- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07547397
COMPARISON OF CLASSICAL AND SYRINGE-FREE TECHNIQUES IN ULTRASOUND-GUIDED CENTRAL JUGULAR VENOUS CATHETERIZATION (syringe-free)
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
Intervention / Treatment
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
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Ali Eman
- Phone Number: medical doctor +905325152816
- Email: dralieman02@gmail.com
Study Contact Backup
- Name: Onur Balaban, medical doctor
- Phone Number: +905327000691
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
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
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
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.
|
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.
|
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
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
Sponsor
Publications and helpful links
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
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- balaban jugular catheter
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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