Echogenic Versus Non-echogenic Needles for Venous Access

Not Applicable

Completed

• Conditions: Vascular Access Complication; Anesthesia
• Interventions: Device: echogenic needles for intravenous access

• Registration Number: NCT05045352
• Lead Sponsor: Oslo University Hospital

Brief Summary

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

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 Timeline

• Study First Submitted: 2021-09-03
• Study First Submitted QC: 2021-09-14
• Study First Posted: 2021-09-16
• Study Start: 2022-01-12
• Primary Completion: 2022-08-30
• Study Completion: 2022-08-30
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-26
• Last Update Posted: 2024-02-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Echogenic needle	echogenic needles for intravenous access	venous access performed under ultrasound guidance with echogenic needles

Primary Outcome Measures

Name	Time	Method
Time from skin puncture of the needle until aspiration of venous blood.	10 sec - 240 sec	Time from skin puncture of the needle until aspiration of venous blood in the syringe. Time till venous access

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Oslo University Hospital; 🇳🇴 Oslo, Norway