Ultrasound-guided Subclavian Vein Catheterisation With a Needle Guide

NCT05513378 | Completed

• 1 other identifier: ELUSIVE
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Complications; Catheter, Mechanical; Catheterization, Central Venous

Keywords

diagnostic imaging

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• The frequency of mechanical complications

  24 hours after the completion of the central venous catheterization

• Needle visibility

  During the central venous catheterization, up to 4 hours after inclusion

• Time to successful vessel puncture

  During the central venous catheterization, up to 4 hours after inclusion

• The number of needle redirections

  During the central venous catheterization, up to 4 hours after inclusion

• The number of failed catheterizations

  During the central venous catheterization, up to 4 hours after inclusion

Study Arms (2)

With Needle Guide

EXPERIMENTAL

A needle guide adapted to a micro-convex ultrasound probe will be used in ultrasound-guided catheterisation of the subclavian vein using the long-axis approach with an in-plane needling technique

Device: Needle guide

Without Needle Guide

NO INTERVENTION

A micro-convex ultrasound probe without needle guide will be used in ultrasound-guided catheterisation of the subclavian vein using the long-axis approach with an in-plane needling technique

Interventions

Needle guide DEVICE

Please see the arm/group description

Also known as: The Ultra-Pro II™ Needle Guide, model C8-5 Philips

With Needle Guide

Eligibility Criteria

• Age: 18 Years - 105 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Thomas Kander: lead

Study Sites (1)

Intensive and Perioperative Care. Skåne University Hospital. Lund

Lund, Skåne County, 22185, Sweden

Location

Related Publications (1)

• Naddi L, Borgquist O, Adrian M, Bark BP, Kander T. Ultrasound-guided subclavian vein catheterisation with a needle guide (ELUSIVE): protocol for a randomised controlled study. BMJ Open. 2023 Dec 19;13(12):e080515. doi: 10.1136/bmjopen-2023-080515.

  PMID: 38114277 DERIVED

Study Officials

• Thomas Kander, Assoc. Prof.

  Region Skåne and Lund University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The researcher who will review the documented ultrasound movies and assess the secondary outcomes will be blinded. However, given the nature of the study neither the Care Provider or Investigators will be blinded for the group affiliation or the primary outcome
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor and Sponsor Investigator

Study Record Dates

• First Submitted: August 21, 2022
• First Posted: August 24, 2022
• Study Start: November 8, 2022
• Primary Completion: September 16, 2025
• Study Completion: September 30, 2025
• Last Updated: October 6, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: Data will be available beginning 3 months and ending 5 years following article publication.
• Access Criteria: Access will be given to researchers who provide a methodologically sound proposal. Proposals should be directed to the research group Clinical Research in Anaesthesia and Intensive Care Medicine, C/O Thomas Kander, Dept. of Clinical Sciences, Lund, Lund University, Sweden. To gain access, data requestors will need to sign a data access agreement.

Locations

SE (1)