"Comparison of safety and efficacy in ultrasound guided supraclavicular and infraclavicular subclavian vein cannulation in ICU patients:A randomized clinical study"
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare the complications during USG guided supraclavicular and infraclavicular subclavian vein cannulation
研究概览
简要总结
Central vein catheter (CVC) insertion is an essential and routine procedure of modern medicine in critically ill patients in intensive care unit (ICU). CVC catheterization is required for both invasive monitoring as well as therapeutic purposes. USG guided subclavian vein cannulation is associated with lesser numbers of complications as compared to blind landmark technique.The aim of study is to determine the difficulties and advantages of subclavian venous
catheterization using supraclavicular versus and infraclavicular approach under real time ultrasound guidance in ICU patients. Primary objective of this study is to compare the complications during USG guided supraclavicular and infraclavicular subclavian vein cannulation. This prospective, randomized, comparative study will be conducted after approval from the institutional ethical committee. All the patients will be assessed and check-up will done including detail history, general and systemic examination and clinical laboratory tests will be conducted. Patients or their relatives will be explained about the concerned technique and written and informed consent will be obtained.
This hospital based study will be conducted on 80 critically ill patients requiring CVC insertion. Patients who will be admitted to surgical ICU for intensive management whether mechanically ventilated or on spontaneous ventilation of age >18 years will be randomly assigned to two groups of 40 each using computer generated number table. The allocations will be concealed in sequentially numbered, sealed, opaque envelopes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Not Applicable
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)(—)
- 性别
- All
入选标准
- •Patients of age more than 18 years of both gender requiring central line placement for therapeutic or monitoring purpose.
排除标准
- •1.Patient/attendant refusal 2.Patient having an infection at puncture site 3.Patient having pneumothorax/SVC syndrome 4.Patient having coagulation abnormality 5.Patient having distorted anatomy of neck or fracture clavicle, 6.Patient having platelets count less than 50000/dl.
结局指标
主要结局
To compare the complications during USG guided supraclavicular and infraclavicular subclavian vein cannulation
时间窗: up to 7 days
次要结局
- To compare the success rate of subclavian vein cannulation, procedure time, CVC related blood stream infection in both approaches.(up to 7 days.)
