Ultrasound-guided Subclavian Vein Catheterisation With a Needle Guide

Study Overview
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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.

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

Conditions
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Complications; Catheter, Mechanical, Catheterization, Central Venous

Intervention / Treatment
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* Device: Needle guide


Participation Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 105 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diagnostic imaging