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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03077802
Recruitment Status : Completed
First Posted : March 13, 2017
Last Update Posted : December 12, 2019
Sponsor:
Information provided by (Responsible Party):
Won Ho Kim, MD, Seoul National University Hospital

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).

Condition or disease Intervention/treatment Phase
Catheterization, Central Venous Other: Modified Seldinger technique, Experienced group Other: Seldinger technique, Experienced group Other: Modified Seldinger technique, Inexperienced group Other: Seldinger technique, Inexperienced group Other: Long-axis technique Other: Short-axis technique Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 308 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: randomized controlled trial
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Other
Official Title: Comparison of Two Needle Insertion Techniques on Success Rate and Complications During Ultrasound Guided Central Venous Catheterization: Seldinger vs. Modified Seldinger Technique
Actual Study Start Date : October 2015
Actual Primary Completion Date : February 28, 2019
Actual Study Completion Date : February 28, 2019

Arm Intervention/treatment
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: 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.

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.

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: 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.

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, 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: 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.

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.




Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03077802


Locations
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Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Sponsors and Collaborators
Seoul National University Hospital

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Responsible Party: Won Ho Kim, MD, Clinical Associate Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT03077802    
Other Study ID Numbers: 1506-126-684
First Posted: March 13, 2017    Key Record Dates
Last Update Posted: December 12, 2019
Last Verified: December 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Won Ho Kim, MD, Seoul National University Hospital:
Seldinger technique
Modified Seldinger technique
Complication
Success rate