guided in-plane technique (with the entire needle and vein visualized longitudinally), central catheterization of the jugular vein will be performed using the Seldinger method (with a guide wire).
| Study group | Role | What they receive |
|---|---|---|
| with a syringe | Experimental | Central catheterization of the jugular vein will be performed using the Seldinger method (first inserting a guide wire, then placing the catheter over it) with ultrasound guidance and an out-of-plane technique. A guide needle attached to a syringe will be inserted into the vein to aspirate blood, and then a catheter will be placed over the wire sent into the vein through the needle. This procedure will be performed under ultrasound guidance, visualizing the veins, guide wire, and needle. Receives: Procedure: out-of-plane technique |
| syringe-free technique | Active comparator | In the syringe-free technique, a guide wire will be placed inside the needle and sent directly into the vein. In this technique, central jugular vein catheterization will be performed using the Seldinger method (using a guide wire) with an in-plane approach (visualizing the entire needle and vein longitudinally). There is no need to draw blood into a syringe to confirm that the needle is in the vein. Receives: Procedure: in-plane technique |
What is being measured
The primary outcome is the main question the study is designed to answer.
processing time
The technique to be used will be determined according to the randomization performed. The procedure time will begin at the moment of the first needle insertion (syringe or catheter needle) after skin cleansing and will end at the placement of the jugular catheter without suturing.
Measured: The procedure time is expected to be 30% shorter with the syringe-free technique. Catheter insertion is expected to take around 120 seconds.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2026
- Study start30 Mar 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Central Venous Catheters/StandardsStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ALİEMAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, ALİEMAN, Sakarya University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07547397
- Sponsor's protocol ID
- balaban jugular catheter
- Acronym
- syringe-free
- Status last verified
- Apr 2026
- First submitted
- 17 Apr 2026
- Last updated
- 23 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Patient demographic data Study protocol Statistical analysis data
Publications
Balaban O, Turgut M, Aydin T. Ultrasound-guided supraclavicular brachiocephalic vein catheterization in children: Syringe-free in-plane technique with micro-convex probe. J Vasc Access. 2020 Mar;21(2):241-245. doi: 10.1177/1129729819867221. Epub 2019 Sep 6.
PubMed 32174238
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- COMPARISON OF CLASSICAL AND SYRINGE-FREE TECHNIQUES IN ULTRASOUND-GUIDED CENTRAL JUGULAR VENOUS CATHETERIZATION
- ClinicalTrials.gov ID
- NCT07547397
- Acronym / sponsor ID
- syringe-free / balaban jugular catheter
- Keywords
- central venous catheterization with and without syringe
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- ALİEMANUniversity, hospital or other
- Study start
- 30 Mar 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 23 Apr 2026 (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.
During central venous catheterization, both in-plane and out-of-plane techniques can be used. In the in-plane technique, the entire needle can be visualized with ultrasound. In the in-plane technique with a linear probe, the vessel and needle are visualized longitudinally. In the syringe technique, a guide needle attached to a syringe is first inserted into the vein and blood is aspirated, then the catheter is placed through a wire sent into the vein via the needle. This procedure is performed under ultrasound guidance, visualizing the vessels, guide wire, and needle.
In the syringe-less technique, the guide wire is placed inside the needle and sent directly into the vein. In this technique, there is no need to draw blood into the syringe to confirm that it is in the vein.
The aim of our study is to compare the two ultrasound-guided techniques in terms of procedure time, number of attempts, and complication rates. We expect the syringe-less technique to have a shorter procedure time, fewer attempts, and a lower complication rate.
Detailed description
Today, central venous catheters are frequently placed in operating rooms, intensive care units, and emergency departments for reasons such as intravenous fluid and drug infusion, measurement of cardiac parameters, inability to find a vein, total parenteral nutrition, septic shock, and similar critical illnesses. Performing central venous catheterization under ultrasound guidance has reduced the number of attempts, procedure time, and intra-procedure complications. International guidelines recommend the standard use of ultrasound in central venous catheterization. During ultrasound-guided central venous catheter placement, the vessels and needle can be simultaneously visualized. Both in-plane and out-of-plane techniques can be used during the catheterization procedure. In the in-plane technique, the entire needle is visualized by ultrasound. In the in-plane technique with a linear probe, the vessel and needle are visualized longitudinally. In the syringe technique, a guide needle attached to a syringe is first inserted into the vein to aspirate blood, and then the catheter is placed through a wire sent into the vein via the needle. This procedure is performed under ultrasound guidance, visualizing the vessels, guide wire, and needle.
In the syringe technique, a guide needle attached to a syringe is first inserted into the vein to aspirate blood, and then the catheter is placed through a wire sent into the vein via the needle. In the syringe-free technique, a guide wire is placed inside the needle and directly inserted into the vein. In this technique, there is no need to draw blood into a syringe to confirm that the needle is in the vein.
The aim of our study is to compare two ultrasound-guided techniques in terms of procedure time, number of attempts, and complication rates. We expect the syringe-free technique to have a shorter procedure time, fewer attempts, and a lower complication rate.
Materials and Methods Section:
The study was designed as a prospective, randomized, and single-blind study. Patients aged 18-85 years with an indication for central venous catheterization will be included in the study. Informed consent will be obtained from patients who will undergo surgery under general anesthesia before the anesthesia procedure.
