Ultrasound-guided Vena Jugularis Interna Catheterization Lateral Approach Short Axis in - Plane Technique
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- Success rate of first attempt
研究概览
简要总结
Central venous access is one of the most frequently used venous accesses in intensive care units. Insertion of the central venous catheter belongs to the basic skills of an intensivist. One of the veins that are available for catheterization is the internal jugular vein. It is recommended to perform jugular vein catheterization along with real-time ultrasound guidance.
Imaging of the jugular vein is usually performed in two ways: on the short axis or on the long axis. The puncture method is described based on the type of needle imaging technique, out-of-plane or in-plane method.
Traditionally, catheterization is performed by a medium approach during imaging the vein on a short axis using the out-of-plane technique. The main advantage of this procedure is proper imaging of the jugular vein and surrounding anatomical structures. However, the limited needle display is rather inconvenient, as only the needle tip can be displayed. This method of central venous catheterization has a first attempt success rate of 80%.
This study is going to concentrate on discussing the performing of jugular vein catheterization by a novel lateral approach in-plane technique during imaging of the vein on the short axis. This procedure for placement of a central venous catheter into the internal jugular vein has not yet been described nor investigated. The above-mentioned method combines the advantage of reliable jugular vein imaging together with proper imaging of the whole needle. At the same time, the fixation of the catheter in the supraclavicular region allows for a better nursing routine, hence increasing the patient's comfort.
详细描述
All potential candidates to enroll will undergo an examination by an anesthetist. If the candidate meets inclusion/ exclusion criteria, the candidate will sign an informed consent and be enrolled in the study. The calculated number of needed subjects is 180 (90 in each group). In the next step, all enrolled subjects will be randomized by computer block randomization into two groups.
- In group A catheterization of vena jugularis interna will be done by lateral approach with visualization of the vein on its short axis with ultrasound and the in-plane technique will be used.
- In group B catheterization of the vena jugularis interna will be done by conventional approach with visualization of the vein on its short axis with ultrasound and the out-of-plane technique will be used.
Later then all enrolled subjects will undergo examination by an anesthetist or neurologist focused on neurological deficits in the upper limbs. The assessment will be done by Neurological Impairment Scale (NIS).
In the next step catheterization of the vein will be done according to the latest international recommendations and the randomized group.
The time of the start of catheterization and the time of the end of catheterization will be recorded.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient older than 18 years with an indication of central venous catheter placement
排除标准
- •Not signing the informed consent
- •BMI under 16,5
- •Contraindication of central venous catheter placement into internal jugular vein (thrombosis, site infection, bleeding diseases, anticoagulation or antiaggregation therapy)
- •hypersensitivity to sterile ultrasound gel
- •neurological impairment on upper limbs
- •neurodegenerative disorder
研究组 & 干预措施
The Novel Lateral Approach
In this arm, the catheterization of the internal jugular vein is done with ultrasound guidance displaying the vein on its short axis using a lateral approach and in-plane technique. The catheterization is done according to the newest international recommendations for good clinical practice.
干预措施: Ultrasound Guided Lateral Approach Catheterization of Jugular Internal Vein (Procedure)
The Conventional Approach
In this group catheterization of the jugular internal vein is done by conventional approach with ultrasound guidance using displaying on its short axis and using the out-of-plane technique.
干预措施: Ultrasound Guided Conventional Approach Catheterization of Jugular Internal Vein (Procedure)
结局指标
主要结局
Success rate of first attempt
时间窗: Measured from the time the cannulation starts (local anesthetic infiltration) till insertion of the catheter, up to 120 minutes.
Primary outcome is to prove that first attempt success rate by the novel approach is comparable with the success rate of the first attempt success rate of the conventional approach.
次要结局
- Functional time of the catheter(Measured from inserting the catheter till the extraction of the catheter, up to 45 days.)
- Rate of complications(Measured from the start of cannulation (local anesthetic infiltration) till extraction of the catheter, up to 45 days.)
- Risk of neurological impairment assessed by Neurological Impairment Scale(Measured from insertion the catheter till the extraction of the catheter, up to 45 days.)
研究者
Michal Kalina
Principal Investigator
Masarykova Nemocnice v Usti nad Labem, Krajska Zdravotni a.s.