Ultrasound-guided Subclavian Vein Catheterisation With a Needle Guide (ELUSIVE)

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

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.

Study Overview

• Status: Recruiting
• Conditions: Catheterization, Central Venous; Complications; Catheter, Mechanical
• Intervention / Treatment: Device: Needle guide

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Thomas Kander, Assoc. Prof.; Phone Number: +46 46 171163; Email: thomas.kander@med.lu.se
• Study Contact Backup: Name: Leila Naddi, MD; Phone Number: +46 46 17 36 99; Email: leila.naddi@med.lu.se

Study Locations

• Sweden
  • Skåne
    • Lund, Skåne, Sweden, 22185
      • Recruiting
      • Intensive and Perioperative Care. Skåne University Hospital. Lund
      • Contact: Leila Naddi, MD; Phone Number: +46 46 17 36 99; Email: leila.naddi@med.lu.se
      • Contact: Thomas Kander, Ass. Prof.; Phone Number: +46 46 17 11 63; Email: thomas.kander@med.lu.se

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 105 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: With Needle Guide; 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; Please see the arm/group description; Other Names: The Ultra-Pro II™ Needle Guide, model C8-5 Philips
No Intervention: Without Needle Guide; 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Time to successful vessel puncture	Time to successful vessel puncture	During the central venous catheterization, up to 4 hours after inclusion
The number of needle redirections	The number of needle redirections during the insertion	During the central venous catheterization, up to 4 hours after inclusion
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
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

Collaborators and Investigators

• Sponsor: Thomas Kander
• Investigators: Principal Investigator: Thomas Kander, Assoc. Prof., Region Skane and Lund University

Study record dates

Study Major Dates

• Study Start (Actual): November 8, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 21, 2022
• First Submitted That Met QC Criteria: August 23, 2022
• First Posted (Actual): August 24, 2022

Study Record Updates

• Last Update Posted (Actual): November 8, 2023
• Last Update Submitted That Met QC Criteria: November 5, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Keywords: diagnostic imaging
• Other Study ID Numbers: ELUSIVE

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data that underlie the results reported in this study, will be made available on reasonable request and after deidentification.
• IPD Sharing Time Frame: Data will be available beginning 3 months and ending 5 years following article publication.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No