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

Catheterization, Central Venous Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03077802
• Other study ID #: 1506-126-684
• Status: Completed
• Phase: N/A
• Start date: October 2015
• Est. completion date: February 28, 2019

Study information

• Verified date: December 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

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hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn.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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 308
• Est. completion date: February 28, 2019
• Est. primary completion date: February 28, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Catheterization, Central Venous

Intervention

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.
• 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.
• 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.
• 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.
• Long-axis technique
Ultrasound probe is placed parallel to the vessel trajectories and needle is advanced using in-plane approach.
• Short-axis technique
Ultrasound probe is placed vertical to the vessel trajectories and needle is advanced using out-of-plane approach.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of attempts of needle advance for successful venous puncture	number of attempts of needle advance (number of needling attempt)	5 min after internal jugular vein catheterization
Secondary	incidence of arterial puncture	incidence of arterial puncture during internal jugular vein catheterization	5 min after internal jugular vein catheterization
Secondary	incidence of local hematoma	incidence of jugular venous hematoma during internal jugular vein catheterization	5 min after internal jugular vein catheterization
Secondary	incidence of pneumothorax	incidence of pneumothorax during internal jugular vein	5 min after internal jugular vein catheterization
Secondary	incidence of hemothorax	incidence of hemothorax during internal jugular vein	5 min after internal jugular vein catheterization
Secondary	Time to successful jugular venous catheterization	incidence of hemothorax during internal jugular vein (overall procedure time)	5 min after internal jugular vein catheterization
Secondary	number of attempts of needle advance	number of attempts of needle advance	5 min after internal jugular vein catheterization
Secondary	number of attempts of catheter advance	number of attempts of needle advance (only in modified Seldinger group)	5 min after internal jugular vein catheterization
Secondary	incidence of successful central venous 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
Secondary	grade of resistance during dilator insertion	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
Secondary	number of attempts of guidewire advance	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