Wire-in-needle vs. Traditional Technique for Ultrasound-guided Central Venous Catheter Placement

NCT05452590 | Completed

• 1 other identifier: 2022-100852-BO-ff
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

Central venous catheters (CVC) are commonly inserted in surgical or critically ill patients. However, CVC placement can cause severe complications. To reduce the incidence of complications and increase procedural safety and quality, ultrasound (US)-guided CVC insertion is recommended by various scientific societies, including the American Society of Anesthesiologists. During conventional US-guided CVC placement, the correct position of the needle tip in the venous vessel is confirmed by direct US visualization and aspiration of blood using a syringe connected to the needle. After blood aspiration, the operator must discontinue US-guidance to disconnect the syringe and the needle and to pass the guidewire through the needle (without direct US visualization). This step bears the risks of dislocating the needle tip and puncturing the posterior wall of the target vein or an adjacent artery. Some authors thus propose an US-guided wire-in-needle technique - in which the guidewire is directly adapted to the needle (without a syringe) from the beginning of the procedure and the guidewire is advanced under direct US visualization. Whether the wire-in-needle technique decreases the procedure time, the number of needle passes, and complications compared to conventional US-guided CVC remains scarcely investigated. We thus propose a randomized controlled trial to investigate whether the US-guided wire-in-needle technique for CVC placement in the internal jugular vein (IJV) is faster and safer than the conventional US-guided technique in patients having cardiac surgery.

Conditions

Central Venous Catheter Placement

Outcome Measures

Primary Outcomes (1)

• Time between skin puncture and removal of the needle during placement of the first guidewire.

  Time between skin puncture and removal of the needle during placement of the first guidewire in seconds.

  From the beginning of central venous catheter placement till the end of central venous catheter placement.

Secondary Outcomes (6)

• Complications

  From the beginning of central venous catheter placement till the end of central venous catheter placement.

• Complications

  From the beginning of central venous catheter placement till the end of central venous catheter placement.

• Complications

  From the beginning of central venous catheter placement till the end of central venous catheter placement.

• Number of needle passes

  From the beginning of central venous catheter placement till the end of central venous catheter placement.

• Number of skin punctures

  From the beginning of central venous catheter placement till the end of central venous catheter placement.

Study Arms (2)

Ultrasound-guided wire-in-needle technique

EXPERIMENTAL

The guidewire will be connected to the needle. The IJV will be punctured in a long-axis in-plane approach. When the needle tip enters the IJV, the guidewire will be advanced through the needle into the IJV under continuous ultrasound visualization. The needle will then be removed. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view. Afterwards, the second guidewire will be placed in the same IJV approximately 1-2 centimeters distal to the fist guidewire using the same technique. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view again.

Procedure: Ultrasound-guided wire-in-needle technique for central venous catheter placement

Traditional technique

NO INTERVENTION

A syringe will be connected to the needle. The IJV will be punctured in a long-axis in-plane or short-axis out-of-plane approach (as preferred by the anesthesiologist). When the needle tip enters the IJV, blood is aspirated using the syringe. The operator will then discontinue US-guidance, disconnect the syringe and advance the guidewire through the needle into the IJV. The needle will then be removed. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view. Afterwards, the second guidewire will be placed in the same IJV approximately 1-2 centimeters distal to the fist guidewire using the same technique. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view again.

Interventions

Ultrasound-guided wire-in-needle technique for central venous catheter placement PROCEDURE

The guidewire will be connected to the needle. The IJV will be punctured in a long-axis in-plane approach. When the needle tip enters the IJV, the guidewire will be advanced through the needle into the IJV under continuous ultrasound visualization. The needle will then be removed. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view. Afterwards, the second guidewire will be placed in the same IJV approximately 1-2 centimeters distal to the fist guidewire using the same technique. The correct guidewire position in the IJV will be confirmed in the long-axis and short-axis view again.

Ultrasound-guided wire-in-needle technique

Eligibility Criteria

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

You may qualify if:

• patients scheduled for elective cardiac surgery at the University Heart Center Hamburg-Eppendorf in whom CVC placement and sheath introducer central line placement in the internal jugular vein is indicated for clinical reasons unrelated to the study
• age \> 18 years
• Written informed consent

You may not qualify if:

• longitudinal (long axis) view cannot be performed because of anatomical reasons (e.g., short neck).

Sponsors & Collaborators

• Universitätsklinikum Hamburg-Eppendorf: lead

Study Sites (1)

University Medical Center Hamburg-Eppendorf

Hamburg, 20251, Germany

Location

MeSH Terms

Interventions

Central Venous Catheters

Intervention Hierarchy (Ancestors)

Vascular Access Devices; Catheters; Equipment and Supplies

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 6, 2022
• First Posted: July 11, 2022
• Study Start: July 6, 2022
• Primary Completion: June 13, 2023
• Study Completion: September 25, 2023
• Last Updated: November 18, 2023

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)