Comparison of airway management with I-gel,Cuffed Laryngeal Mask Airway and Cuffed Endotracheal Tube in patients undergoing surgery under general anaesthesia-A Randomized Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Compare I-gel,Cuffed Laryngeal Mask Airway and cuffed Endotracheal intubation with regards to the ease of insertion,insertion time and number of attempts
研究概览
简要总结
Endotracheal intubation is the definitive way of securing the airway during anaesthesia. However, owing to the profound cardiovascular responses and risks of local trauma, in cases of difficult airway scenario and in rare extreme events of unable to intubate, the Supraglottic Airway Devices play a superior role of which I-gel and Laryngeal Mask airway are the two commonly used ones. This will be a randomised clinical trial conducted to compare the airway management with I-gel, Cuffed Laryngeal Mask Airway and Cuffed Endotracheal tube in patients undergoing surgery under general anaesthesia.
A total of 150 patients, aged 18-60 years of either sex , undergoing elective surgical procedures under general anaesthesia, with American Society of Anaesthesiologists (ASA) physical status I and II, fulfilling the inclusion criteria and willing to give consent will be enrolled in the study. They will be randomly allocated into three groups, Group A, Group B and Group C whose airway will be secured by I-gel, Cuffed Laryngeal Mask Airway and Cuffed Endotracheal Tube respectively. The number of insertion attempts, ease of insertion and insertion time will be noted and compared in each case.Hemodynamic changes and side effects after device insertion like blood on device removal,hoarseness,dysphagia and sorethroat will be noted and compared.
The findings and observations made during the entire study will be tabulated,graphically depicted whenever possible,statistically analysed and inference will be drawn.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients aged between 18 to 60years 2.American Society of Anaesthesiologists status I and II 3.Patients undergoing elective surgical procedure under general anaesthesia of duration 60 to 90 minutes 4.Modified Mallampati Score I and II 5.Thyromental distance above 6.5 centimetre.
排除标准
- •1.Patients with recognised or threatened risk of gastroesophageal reflux 2.Obese patients with BMI more than 30 3.Pregnant women 4.Patients with co existing cardiac disease 5.Patients on antihypertensives 6.Patients undergoing procedures requiring head and neck manipulation 7.Chronic infection or diseases 8.Patients with history of motion sickness.
结局指标
主要结局
Compare I-gel,Cuffed Laryngeal Mask Airway and cuffed Endotracheal intubation with regards to the ease of insertion,insertion time and number of attempts
时间窗: Outcome will be assessed after insertion of airway device at baseline.
次要结局
- To compare the hemodynamic changes after insertion of the airway device & associated side effects if any.(Hemodynamic changes will be assessed after insertion of airway device at baseline,every 1 minute until 5 minutes,every 5 minutes until 30 minutes,every 10minutes until the end of surgery.Side effects like blood on removal of device,hoarseness,dysphagia & sore throat will be noted immediately after removing the airway device & 24 hours after surgery.)
研究者
JYOLSNA M S
Regional Institute of Medical Sciences, Imphal ,Manipur