COMPARISON OF CLASSICAL AND SYRINGE-FREE TECHNIQUES IN ULTRASOUND-GUIDED CENTRAL JUGULAR VENOUS CATHETERIZATION (syringe-free)

April 17, 2026 updated by: ALİEMAN

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

  • Name: Onur Balaban, medical doctor
  • Phone Number: +905327000691

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients aged 18-85 years who have an indication for central venous catheterization in the operating room.

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: with a syringe
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.
Procedure: out-of-plane technique
ultrasound-guided out-of-plane technique for central venous catheterization
Active Comparator: syringe-free technique
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.
Procedure: in-plane technique
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).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
The procedure time is expected to be 30% shorter with the syringe-free technique. Catheter insertion is expected to take around 120 seconds.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ALİEMAN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

  • 5. Balaban, O., Turgut, M., & Aydın, T. (2020). Ultrasound-guided supraclavicular brachiocephalic vein catheterization in children: Syringe-free in-plane technique with micro-convex probe. The journal of vascular access, 21(2), 241-245. https://doi.org/10.1177/1129729819867221

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 30, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 17, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 23, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 17, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • balaban jugular catheter

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Patient demographic data Study protocol Statistical analysis data

IPD Sharing Time Frame

Sonuçların yayınlanmasından 3 ay sonra başlayıp 3 yıl sonra sona eren dönem

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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