Randomized controlled intervention study comparing echogenic needles with non echogenic needles for ultrasound guided venous access in the subclavian vein.
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
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Enrollment
100
echogenic needles for intravenous access (subclavian vein) ultrasound guided procedure
Oslo University Hospital
Oslo, Norway
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
Time frame: 10 sec - 240 sec
Time from skin puncture until catheter in place
Time from skin puncture until the catheter in place in the subclavian vein.
Time frame: 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
Time frame: 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.
Time frame: 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.
Time frame: 60 sec - 600 sec
The procedure was aborted
Discontinuation of the procedure or change of site for vascular access
Time frame: 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.
Time frame: 1 day- 7 days
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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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 5 minutes - 1 week