Echogenic Versus Non-echogenic Needles for Venous Access

Study Overview
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Brief Summary
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Randomized controlled intervention study comparing echogenic needles with non echogenic needles for ultrasound guided venous access in the subclavian vein.

Detailed Description
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Patients undergoing certain surgical procedures and patients in intensive care unit require a central venous catheter (CVC) for infusion of medicaments and for monitoring. Central venous access (CVA) can be performed both with a blind technique or an ultrasound guided technique. A common place for CVA is the subclavian vein. While many guidelines recommend the use of ultrasound for jugular access, there are no explicit recommendations for subclavian CVA For ultrasound guided CVA procedures good needle visualization is important to successfully place the needle and catheter in the correct position. Echogenic needles can give better needle visualization when performing ultrasound guided CVA procedures. Theoretically, the use of echogenic needles should improve performance time and success rates, and reduce complication rates due to a better needling control. The investigators will investigate the use of echogenic needles for vascular access. A prospective randomized controlled trial design will be used. Echogenic needles will be compared with non-echogenic (standard) needles. The main null hypothesis states that there is no difference in access time between the needles.

Official Title
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Ultrasound Guided Subclavian Vein Cannulation. Echogenic Needles Versus Non-echogenic Needles

Conditions
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Anesthesia, Vascular Access Complication

Intervention / Treatment
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* Device: echogenic needles for intravenous access


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: undergoing a surgical procedure requiring a CVC Patients must be at least 18 years of age. Patients that have given informed written consent. - Exclusion Criteria: Patients that do not speak or understand Norwegian language. Skin disease or infection affecting the whole-body surface or within the area of examination. Patients with untreated coagulopathy Known vascular abnormality Any reason why, in the opinion of the investigators, the patient should not participate. Subject participates in a potentially confounding drug or device trial during the course of the study.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Two arms Venous access either with echogenic needles or with non-echogenic needles
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Echogenic needle<br>venous access performed under ultrasound guidance with echogenic needles | Device: echogenic needles for intravenous access<br>* echogenic needles for intravenous access (subclavian vein) ultrasound guided procedure<br>|
| No Intervention: Non-Echogenic needles<br>venous access performed under ultrasound guidance with non-echogenic needles | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from skin puncture of the needle until aspiration of venous blood. | Time from skin puncture of the needle until aspiration of venous blood in the syringe. Time till venous access | 10 sec - 240 sec | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from skin puncture until catheter in place | Time from skin puncture until the catheter in place in the subclavian vein. | 60 sec - 600 sec | 
| Success with venous access in first needling attempt | Success in first attempt is defined as one skin puncture and directly into the subclavian vein | 60 sec - 600 sec | 
| Number of needling attempts before venous access | Number of attempts is defined as the counted number of needle attempts intermitted by a needle withdrawal of at least 0.5 cm until aspiration of venous blood. | 60 sec - 600 sec | 
| Number of skin punctures | Number of skin punctures is defined as the counted number of skin punctures until aspiration of venous blood. | 60 sec - 600 sec | 
| The procedure was aborted | Discontinuation of the procedure or change of site for vascular access | 2 minutes - 20 minutes | 
| Localization of catheter tip in x-ray | Catheter misplacement judged by x-ray. X-ray will be performed after the surgery and a blinded observer will describe the localization of the catheter. | 1 day- 7 days | 
| The anaesthetists subjective experience with needle visualization | After performing the vascular access the anaesthetists are asked about how they found the visualization of the needle using a Numeric Rating Scale | 3 min- 20 min | 
| The anaesthetists subjective experience with the needle placement | After performing the vascular access the anaesthetist is asked how the needle placement was using a Numeric Rating Scale | 3 minutes - 20 minutes | 
| Adverse events during the procedure | Adverse events, including information of the seriousness, treatment needed, resolution and relevant judgment concerning the causal relationship with the investigational devices or procedure will be summarized for safety information | 1 minutes- 1 day | 
| Adverse effects after the procedure | Adverse device effects, including information of the seriousness, treatment needed, resolution and relevant judgment concerning the causal relationship with the investigational devices or procedure will be summarized | 5 minutes - 1 week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vascular access,, ultrasound guided, echogenic needles