Comparison of Ultrasound guided Brachiocephalic and internal jugular vein cannulation in neonates and infants:A prospective randomized controlled trial
试验速览
- 阶段
- 2/3 期
- 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 ultrasound guided in plane right IJV cannulation with & in plane supraclavicular left brachiocephalic vein cannulation with respect to the first attempt success rate .
研究概览
简要总结
COMPARISON OF ULTRASOUND GUIDED BRACHIOCEPHALIC AND INTERNAL JUGULAR VEIN CANNULATION IN NEONATES AND INFANTS:A PROSPECTIVE RANDOMIZED CONTROLLED TRIAL
recently an supraclavicular brachiocephalic vein cannulationhas emerged as newer approach with several advantages specially in difficult situations.However,to date there are only few studies comparing ultrasound guided in plane brachiocephalic vein cannulation to other approaches in pediatric patients and therefore a well designed randomized trials are warranted as most of the available data comes from non randomized studies,case series and case reports.The purpose of thid study is to compare USG guided in plane IJV vs supraclavicular in plane brachiocephalic vein cannulation.
MATERIAL AND METHODS:A total of 80 neonates and infants satisfying the inclusion criteria will be randomly alloted into one of the two groups(group A or Group B).After anesthesia induction,in group A for IJV cannulation,standord longitudinal in plane approach will be used and in group B Ultrasound guided left brachiocephalic vein cannulation will be done.The study parameters will be recorded by independent observor and will include the 1 st attempt success rate,cannulation time,number of cannulation attempts ,overall success and complications if any.On completion of procedure,furthur maintenance and subsequent anesthesia recovery would be as per anesthesiologist incharge.
STATISTICAL ANALYSIS:The data will be collected,compiled and analysed using EPI info.The qualitative variables will be expressed in terms of percentages.The quantitative variables will be categorised ad expressed in terms of percentages or mean and standord deviations.For normal data,difference between two groups will be analysed using paired or unpaired student t test.For non normal data,Mann whitney U test will be used.The difference between two proportion will be analysed usingchie -square or fisher exact test.All analysis will be two tailed ,and the significance level will be set at 0.05.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 0.00 Day(s) 至 12.00 Month(s)（—）
- 性别
- All
入选标准
- •A total of 80 patients of both sexes ,neonates(including low birth weight) and infants upto 1 year of age requiring central venous cannulation under general anesthesia with controlled ventilation as a part of their routine medical care were included in the study.
排除标准
- •Infection at the site of insertion 2.uncorrected severe coagulopathy (platelet count<50,000),on anticoagulant or antiplatelet medications.
- •Patients with hemodynamic instability intolerant to general anaesthesia.
- •known venous thrombosis of vessel.
结局指标
主要结局
To compare ultrasound guided in plane right IJV cannulation with & in plane supraclavicular left brachiocephalic vein cannulation with respect to the first attempt success rate .
时间窗: the first attempt success rate ,overall success rate ,cannulation time noted at baseline
次要结局
- To compare Ultrasound guided in plane right IJV & in plane supraclavicular left brachiocephalic vein cannulation with respect to overall success rate, cannulation time & complications(Any complication occuring with in 48 hours of cannulation)