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临床试验/NCT03395691
NCT03395691已完成不适用

Comparison of the Proximal Approach and Distal Approach of Axillary Vein Catheterization Under Ultrasound Guidance in Cardiac Surgical Patients With Risk of Bleeding: a Prospective Randomized Controlled Trial

Shanghai Zhongshan Hospital1 个研究点 分布在 1 个国家目标入组 198 人开始时间: 2018年2月11日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
198
试验地点
1
主要终点
First puncture success rate

研究概览

简要总结

Ultrasound-guided axillary vein catheterization can be performed via the proximal or distal approach of the axillary vein. The aim of our study is to compare the first puncture success rate and safety between the two approaches of ultrasound-guided axillary vein catheterization in cardiac surgical patients with risk of bleeding.

详细描述

For patients after cardiac surgery, antiplatelet drugs or anticoagulants are usually used for preventing thrombosis. Use of those drugs is associated with increased risk of bleeding. Any invasive procedures may put those patients at additional risk of bleeding. Ultrasound (US) has become widely accepted to guide safe and accurate central venous catheterization.The axillary vein in the infraclavicular area is an alternative choice for subclavian vein. Ultrasound images of the infraclavicular axillary vein differ according to its position. Proximal infraclavicular axillary vein is a direct continuation of the subclavian vein. The associated anatomy is simple and the vein is straight and thick in longitudinal axis view, which are in favor of successful puncture. Meanwhile, distal axillary vein also has anatomical advantages for safe and successful cannulations. Distal axillary vein lies further away from the artery and chest wall, and the overlap between distal axillary vein and artery gets greater on moving laterally. It is still unknow that one of the puncture approaches is superior to the other. Until now, there are no studies comparing two puncture approaches in high bleeding risk patients. The aim of the study is to compare the success rate of first puncture and safety of US-guided proximal and distal axillary venous catheterization in cardiac surgery patients with risk of bleeding.

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
Single (Participant)

盲法说明

Patients were randomized to the Proximal Approach (PA) or Distal Approach (DA) group in a 1:1 ratio using a computerized system. The allocation process was intensively managed by an allocation group using sequentially numbered containers and the allocation result was concealed until it was implemented. When a patient was eligible, the investigator informed allocation group to get intervention group allocated to the patient: PA or DA group. Because of feasibility issues, operators were not blinded to the assignment.

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Cardiac surgical patients in Cardiac Surgery Intensive Care Unit
  • Axillary vein catheterization is needed according to the clinical practice
  • receiving oral antiplatelet or anticoagulants at least three days

排除标准

  • fracture of the ipsilateral clavicle or anterior proximal ribs
  • subclavian and/or axillary vein thrombosis
  • local infection of the puncture area
  • subclavian and/or axillary veins which are not clearly visualized using ultrasound
  • already presence of subclavian or axillary vein catheter
  • requiring an emergency axillary vein catheterization

研究组 & 干预措施

The distal approach

Active Comparator

The first two attempts via the distal approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the proximal approach.

干预措施: The distal approach (Procedure)

The proximal approach

Active Comparator

The first two attempts via the proximal approach will be performed . If the first two attempts failed, the subsequent attempts of venipuncture were performed using the distal approach.

干预措施: The proximal approach (Procedure)

结局指标

主要结局

First puncture success rate

时间窗: approximately 3 minutes

Central venous catheter established upon first punction attempt

次要结局

  • access time(within 1 hours)
  • overall success rate(within 1 hours)
  • the number of attempts(within 1 hours)
  • The approach success rate(within 1 hours)
  • Complication rate(Day 1)
  • time to successful cannulation(within 1 hours)

研究者

发起方
Shanghai Zhongshan Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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