A Prospective Randomized Comparative Study of Silicone Wire-Reinforced Tube versus Polyvinyl chloride tube for Tracheal Intubation through LMA CTrachâ„¢ in Patients Undergoing General Anesthesia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Success rate of intubation including first attempt success rate
研究概览
简要总结
In this patient blinded randomized trial 60 patients aged 18-65 years belonging to ASA physical status 1 and 2 will be randomized to be tracheally intubated through LMA CTrach with either PVC tube (Group polyvinylchloride tube) or Silicon tube (Group Silicon tube). The success rate of intubation, first attempt success rates, number of manipulations required during the process of intubation, ease of intubation, time required for successful intubation, incidence and severity of sore throat and hoarseness of voice will be observed and compared between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 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
- •Patients of either gender aged between 18- 65 years, belonging to American Society of Anesthesiologists (ASA) physical status 1 and 2, who are scheduled for surgical procedures under general anesthesia requiring tracheal intubation.
排除标准
- •1.Mouth opening less than 2.5cms 2.Patients with anticipated difficult airway 3.Patients with risk of regurgitation and pulmonary aspiration (inadequate fasting, pregnancy, morbid obesity, emergency surgeries requiring rapid sequence induction of anesthesia, history suggestive of acid peptic disease) 4.BMI >35 kg/m2 5.Oral, maxillofacial or laryngeal pathology where LMA CTrachâ„¢ insertion is contraindicated or difficult.
结局指标
主要结局
1. Success rate of intubation including first attempt success rate
时间窗: during tracheal intubation with LMA CTrach (one point assessment)
2. Ease of intubation
时间窗: during tracheal intubation with LMA CTrach (one point assessment)
次要结局
- The number and type of manipulations of LMA CTrachâ„¢ done to bring the tracheal tube tip and glottis in alignment during intubation(At the time of tracheal intubation)
- time taken from the beginning of insertion of tracheal tube till removal of LMA CTrach following successful intubation(At the time of tracheal intubation)
- The presence or absence of sore throat and hoarseness of voice during first 24 hours following surgery and its severity(assessed at one point 24 hours following surgery and as reported by the patient at any point of time during these 24 hours)
- Presence of blood or blood stain on LMA CTrachâ„¢ and tracheal tube after its removal(at the time of removal of LMA and extubation)