Ultrasound Guided Subclavian Vein Cannulation. Echogenic Needles Versus Non-echogenic Needles
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Time from skin puncture of the needle until aspiration of venous blood.
研究概览
简要总结
Randomized controlled intervention study comparing echogenic needles with non echogenic needles for ultrasound guided venous access in the subclavian vein.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Participant will be anesthetized and asleep Outcome assessor will not be in the operating theater during the procedure
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •undergoing a surgical procedure requiring a CVC Patients must be at least 18 years of age. Patients that have given informed written consent.
排除标准
- •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.
研究组 & 干预措施
Echogenic needle
venous access performed under ultrasound guidance with echogenic needles
干预措施: echogenic needles for intravenous access (Device)
Non-Echogenic needles
venous access performed under ultrasound guidance with non-echogenic needles
结局指标
主要结局
Time from skin puncture of the needle until aspiration of venous blood.
时间窗: 10 sec - 240 sec
Time from skin puncture of the needle until aspiration of venous blood in the syringe. Time till venous access
次要结局
- The anaesthetists subjective experience with needle visualization(3 min- 20 min)
- The anaesthetists subjective experience with the needle placement(3 minutes - 20 minutes)
- Number of skin punctures(60 sec - 600 sec)
- Localization of catheter tip in x-ray(1 day- 7 days)
- Success with venous access in first needling attempt(60 sec - 600 sec)
- Incidence of Treatment-Emergent Adverse Events, pneumothorax hematothorax(1 minutes- 1 day)
- Time from skin puncture until catheter in place(60 sec - 600 sec)
- Number of needling attempts before venous access(60 sec - 600 sec)
- The procedure was aborted(2 minutes - 20 minutes)
- Incidence of delayed Treatment-Emergent Adverse Events pneumothorax, hematothorax(5 minutes - 1 week)
研究者
Trine Kåsine
Principal investigator
Oslo University Hospital