Comparison of i-gel with ProSeal laryngeal mask airway for airway management in paediatric patients
试验速览
- 阶段
- 4 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Oropharyngeal seal pressure
研究概览
简要总结
The study is a prospective randomised and controlled study comparing the efficacy of I -gel and ProSeal laryngeal mask airway for airway management in 100 children between 2 to 6 years of age that will be conducted in Government medical college and Hospital, Chandigarh The primary outcome is oropharyngeal seal pressure in these two devices. The secondary outcomes are correct positioning insertion time quality of the initial airway fibroptic view respiratory parameters including Peak airway pressure mean airway pressure minute ventilation resistance compliance mean airway pressure at two five minutes post insertion of the device and hemodynamic parameters at the start after induction 2 mins and 5 mins after insertion of the device lastly after removal of the device The data will be analysed by SPSS software kolmogorov smirnov test will be used for normality of distribution Parametric data will be assessed by unpaired t test and non parametric data by mann whitney test Data will be presented as mean SD
results demographic data similar in both groups The OLP in i gel group was significantly higher than in PLMA group Time taken for successful insertion in PLMA was longer than in i gel group The quality of initial airway was found to be higher in i gel group
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 2.00 Year(s) 至 6.00 Year(s)(—)
- 性别
- All
入选标准
- •1.American Society of Anesthesiologist (ASA) physical status I/II of either sex 2.Age group of 2-6 years 3.Weight between 10-30 kg 4.Scheduled for short duration elective surgeries requiring general anaesthesia with controlled ventilation.
排除标准
- •1.Upper respiratory tract infection 2.Anticipated difficult airway 3.Children at increased risk of aspiration.
- •Gastro esophageal reflux disease, non fasting status 4.Cardiorespiratory or cerebrovascular disease.
结局指标
主要结局
Oropharyngeal seal pressure
时间窗: just after insertion of the airway
次要结局
- Number of Attempts(Insertion time (seconds))
