Echogenic Versus Non-echogenic Needles for Venous Access
Study Details
Study Description
Brief Summary
Randomized controlled intervention study comparing echogenic needles with non echogenic needles for ultrasound guided venous access in the subclavian vein.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: Echogenic needle venous access performed under ultrasound guidance with echogenic needles |
Device: echogenic needles for intravenous access
echogenic needles for intravenous access (subclavian vein) ultrasound guided procedure
|
| No Intervention: Non-Echogenic needles venous access performed under ultrasound guidance with non-echogenic needles |
Outcome Measures
Primary Outcome Measures
- 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 Outcome Measures
- 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.
- 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
- 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.
- 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
- Adverse events during the procedure [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
- Adverse effects after the procedure [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
Eligibility Criteria
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:
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Patients that do not speak or understand Norwegian language.
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Skin disease or infection affecting the whole-body surface or within the area of examination.
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Patients with untreated coagulopathy
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Known vascular abnormality
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Any reason why, in the opinion of the investigators, the patient should not participate.
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Subject participates in a potentially confounding drug or device trial during the course of the study.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Oslo University Hospital
Investigators
- Principal Investigator: Trine Kåsine, MD, Department of Anaesthesiology Oslo University Hospital, Oslo, Norway
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- REK 85090