A randomised controlled trial comparing tracheal intubation with or without fibreoptic guidance through Ambu AuraGain
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Time taken for successful tracheal intubation with or without fibreoptic guidance through Ambu AuraGain
研究概览
简要总结
RATIONALE :There is no previous study where Ambu aura gain is used for tracheal intubation with or without fibreoptic guidance and demonstrated the necessary time for successful tracheal intubation through Ambu aura gain .Hence this study is design to compare tracheal intubation with or without fibreoptic guidanceAIM:to evaluate ambu aura gain as a conduit for tracheal intubation with or without fibreoptic guidancePRIMARY IBJECTIVE: to evaluate the time taken for successful tracheal intubation with or without fibreoptic guidance.METHODOLOGY:in the operation theatre,standard monitors will be attached and routine conduct of general anaesthesia planned. Ambu aura gain will be inserted and depending on randomisation,tracheal intubation by endotracheal tube will be done either using fibreoptic or without fibreoptic guidance. OUTCOME MEASURES WILL INCLUDE:1)INTUBATION TIME: timed elapsed from disconnecting the ventiltor circuit on ambu aura gain till appearance of first normal capnogram with breathing circuit connected to ETT after placement in trachea.2.Number of attempts for insertion of ETT tube:
An attempt will be defined as removal of ETT from AAG after insertion in the trachea.
Total number of attempts for ETT intubation will be 3 for each group and after that it will be marked as a failure.
3. First attempt success rate:
The first attempt success rate of tracheal intubation with or without fibre optic guidance
through Ambu aura gain will be measured.
4.Ease of ETT intubation:
Grading of ease of intubation is according to the intubation anaesthesiologist
Grading of ease of ETT intubation:
| Grade 1 |
Very easy
|Grade 2
Easy
|Grade 3
Difficult
|Grade 4
Very difficult
**STATISTICAL ANALYSIS:**Unpaired t test / Mann Whitney U test will be used to compare normally distribute or non-normally distributed variables respectively. P <0.05 will be taken as significant. Statistical analysis will be done by SPSS version 20.0
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA I ,II Modified Mallampati Class I,II Patient admitted surgery under general anaesthesia.
排除标准
- •BMI more than 30kg per meter square, Pregnant women, Known or predicted difficult airway, Known case of COPD, asthma or any other restrictive or obstructive respiratory pathology, High risk for pulmonary aspiration.
结局指标
主要结局
Time taken for successful tracheal intubation with or without fibreoptic guidance through Ambu AuraGain
时间窗: Once, from disconnection of the circuit from Ambu AUra Gain till reconnecting it with the endotracheal tube
次要结局
- 1.Number of attempts for successful intubation
- 2.First attempt success rate(will be calculated after successful intubation is over)
- 3.Ease of endotracheal tube intubation(graded 1 to 4 after intubation is successful.)
研究者
Dr Vibhor Gupta
University College of Medical Sciences and GTB hospital