Ultrasound Guided Central Venous Catheterization: Seldinger vs. Modified Seldinger Technique

December 9, 2019 updated by: Won Ho Kim, MD, Seoul National University Hospital

Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Ultrasound Guided Central Venous Catheterization: Seldinger vs. Modified Seldinger Technique

The investigators intend to compare the Seldinger technique and modified Seldinger technique on success rate and complications during central venous catheterization by a prospective, randomized, controlled study. The investigators are planning to compare both techniques in both experienced (anesthesiologist board member) and non-experienced practitioners (first and second-grade resident).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

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

Unintended arterial puncture and local hematoma formation are the most common complications during internal jugular vein central venous catheterization. Other serious complications like pseudoaneurysm, arteriovenous fistula, arterial dissection, thrombosis, embolism are also possible. These complications mostly occur by mechanical trauma or injury when advancing needle back and forth to puncture internal jugular vein. Placement of guidewire or dilator can also cause mechanical trauma or injury around the vessel.

Because internal jugular vein collapses easily during needle advance, anterior and posterior wall of the vessel can be punctured simultaneously. Posterior wall puncture can increase the risk of complications of the catheterization. Delicate puncture of the vessel and stable fixation of the needle after puncture are important to reduce overall number of catheterization attempts, increase success rate, reduce complications.

Seldinger technique(thin-wall needle technique) is commonly used procedure to obtain safe access to central vein. The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. Contrarily, modified Seldinger technique(guiding sheath-over-the-needle technique) use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel.

When using Seldinger technique, it is important to fix the needle firmly with hand until the guidewire is placed into the vessel lumen. If hand fixation is not stable, needle tip can migrate from the lumen, can pierce the vessel wall, and carotid artery puncture, and local hematoma formation might occur. Even if there is no evidence of complications, when blood regurgitation fails, overall number of vessel puncture attempts would increase and it is expected that rate of complications of the catheterization would increase.

When using modified Seldinger technique, guiding sheath is easily slid over the needle, providing stable route into the vessel lumen relatively in early step of the catheterization. Therefore, it is expected that stability of the fixation improves, success rate of the catheterization increase, and complications of the catheterization decrease. But there is no high level of evidence yet, and still decision to use which technique is based on experience of the operator.

The investigators are going to compare the Seldinger technique and modified Seldinger technique on success rate and complications during central venous catheterization by prospective, randomized, controlled study.

In addition, any difference in success rate and complications between the two techniques may be different depending on the experience of the practitioners. Therefore, the investigators also plan to compare the two techniques between experienced and non-experienced practitioners.

The success rate and complications between the two techniques may also be different depending on the long and short-axis techniques. As subgroup analyses, we intend to investigate whether there is a difference between Seldinger and modified Seldinger technique according to the experience of the operator or long or short axis approach.

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 (Actual)

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.
308

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 Locations

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

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • patient scheduled for surgery and internal jugular vein central catheterization

Exclusion Criteria:

  • Patient who doesn't agree to the study
  • Catheterization site inflammation
  • Contralateral diaphragmatic dysfunction
  • Anatomic anomalies of carotid artery or vein
  • Previous neck surgical history
  • Recent (less than 1 month) right internal jugular vein central catheterization

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: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

