Clinical trial NCT05045352: Echogenic Versus Non-echogenic Needles for Venous Access
Official title: Ultrasound Guided Subclavian Vein Cannulation. Echogenic Needles Versus Non-echogenic Needles
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Anesthesia
Vascular Access Complication
Keywords: vascular access,
ultrasound guided
echogenic needles
Lead sponsor: Oslo University Hospital
Sponsor class: OTHER
First posted: 2021-09-16
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two arms Venous access either with echogenic needles or with non-echogenic needles
Primary purpose: SUPPORTIVE_CARE

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Time from skin puncture of the needle until aspiration of venous blood.
timeFrame: 10 sec - 240 sec
Secondary outcomes:
measure: Time from skin puncture until catheter in place
timeFrame: 60 sec - 600 sec
measure: Success with venous access in first needling attempt
timeFrame: 60 sec - 600 sec
measure: Number of needling attempts before venous access
timeFrame: 60 sec - 600 sec
measure: Number of skin punctures
timeFrame: 60 sec - 600 sec
measure: The procedure was aborted
timeFrame: 2 minutes - 20 minutes
measure: Localization of catheter tip in x-ray
timeFrame: 1 day- 7 days
measure: The anaesthetists subjective experience with needle visualization
timeFrame: 3 min- 20 min
measure: The anaesthetists subjective experience with the needle placement
timeFrame: 3 minutes - 20 minutes
measure: Incidence of Treatment-Emergent Adverse Events, pneumothorax hematothorax
timeFrame: 1 minutes- 1 day
measure: Incidence of delayed Treatment-Emergent Adverse Events pneumothorax, hematothorax
timeFrame: 5 minutes - 1 week
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Oslo University Hospital
Study officials:
affiliation: Department of Anaesthesiology Oslo University Hospital, Oslo, Norway
name: Trine Kåsine, MD
role: PRINCIPAL_INVESTIGATOR
References: