Echogenic Versus Non-echogenic Needles for Venous Access

Anesthesia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05045352
• Other study ID #: REK 85090
• Status: Completed
• Phase: N/A
• Start date: January 12, 2022
• Est. completion date: August 30, 2022

Study information

• Verified date: February 2024
• Source: Oslo University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anesthesia
• Vascular Access Complication

Intervention

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

Locations

Country	Name	City	State
Norway	Oslo University Hospital	Oslo

Sponsors (1)

Lead Sponsor	Collaborator
Oslo University Hospital

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	The procedure was aborted	Discontinuation of the procedure or change of site for vascular access	2 minutes - 20 minutes
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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