Skip to main content
OpenTrials
Completed

NCT Number: NCT03077802

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).

Completed

Looking for future studies?

Notify Me

Key information

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Seoul National University Hospital

Seoul, 03080, South Korea

About this study

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hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn.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 The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel.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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Modified Seldinger technique, Experienced group

Other

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.

Seldinger technique, Experienced group

Other

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.

Modified Seldinger technique, Inexperienced group

Other

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.

Seldinger technique, Inexperienced group

Other

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.

Long-axis technique

Other

Ultrasound probe is placed parallel to the vessel trajectories and needle is advanced using in-plane approach.

Short-axis technique

Other

Ultrasound probe is placed vertical to the vessel trajectories and needle is advanced using out-of-plane approach.

Primary outcomes

  1. 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)

Secondary outcomes

  1. incidence of arterial puncture

    Time frame: 5 min after internal jugular vein catheterization

    incidence of arterial puncture during internal jugular vein catheterization

  2. incidence of local hematoma

    Time frame: 5 min after internal jugular vein catheterization

    incidence of jugular venous hematoma during internal jugular vein catheterization

  3. incidence of pneumothorax

    Time frame: 5 min after internal jugular vein catheterization

    incidence of pneumothorax during internal jugular vein

  4. incidence of hemothorax

    Time frame: 5 min after internal jugular vein catheterization

    incidence of hemothorax during internal jugular vein

  5. 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)

  6. number of attempts of needle advance

    Time frame: 5 min after internal jugular vein catheterization

    number of attempts of needle advance

  7. 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)

  8. 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)

  9. 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

  10. 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

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2019
Study completion
2019
First posted
Mar 13, 2017
Registry last updated
Dec 12, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.