Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Echogenic needle | Active Comparator | venous access performed under ultrasound guidance with echogenic needles |
|
| Non-Echogenic needles | No Intervention | venous access performed under ultrasound guidance with non-echogenic needles |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| echogenic needles for intravenous access | Device | echogenic needles for intravenous access (subclavian vein) ultrasound guided procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Success with venous access in first needling attempt |
Not provided
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:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Trine Kåsine, MD | Department of Anaesthesiology Oslo University Hospital, Oslo, Norway | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oslo University Hospital | Oslo | 0424 | Norway |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Two arms Venous access either with echogenic needles or with non-echogenic needles
Not provided
Not provided
Participant will be anesthetized and asleep Outcome assessor will not be in the operating theater during the procedure
Success in first attempt is defined as one skin puncture and directly into the subclavian vein
| 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. | 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. | 60 sec - 600 sec |
| The procedure was aborted | Discontinuation of the procedure or change of site for vascular access | 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. | 1 day- 7 days |
| 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 |
| 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 |
| 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 |
| 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 |