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临床试验/CTRI/2023/10/058552
CTRI/2023/10/058552尚未招募不适用

"Comparison of safety and efficacy in ultrasound guided supraclavicular and infraclavicular subclavian vein cannulation in ICU patients:A randomized clinical study"

Uttar Pradesh university of medical science Saifai Etawah1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2023年10月20日最近更新:

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.)

研究者

发起方
Uttar Pradesh university of medical science Saifai Etawah
申办方类型
Government medical college

研究点 (1)

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