COMPARISON OF EFFECTS OF LARYNGEAL MASK AIRWAY (LMA) SUPREME CUFF INFLATION WITH AIR, AIR: OXYGEN MIXTURE AND OXYGEN: NITROUS OXIDE MIXTURE IN ADULTS: A RANDOMIZED DOUBLE BLIND STUDY
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To compare the changes in cuff pressure intraoperatively with different gas composition (Air, Air: Oxygen mixture, Oxygen: Nitrous oxide mixture) used to inflate the LMA Supreme by cuff pressure monitor.(Manometer)
研究概览
简要总结
The laryngeal mask airway is one of the airway devices that has gained popularity during the past decade.LMA cuff inflation with the normal recommended injection volume results in the residual volume of the cuff being exceeded during anaesthesia resulting in severe and even fatal injury including tracheal pain or stridor. A variety of media are used for cuff inflation which varies with their efficacy to maintain a stabilised cuff pressure and to prevent post intubation-related emergence phenomenon. This will be a prospective randomized double blind study which will be done to compare the effects of laryngeal mask airway (LMA) supreme cuff inflation with air, air: oxygen mixture and oxygen: nitrous oxide mixture in adults. The study will be carried out on 120 adults of ASA grade I and II who will be divided into three groups of 40 each. Supreme LMA cuff inflation will use Air only in group A, Oxygen: Air mixture in Group OA andOxygen: Nitrous oxide mixture in Group ON. All the groups will be compared with respect to changes in cuff pressure intraoperatively with different gas composition used to inflate the LMA Supreme with a manometer and
post-operative pharyngolaryngeal morbidity. The observations will be recorded on the proforma and the results will be statistically analysed in the three groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Double Blind Double Dummy
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 Grade I and II Age 18 to 60.
排除标准
- •Inadequate mouth opening
- •Patient with BMI > 35 kg/m2
- •Anticipated difficult airway.
- •Patient having diseases with risk of aspiration like gastro oesophageal reflux disease, hiatus hernia.
- •Oropharyngeal pathology
- •ASA grading III, IV
- •Cervical spine pathology 8.
结局指标
主要结局
To compare the changes in cuff pressure intraoperatively with different gas composition (Air, Air: Oxygen mixture, Oxygen: Nitrous oxide mixture) used to inflate the LMA Supreme by cuff pressure monitor.(Manometer)
时间窗: The primary outcome will be compare the changes in cuff pressure intraoperatively with different gas composition (Air, Air: Oxygen mixture, Oxygen: Nitrous oxide mixture) used to inflate the LMA Supreme by cuff pressure monitor.(Manometer)
次要结局
- a. To compare the effect of LMA Supreme cuff pressure change on intraoperative(ventilator parameters)
