Ultrasound-guided Subclavian Vein Catheterisation With a Needle Guide

Not Applicable

Recruiting

• Conditions: Catheterization, Central Venous; Complications; Catheter, Mechanical
• Interventions: Device: Needle guide

• Registration Number: NCT05513378
• Lead Sponsor: Thomas Kander

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-21
• Study First Submitted QC: 2022-08-23
• Study First Posted: 2022-08-24
• Study Start: 2022-11-08
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-02
• Last Update Posted: 2025-04-06
• Primary Completion: 2025-09-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 300

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With Needle Guide	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

Primary Outcome Measures

Name	Time	Method
Number of subclavian catheter insertions with >1 skin puncture	During the central venous catheterization, up to 3 hours after inclusion	Number of subclavian catheter insertions with \>1 skin puncture

Secondary Outcome Measures

Name	Time	Method
Time to successful vessel puncture	During the central venous catheterization, up to 4 hours after inclusion	Time to successful vessel puncture
The number of failed catheterizations	During the central venous catheterization, up to 4 hours after inclusion	The number of failed catheterizations in the attempted subclavian vein
Feasibility of the needle guide	Through the study period, anticipated 3 years	Feasibility of the needle guide by means of a questionnaire at the end of the study period.
Needle visibility	During the central venous catheterization, up to 4 hours after inclusion	Proportion of the insertion-time when the needle is visible on the ultrasound screen
The frequency of mechanical complications	24 hours after the completion of the central venous catheterization	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
The number of needle redirections	During the central venous catheterization, up to 4 hours after inclusion	The number of needle redirections during the insertion

Trial Locations

Locations (1)

Intensive and Perioperative Care. Skåne University Hospital. Lund; 🇸🇪 Lund, Skåne, Sweden