Ultrasound-guided Subclavian Vein Catheterisation With a Needle Guide

Catheterization, Central Venous Clinical Trial

— ELUSIVE  

Official title:

A Randomized Controlled Trial Comparing In-line Ultrasound Guided Subclavian Vein Catheterization With or Without Needle Guide.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05513378
• Other study ID #: ELUSIVE
• Status: Recruiting
• Phase: N/A
• Start date: November 8, 2022
• Est. completion date: June 30, 2025

Study information

• Verified date: November 2023
• Source: Region Skane
• Contact: Thomas Kander, Assoc. Prof.
• Phone: +46 46 171163
• Email: thomas.kander[@]med.lu.se
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

OBJECTIVES The primary objective is to compare if the addition of a needle guide can reduce the number of central venous catheter (CVC) insertions with >1 skin puncture in ultrasound-guided catheterization of the subclavian vein using the long-axis approach with an in-plane needling technique. Secondary objectives include if this addition 1) decreases the frequency of mechanical complications (defined as bleeding, arterial puncture, arterial catheterization, nerve injury, pneumothorax), 2) increases the time when the needle is visible, 3) decreases the time until successful vessel punction, 4) decreases the number of needle redirections during the insertion, and 5) a comparison between the two groups regarding number of failed catheterizations. DESIGN This is a prospective, randomised, controlled, parallel intervention study. Patients will be enrolled at Skåne University Hospital in Lund, Sweden. The trial is investigator-initiated and non-commercial. POPULATION AND INTERVENTION Adults (18 years of age or older) in need of a subclavian CVC for any reason and able to give written informed consent will be included in the study provided no exclusion criteria is fulfilled. OUTCOMES Primary outcome will be number of CVC insertions with >1 skin puncture. Secondary outcomes include comparison between the two groups regarding 1) the frequency of mechanical complications, 2) proportion of the insertion-time when the needle is visible on the ultrasound (US) screen, 3) time to successful vessel punction, 4) the number of needle redirections during the insertion, 5) number of failed catheterisations, 6) Feasibility of the needle guide evaluated with a questionair to the operators at the end of the study.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: June 30, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 105 Years

Eligibility

Inclusion Criteria:

• Patients in need of a central venous catheter .
• Clinical indication for the subclavian route which includes expected time of use >5 days.
• Signed informed consent.

Exclusion Criteria:

• Patient is deemed unsuitable for cannulation of the subclavian vein, based on a pre-procedural US examination by the operator, or due to unacceptable patient risk in case of mechanical complication (e.g., severe respiratory failure).

Related Conditions & MeSH terms

• Catheterization, Central Venous

Intervention

Device:
• Needle guide
Please see the arm/group description

Locations

Country	Name	City	State
Sweden	Intensive and Perioperative Care. Skåne University Hospital. Lund	Lund	Skåne

Sponsors (1)

Lead Sponsor	Collaborator
Thomas Kander

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of subclavian catheter insertions with >1 skin puncture	Number of subclavian catheter insertions with >1 skin puncture	During the central venous catheterization, up to 3 hours after inclusion
Secondary	The frequency of mechanical complications	Mechanical complication include: 1) Bleeding World Health Organization (WHO)-grade 2-4. 2) Pneumothorax visible on post-procedural Xray. 3) Permanent nerve injury. 4) Arrhythmia WHO-grade 3 and 4. 5) Arterial catheterization	24 hours after the completion of the central venous catheterization
Secondary	Needle visibility	Proportion of the insertion-time when the needle is visible on the ultrasound screen	During the central venous catheterization, up to 4 hours after inclusion
Secondary	Time to successful vessel puncture	Time to successful vessel puncture	During the central venous catheterization, up to 4 hours after inclusion
Secondary	The number of needle redirections	The number of needle redirections during the insertion	During the central venous catheterization, up to 4 hours after inclusion
Secondary	The number of failed catheterizations	The number of failed catheterizations in the attempted subclavian vein	During the central venous catheterization, up to 4 hours after inclusion
Secondary	Feasibility of the needle guide	Feasibility of the needle guide by means of a questionnaire at the end of the study period.	Through the study period, anticipated 3 years