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

NCT03077802 | Completed

• 1 other identifier: 1506-126-684
• Study Type: interventional
• Target: 308
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Catheterization, Central Venous

Keywords

Seldinger technique; Modified Seldinger technique; Complication; Success rate

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• incidence of arterial puncture

  5 min after internal jugular vein catheterization

• incidence of local hematoma

  5 min after internal jugular vein catheterization

• incidence of pneumothorax

  5 min after internal jugular vein catheterization

• incidence of hemothorax

  5 min after internal jugular vein catheterization

• Time to successful jugular venous catheterization

  5 min after internal jugular vein catheterization

Study Arms (4)

Modified Seldinger technique, Experienced group

EXPERIMENTAL

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 The needle is withdrawn, guidewire is advanced through the guiding sheath, central catheter is placed into the vessel.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; Other: Long-axis technique; Other: Short-axis technique

Seldinger technique, Experienced group

ACTIVE COMPARATOR

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hollow needle, syringe is detached and guidewire is advanced through the lumen of the needle, and then the needle is withdrawn.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: Seldinger technique, Experienced group; Other: Long-axis technique; Other: Short-axis technique

Modified Seldinger technique, Inexperienced group

EXPERIMENTAL

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: Modified Seldinger technique, Inexperienced group; Other: Long-axis technique; Other: Short-axis technique

Seldinger technique, Inexperienced group

ACTIVE COMPARATOR

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: Seldinger technique, Inexperienced group; Other: Long-axis technique; Other: Short-axis technique

Interventions

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.

Modified Seldinger technique, Experienced group

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.

Seldinger technique, Experienced group

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.

Modified Seldinger technique, Inexperienced group

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.

Seldinger technique, Inexperienced group

Long-axis technique OTHER

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

Modified Seldinger technique, Experienced group; Modified Seldinger technique, Inexperienced group; Seldinger technique, Experienced group; Seldinger technique, Inexperienced group

Short-axis technique OTHER

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

Modified Seldinger technique, Experienced group; Modified Seldinger technique, Inexperienced group; Seldinger technique, Experienced group; Seldinger technique, Inexperienced group

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patient scheduled for surgery and internal jugular vein central catheterization

You may not qualify if:

• 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

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Related Publications (1)

• Yoon HK, Hur M, Cho H, Jeong YH, Lee HJ, Yang SM, Kim WH. Effects of practitioner's experience on the clinical performance of ultrasound-guided central venous catheterization: a randomized trial. Sci Rep. 2021 Mar 24;11(1):6726. doi: 10.1038/s41598-021-86322-y.

  PMID: 33762662 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Associate Professor

Model Details: randomized controlled trial

Study Record Dates

• First Submitted: March 8, 2017
• First Posted: March 13, 2017
• Study Start: October 1, 2015
• Primary Completion: February 28, 2019
• Study Completion: February 28, 2019
• Last Updated: December 12, 2019

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)