Echogenic Versus Non-echogenic Needles for Venous Access

Overview

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

Full Title of Study: “Ultrasound Guided Subclavian Vein Cannulation. Echogenic Needles Versus Non-echogenic Needles”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Supportive Care
    • Masking: Double (Participant, Outcomes Assessor)
  • Study Primary Completion Date: August 30, 2022

Detailed Description

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.

Interventions

  • Device: echogenic needles for intravenous access
    • echogenic needles for intravenous access (subclavian vein) ultrasound guided procedure

Arms, Groups and Cohorts

  • Active Comparator: Echogenic needle
    • venous access performed under ultrasound guidance with echogenic needles
  • No Intervention: Non-Echogenic needles
    • venous access performed under ultrasound guidance with non-echogenic needles

Clinical Trial Outcome Measures

Primary Measures

  • Time from skin puncture of the needle until aspiration of venous blood.
    • Time Frame: 10 sec – 240 sec
    • Time from skin puncture of the needle until aspiration of venous blood in the syringe. Time till venous access

Secondary Measures

  • Time from skin puncture until catheter in place
    • Time Frame: 60 sec – 600 sec
    • Time from skin puncture until the catheter in place in the subclavian vein.
  • Success with venous access in first needling attempt
    • Time Frame: 60 sec – 600 sec
    • Success in first attempt is defined as one skin puncture and directly into the subclavian vein
  • Number of needling attempts before venous access
    • Time Frame: 60 sec – 600 sec
    • 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.
  • Number of skin punctures
    • Time Frame: 60 sec – 600 sec
    • Number of skin punctures is defined as the counted number of skin punctures until aspiration of venous blood.
  • The procedure was aborted
    • Time Frame: 2 minutes – 20 minutes
    • Discontinuation of the procedure or change of site for vascular access
  • Localization of catheter tip in x-ray
    • Time Frame: 1 day- 7 days
    • 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.
  • The anaesthetists subjective experience with needle visualization
    • Time Frame: 3 min- 20 min
    • After performing the vascular access the anaesthetists are asked about how they found the visualization of the needle using a Numeric Rating Scale
  • The anaesthetists subjective experience with the needle placement
    • Time Frame: 3 minutes – 20 minutes
    • After performing the vascular access the anaesthetist is asked how the needle placement was using a Numeric Rating Scale
  • Incidence of Treatment-Emergent Adverse Events, pneumothorax hematothorax
    • Time Frame: 1 minutes- 1 day
    • 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
  • Incidence of delayed Treatment-Emergent Adverse Events pneumothorax, hematothorax
    • Time Frame: 5 minutes – 1 week
    • 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • Oslo University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Trine Kåsine, Principal investigator – Oslo University Hospital
  • Overall Official(s)
    • Trine Kåsine, MD, Principal Investigator, Department of Anaesthesiology Oslo University Hospital, Oslo, Norway

Clinical trials entries are delivered from the US National Institutes of Health and are not reviewed separately by this site. Please see the identifier information above for retrieving further details from the government database.

At TrialBulletin.com, we keep tabs on over 200,000 clinical trials in the US and abroad, using medical data supplied directly by the US National Institutes of Health. Please see the About and Contact page for details.