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临床试验/NCT02925715
NCT02925715已完成4 期

Comparative Evaluation of Ultrasound Guided Supraclavicular and Infraclavicular Subclavian Venous Catheterizations in Adult Patients Undergoing Major Surgeries

Post Graduate Institute of Medical Education and Research, Chandigarh0 个研究点目标入组 96 人开始时间: 2015年9月1日最近更新:
适应症

试验速览

阶段
4 期
状态
已完成
发起方
入组人数
96
主要终点
puncture time of subclavian vein using ultrasound-guided supraclavicular or infraclavicular approach infraclavicular approaches in adults

研究概览

简要总结

Comparison of two techniques of central venous cannulation of subclavian vein using ultrasound was performed. ultrasound guided central venous cannulation is the standard practice today but its use in subclavian vein is technically challenging and not much literature is available. In this study 96 Patients were randomized into one of the groups and compared for various outcomes. The primary outcome studied was the time taken for procedure. Secondary objectives included comparison of total access time using both the techniques,comparison of first attempt success rate, comparison of the quality of needle visualization and the comparison of immediate (mechanical) and delayed complication rates.

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)

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

  • Healthy adults requiring central venous cannulation.

排除标准

  • History of prior catheterization.
  • Limited sites for access attempts (other catheters, pacemaker, prior surgery).
  • Previous difficulties during catheterization such as more than three punctures at one site, two sites attempted or failure to gain access.
  • Previous mechanical complications during catheterization.
  • Patients with infection at puncture site and contralateral pneumothorax.
  • Patients with trauma to clavicle and upper ribs, distorted anatomy of neck or clavicles.
  • Cervical spine injury.
  • Known vascular abnormality.
  • Untreated coagulopathy such as International Normalization Ratio(INR) ≥ 2, activated partial thromboplastin time >1.5 of normal or platelets <50,000/mm3
  • After 3 attempts at needle puncture.

结局指标

主要结局

puncture time of subclavian vein using ultrasound-guided supraclavicular or infraclavicular approach infraclavicular approaches in adults

时间窗: 1 year

will be measured in seconds

次要结局

  • total time taken for cannulation of veins using both the techniques.(1 year)
  • first attempt success rate(1 year)
  • quality of needle visualisation(1 year)
  • immediate and delayed complications with the two approaches(1 year)

研究者

发起方
Post Graduate Institute of Medical Education and Research, Chandigarh
申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr Vikas Saini

Associate Professor

Post Graduate Institute of Medical Education and Research, Chandigarh

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