Echogenic Versus Non-echogenic Needles for Venous Access

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

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

Study Overview

• Status: Completed
• Conditions: Anesthesia; Vascular Access Complication
• Intervention / Treatment: Device: echogenic needles for intravenous access

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.

• Study Type: Interventional
• Enrollment (Actual): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Norway
  • Oslo, Norway, 0424
    • Oslo University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

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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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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
Incidence of Treatment-Emergent Adverse Events, pneumothorax hematothorax	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
Incidence of delayed Treatment-Emergent Adverse Events pneumothorax, hematothorax	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

Collaborators and Investigators

• Sponsor: Oslo University Hospital
• Investigators: Principal Investigator: Trine Kåsine, MD, Department of Anaesthesiology Oslo University Hospital, Oslo, Norway

Study record dates

Study Major Dates

• Study Start (Actual): January 12, 2022
• Primary Completion (Actual): August 30, 2022
• Study Completion (Actual): August 30, 2022

Study Registration Dates

• First Submitted: September 3, 2021
• First Submitted That Met QC Criteria: September 14, 2021
• First Posted (Actual): September 16, 2021

Study Record Updates

• Last Update Posted (Actual): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: ultrasound guided; vascular access,; echogenic needles
• Other Study ID Numbers: REK 85090

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No