NCT01543360已完成不适用
Comparison of Axillary Versus Subclavian Vein Strategies for Central Venous Catheterization Under Continuous Ultrasound Guidance: a Prospective, Randomized, Non-inferiority Study
Centre Hospitalier Universitaire de Nīmes2 个研究点 分布在 1 个国家目标入组 132 人开始时间: 2012年6月1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
- 132
- 试验地点
- 2
- 主要终点
- Central venous catheter established within first 2 puncture attempts
研究概览
简要总结
The main objective of this study is to compare the rate of successful establishment of a central venous catheter in the first two attempts of ultrasound-guided puncture between two techniques: (1) a subclavian technique versus (2) an axillary technique.
详细描述
The secondary objectives of this study are to compare the following between the two techniques:
- the success rate of the establishment of a central venous catheter
- the success rate of establishment of a central venous catheter at the first attempt at venipuncture
- for non-failures (eg, a catheter is placed in the first four trys), time to cannulation
- the presence / absence of the following complications:
- arterial puncture (yes / no)
- pneumothorax (yes / no)
- hemothorax (yes / no)
- hematoma (yes / no)
- nerve injury (yes / no)
- aberrant course (yes / no)
The reasons catheter placement failures will also be described.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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 must have given his/her informed and signed consent
- •The patient must be insured or beneficiary of a health insurance plan
- •The patient is available for 24 hours of follow-up
- •Patient requiring the establishment of a central venous catheter
排除标准
- •The patient is in an exclusion period determined by a previous study
- •The patient is under judicial protection, under tutorship or curatorship
- •The patient refuses to sign the consent
- •It is impossible to correctly inform the patient
- •The patient is pregnant, parturient, or breastfeeding
- •Patient has a body mass index < 15 or > 40
- •Congenital or acquired anatomical deformity (radiation therapy, trauma, surgery) of the axillary and/or subclavian regions
- •Bleeding disorder (platelets < 50,000, prothrombine < 50%, activated cephaline time > 2 times the control value)
- •Severe hypoxemia defined by a ratio PaO2 / FIO2 < 100
- •Infection of the puncture area
- •Known thrombosis of the subclavian or axillary veins
- •Scheduled length of hospitalization less than 24 hours
- •Agitated or non-cooperative patient
- •The patient has already been included in this study
- •subclavian and axillary veins are not simultaneously echogenic on one or both sides (left and right).
结局指标
主要结局
Central venous catheter established within first 2 puncture attempts
时间窗: approximately 3 minutes
yes/no
次要结局
- Central venous catheter established upon first punction attempt(approximately 3 minutes)
- Establishment of a central venous catheter(approximately 3 minutes)
- presence/absence of complications(Day 1)
- The time necessary for the establishment of a central venous catheter(approximately 3 minutes)
研究者
研究点 (2)
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