Ultrasound-guided Subclavian Vein Catheterisation With a Needle Guide

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

300 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-11-08

Study Completion Date

2025-09-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Complications; Catheter, Mechanical Catheterization, Central Venous

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

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

Study Groups

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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

Group Type EXPERIMENTAL

Needle guide

Intervention Type DEVICE

Please see the arm/group description

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Needle guide

Please see the arm/group description

Intervention Type DEVICE

Other Intervention Names

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The Ultra-Pro II™ Needle Guide, model C8-5 Philips

Eligibility Criteria

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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).

Minimum Eligible Age

18 Years

Maximum Eligible Age

105 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No