NCT03162757已完成不适用
Comparison of Ultrasound-guided Central Venous Catherterization Via the Lower Internal Jugular Vein or the Subclavian Vein
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 210 人开始时间: 2017年1月26日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 210
- 试验地点
- 2
- 主要终点
- Successful placement catheter from a maximum of two attempts
研究概览
简要总结
The aim of this pilot study is to establish the success rate of catheterization of the lower jugular vein and the subclavian vein under ultrasound guidance in real time. The purpose is to compare the two techniques and to determine the best design for a full study (superiority, non-inferiority). This is a 2-arm randomized control study. The randomization ensures the comparability of the groups and allows evaluation of the feasibility and potential bias for further comparative studies.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The patient has been, or will be, informed as soon as their state of health allows them to be entered into the study of its objectives, constraints and the patient's rights
- •The patient have given their free and informed consent and signed the consent form
- •The patient must be insured or a beneficiary of a health insurance plan
- •The patient is over 18 years old
- •The patient needs a venous catheter in the superior vena cava
排除标准
- •The patient is already participating in another interventional study that could influence the results of this study
- •The patient has participated in another interventional study within the previous 3 months that could influence the results of this study
- •The patient is in a period of exclusion determined by a previous study
- •The patient is under judicial protection or is an adult under guardianship
- •The patient refuses to sign the consent form
- •Non-echogenic patient
- •Moribund patient
- •The patient has a contra-indication to one or other of the approaches: infection of the insertion zone, known thrombosis, severely dyspneic
- •Patient has severe coagulation problems: PT<40%, platelets<50 000 and curable anticoagulation with antiXa > 0.5 or INR>
- •Patient has a congenital or acquired deformation at the entry site
结局指标
主要结局
Successful placement catheter from a maximum of two attempts
时间窗: During procedure
Binary yes/no
次要结局
- success at first attempt(within 1 hour)
- Pneumothorax(1 day)
- failure(within 1 hour)
- arterial puncture(within 1 hour)
- mediastinal hematoma(1 day)
- thrombosis(until removal of catheter; on average 6.5 days)
- time between puncture until insertion of guide(within 1 hour)
- number of dressings(over length of hospitalization; maximum 40 days)
- arrhythmia(within 1 hour)
- abberant placement of catheter(1 day)
- haemothorax(1 day)
- clinical variables associated with failure of the techniques(within 24 hours)
- catheter infection(at removal of catheter; on average 6.5 days)
- catheter colonization(at removal of catheter; on average 6.5 days)
- nurse-rated satisfaction at each dressing replacement(over length of hospitalization; maximum 40 days)
研究者
研究点 (2)
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