Comparative Evaluation of Ambu Airway and Intubating Laryngeal Mask Airway for tracheal intubation in patients undergoing general anaesthesia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Total intubation time beginning from the time of insertion of supraglottic airway upto successful endotracheal tube intubation verified by detection of carbon dioxide on the capnogram
研究概览
简要总结
60 elective surgical candidates aged 18-80 years belonging to ASA I-III grading physical status undergoing general anaesthesia will be divided into 2 groups of 30 each by a computer generated randomised allocation table. Group F will be intubated using FASTRACH intubating laryngeal mask airway and Group A will be intubated using AMBU Aura-i intubating laryngeal mask airway.The total intubation time will be recorded and compared between both groups along with ease of intubation and first attempt success rate of intubation between the two groups and incidence of postoperative sore throat will be recorded. Based on this a comparative evaluation between FASTRACH and Ambu Aura-i laryngeal mask airways will be done.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •60 adult surgical candidates aged 18 to 80 years with American Society of Anaesthesiologists physical status grading I-III with a Mallampati score of I or II presenting for elective surgery requiring general anaesthesia.
排除标准
- •Elective surgical candidates with previously known difficult airway, requiring prone positioning, interincisor distance <2.5cm, thyromental distance<5cm, or with clinically suspected difficult airway or with contraindications to laryngeal mask airway insertion or with indications for rapid sequence induction.
结局指标
主要结局
Total intubation time beginning from the time of insertion of supraglottic airway upto successful endotracheal tube intubation verified by detection of carbon dioxide on the capnogram
时间窗: Total intubation time beginning from the time of insertion of supraglottic airway upto successful endotracheal tube intubation verified by detection of carbon dioxide on the capnogram. T1 - time of insertion of LMA. T2 - time of insertion of endotracheal tube. T3 - time of removal of LMA
次要结局
- Time for LMA insertion, Time for endotracheal tube insertion, number of participants in whom supraglottic airway insertion was successful on first attempt, number of participants in whom endotracheal tube insertion was successfull on first attempt, number of participants with overall successful for supraglottc airway device placement, Ease of Supraglottic airway insertion, number of participants with overall intubation success, postoperative discomfort in post-anaesthesia care unit(Total intubation time beginning from the time of insertion of supraglottic airway upto successful endotracheal tube intubation verified by detection of carbon dioxide on the capnogram)