Patients included in the study will be divided into two groups using computer-assisted randomization.
Patients in the first group will undergo central catheterization of the jugular vein using the Seldinger method (first inserting a guide wire and then inserting the catheter) with ultrasound guidance using an out-of-plane technique.
In the second group of patients, central jugular vein catheterization will be performed using the Seldinger method (with a guide wire) with in-plane technique (longitudinal visualization of the entire needle and vessel) under ultrasound guidance. A linear ultrasound probe will be used in both groups of patients during the procedure. The number of needle insertions, needle placements, number of attempts, and procedure time will be recorded and compared for both groups. In addition, rare complications such as bleeding, hemothorax, pneumothorax, hematoma, and carotid artery injury will be recorded. The ease of the procedure will be scored by the practitioner on a scale of 0 to 10 (0: most difficult, 10: easiest). The appearance of the needle, vessels, guide wire, and catheter on ultrasound will also be scored and recorded on a scale of 1 to 5 (very difficult: 1, difficult: 2, moderate: 3, easy appearance: 4, excellent: 5).
The recorded data will be compared between the two groups.
Inclusion Criteria:
Patients aged 18-85 years with indications for central venous catheterization in the operating room.
Exclusion Criteria:
Morbidly obese patients (BMI >40) Patients with severe coagulopathy Patients with severe neck deformity Patients with skin deformity or infection at the catheterization site Patients with congenital anomalies in the central veins
Sample Selection:
Considering previous studies on this subject, a total of 80 patients in both groups are needed to shorten the procedure time by 30%. Considering patients who may be excluded from the study, a total of 90 patients were planned to be included (α: 0.05, power 90%).
Statistical Method to be Used:
Continuous quantitative data will be presented as number, mean ± standard deviation. Qualitative variables will be expressed as median, 25th and 75th percentiles. Continuous variables with independent measurements and a normal distribution will be analyzed using the T-test. For data that do not show a normal distribution, the Mann-Whitney test will be applied. Chi-square tests will be applied to categorical data, and p <0.05 will be considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| with a syringe | Experimental | Procedure: out-of-plane techniqueCentral catheterization of the jugular vein will be performed using the Seldinger method (first inserting a guide wire, then placing the catheter over it) with ultrasound guidance and an out-of-plane technique. A guide needle attached to a syringe will be inserted into the vein to aspirate blood, and then a catheter will be placed over the wire sent into the vein through the needle. This procedure will be performed under ultrasound guidance, visualizing the veins, guide wire, and needle. |
| syringe-free technique | Active comparator | Procedure: in-plane techniqueIn the syringe-free technique, a guide wire will be placed inside the needle and sent directly into the vein. In this technique, central jugular vein catheterization will be performed using the Seldinger method (using a guide wire) with an in-plane approach (visualizing the entire needle and vein longitudinally). There is no need to draw blood into a syringe to confirm that the needle is in the vein. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients aged 18-85 years who have an indication for central venous catheterization in the operating room.
Key exclusion criteria (5 listed)
- Morbidly obese patients (body mass index >40)
- Those with severe coagulopathy
- Severe neck deformity
- Skin deformity or infection at the catheterization site
- Those with congenital anomalies in the central veins
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 |
|---|---|---|
| out-of-plane techniqueultrasound-guided out-of-plane technique for central venous catheterization | Procedure or surgery | with a syringe |
| in-plane techniqueIn the syringe-free technique, a guide wire is placed inside the needle and sent directly into the vein. In this technique, there is no need to draw blood into the syringe to confirm its presence in the vein. Using ultrasound-guided in-plane technique (with the entire needle and vein visualized longitudinally), central catheterization of the jugular vein will be performed using the Seldinger method (with a guide wire). | Procedure or surgery | syringe-free technique |
Primary outcome
processing time
Time frame: The procedure time is expected to be 30% shorter with the syringe-free technique. Catheter insertion is expected to take around 120 seconds.
The technique to be used will be determined according to the randomization performed. The procedure time will begin at the moment of the first needle insertion (syringe or catheter needle) after skin cleansing and will end at the placement of the jugular catheter without suturing.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2026.
- Background: PubMed 32174238Balaban O, Turgut M, Aydin T. Ultrasound-guided supraclavicular brachiocephalic vein catheterization in children: Syringe-free in-plane technique with micro-convex probe. J Vasc Access. 2020 Mar;21(2):241-245. doi: 10.1177/1129729819867221. Epub 2019 Sep 6.
- Individual participant dataSharing planned: Yes. Patient demographic data Study protocol Statistical analysis data
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.
Onur Balaban, medical doctor contact
Questions about this trial
What is this clinical trial studying?
A study testing out-of-plane technique and in-plane technique in people with Central Venous Catheters/Standards and Ultrasonography/Methods, run by ALİEMAN.
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 5 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: opening soon, as of the sponsor's last update on 23 Apr 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ali Eman (+905325152816 ext. medical doctor, dralieman02@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
processing time (time frame: The procedure time is expected to be 30% shorter with the syringe-free technique. Catheter insertion is expected to take around 120 seconds.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07547397, which also lists 1 linked publication.
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 23 Apr 2026; AzTrials last refreshed its copy on 7 Nov 2026.