PROSPECTIVE RANDOMISED STUDY TO COMPARE REINSERTION OF ENDOTRACHEAL TUBE OVER AIRWAY EXCHANGE CATHETER (AEC) ALONE OR OVER AIRWAY EXCHANGE CATHETER WITH I-GEL AS A CONDUIT.
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Success rate (in %) of reinsertion of endotracheal tube, over airway exchange catheter, in both the groups
研究概览
简要总结
IMPLICATION STATEMENT & BACKGROUND: Extubation related airway problems are underestimated and under-reported. Airway exchange catheters (AEC) and supra-glottic airway device (SAD) supported extubation are now well established. This study explores whether the combination of AEC inside a SAD (i-gel in this case) be synergistic or not.
METHODS: One hundred ASA I/II patients were randomized to tracheal intubation using AEC alone (n=50) or over iGel with AEC (n=50) in situ. At the end of surgery, after adequate reversal and maintaining sedation using fentanyl and 2% Isoflurane, AEC was inserted and patient’s trachea extubated in one group. In the other group, iGel was slid over the AEC following extubation. Thereafter, ETT was re-inserted over AEC with or without iGel as conduit. First attempt and overall intubation success rates were evaluated and tracheal intubation times were measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adults having ASA Grade I or II physical status.
排除标准
- •1.) Predicted difficult airway as shown by one/more of the following i.
- •MMP class > II ii.
- •Inter incisor gap<3cms iii.
- •Thyromental distance<6cms iv.
- •Sternomental distance <12cms v.
- •Neck motion<90° vi.
- •Neck circumference>40cms 2.) Perioperative airway deterioration.
- •3.) Patients at an increased risk of aspiration, including pregnant patients.
- •4.) Nasogastric tube in situ at the time of extubation.
结局指标
主要结局
Success rate (in %) of reinsertion of endotracheal tube, over airway exchange catheter, in both the groups
时间窗: After the completion of surgery
次要结局
- Manoeuvres needed for success of re-intubation
- Time
- Haemodynamic response to re-intubation(change in heart rate, B.P.)