Anesthesia, Vascular Access Complication
Conditions
Keywords
vascular access,, ultrasound guided, echogenic needles
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.
Interventions
DEVICEechogenic needles for intravenous access
echogenic needles for intravenous access (subclavian vein) ultrasound guided procedure
Sponsors
Oslo University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participant will be anesthetized and asleep Outcome assessor will not be in the operating theater during the procedure
Intervention model description
Two arms Venous access either with echogenic needles or with non-echogenic needles
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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. |
| 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. |
| The procedure was aborted | 2 minutes - 20 minutes | Discontinuation of the procedure or change of site for vascular access |
| 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. |
| 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 |
| 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 |
| 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 |
| 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. |
Countries
Norway
Outcome results
None listed