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: Modified Seldinger technique, Experienced group
Under ultrasound-guide, we will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. The procedure will be performed by experienced practitioner who were defined as board-certified anesthesiologist staffs and had experience of more than 50 central venous catheterizations in both techniques.
Other: Modified Seldinger technique, Experienced group
This is a technique for central venous catheterization. We will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. The procedure will be performed by experienced practitioners who are board-certified anesthesiologist staffs and have experience of more than 50 central venous catheterizations in both techniques.
Other: Long-axis technique
Ultrasound probe is placed parallel to the vessel trajectories and needle is advanced using in-plane approach.
Other: Short-axis technique
Ultrasound probe is placed vertical to the vessel trajectories and needle is advanced using out-of-plane approach.
Active Comparator: Seldinger technique, Experienced group
Under ultrasound-guide, the desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. The procedure will be performed by experienced practitioner who were defined as board-certified anesthesiologist staffs and had experience of more than 50 central venous catheterizations in both techniques.
Other: Long-axis technique
Ultrasound probe is placed parallel to the vessel trajectories and needle is advanced using in-plane approach.
Other: Short-axis technique
Ultrasound probe is placed vertical to the vessel trajectories and needle is advanced using out-of-plane approach.
Other: Seldinger technique, Experienced group
This is a technique for central venous catheterization. The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. The procedure will be performed by experienced practitioners who are board-certified anesthesiologist staffs and have experience of more than 50 central venous catheterizations in both techniques.
Experimental: Modified Seldinger technique, Inexperienced group
Under ultrasound-guide, we will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. The procedure will be performed by inexperienced practitioner who were junior residents and had experience of less than 50 central venous catheterizations in both techniques.
Other: Long-axis technique
Ultrasound probe is placed parallel to the vessel trajectories and needle is advanced using in-plane approach.
Other: Short-axis technique
Ultrasound probe is placed vertical to the vessel trajectories and needle is advanced using out-of-plane approach.
Other: Modified Seldinger technique, Inexperienced group
This is a technique for central venous catheterization. We will use needle that is covered with guiding sheath. After desired vessel puncture, guiding sheath is instantly slid over the needle into the vessel. The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel. This technique will be performed by inexperienced practitioners who are junior residents and have experience of less than 50 central venous catheterizations in both techniques.
Active Comparator: Seldinger technique, Inexperienced group
Under ultrasound-guide, the desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. The procedure will be performed by inexperienced practitioner who were junior residents and had experience of less than 50 central venous catheterizations in both techniques.
Other: Long-axis technique
Ultrasound probe is placed parallel to the vessel trajectories and needle is advanced using in-plane approach.
Other: Short-axis technique
Ultrasound probe is placed vertical to the vessel trajectories and needle is advanced using out-of-plane approach.
Other: Seldinger technique, Inexperienced group
This is a technique for central venous catheterization. The desired vessel is punctured with a sharp hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn. Central catheter is then passed over the guidewire into the vessel. This technique will be performed by inexperienced practitioners who are junior residents and have experience of less than 50 central venous catheterizations in both techniques.

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
number of attempts of needle advance for successful venous puncture
Time Frame: 5 min after internal jugular vein catheterization
number of attempts of needle advance (number of needling attempt)
5 min after internal jugular vein catheterization

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
incidence of arterial puncture
Time Frame: 5 min after internal jugular vein catheterization
incidence of arterial puncture during internal jugular vein catheterization
5 min after internal jugular vein catheterization
incidence of local hematoma
Time Frame: 5 min after internal jugular vein catheterization
incidence of jugular venous hematoma during internal jugular vein catheterization
5 min after internal jugular vein catheterization
incidence of pneumothorax
Time Frame: 5 min after internal jugular vein catheterization
incidence of pneumothorax during internal jugular vein
5 min after internal jugular vein catheterization
incidence of hemothorax
Time Frame: 5 min after internal jugular vein catheterization
incidence of hemothorax during internal jugular vein
5 min after internal jugular vein catheterization
Time to successful jugular venous catheterization
Time Frame: 5 min after internal jugular vein catheterization
incidence of hemothorax during internal jugular vein (overall procedure time)
5 min after internal jugular vein catheterization
number of attempts of needle advance
Time Frame: 5 min after internal jugular vein catheterization
number of attempts of needle advance
5 min after internal jugular vein catheterization
number of attempts of catheter advance
Time Frame: 5 min after internal jugular vein catheterization
number of attempts of needle advance (only in modified Seldinger group)
5 min after internal jugular vein catheterization
incidence of successful central venous catheterization
Time Frame: 5 min after internal jugular vein catheterization
incidence of successful central venous catheterization (success defined as completion of catheterization within three attempts of needle advance)
5 min after internal jugular vein catheterization
grade of resistance during dilator insertion
Time Frame: 5 min after internal jugular vein catheterization
grade of resistance during dilator insertion (grade 1: easy, grade 2: moderate, grade 3: difficult, use of blade for skin incision
5 min after internal jugular vein catheterization
number of attempts of guidewire advance
Time Frame: 5 min after internal jugular vein catheterization
number of attempts of guidewire advance through the lumen of needle or guidewire sheath after desired vessel is punctured
5 min after internal jugular vein catheterization

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.
Seoul National University Hospital

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

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 (Actual)

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.
October 1, 2015

Primary Completion (Actual)

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.
February 28, 2019

Study Completion (Actual)

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.
February 28, 2019

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).
March 8, 2017

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.
March 8, 2017

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.
March 13, 2017

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.
December 12, 2019

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.
December 9, 2019

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.
December 1, 2019

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.
  • 1506-126-684

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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