A Randomized Comparison of Pediatric I-gel, Air-Q With Classic Laryngeal Mask Airway in Terms of Clinical Performance and Fiber Optic Glottic View
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 180
- 试验地点
- 2
- 主要终点
- Airway leak pressure
研究概览
简要总结
The aim of this randomized trial will be to evaluate the clinical performance of the I-gel, air- Q ILA compared with the LMA classic in pediatric patients undergoing peripheral surgery under general anesthesia.
详细描述
The laryngeal mask airway (LMA) Classic has gained popularity for airway management in both anesthesia and resuscitation due to its ease of use. However, insertion of the LMA Classic is not always easy in children due to differences in airway anatomy compared with adults, and more complications are related to its use in younger children compared with adults.
The i-gel has been commercially available in sizes suitable for children since 2010. It has a non-inflatable cuff and an additional lumen for the active or passive drainage of gastric contents (except in size 1). It is available in four children's sizes (1, 1.5, 2 and 2.5).
The air-Q_ ILA, is easily inserted with the index finger of the right hand, while the anesthetist performed jaw's lift with left hand, without a rotational technique (Jagannathan N et al., 2011, Dar long et al, 2014 and Keil et al, 2015).
Oropharyngeal leak pressure is defined as the airway pressure at which air leaks into the mouth or enters the stomach (Hughes et al., 2012). This feature is the most common primary outcome parameter used to evaluate the safety and efficacy of supraglottic airway devices because high pressures generally indicate that adequate ventilation can be achieved without air leakage during positive pressure ventilation at high inspiratory pressures (Teoh et al., 2010).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 2 Years 至 9 Years(Child)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Weight: 15-30 kg. Age: 2-9 years. Sex: both males and females. ASA physical status: 1-
- •Operation: elective outpatient surgery in which airway management with a LMA would be appropriate.
排除标准
- •Active respiratory illness (cough, fever, rhinorrhea) on the day of anesthesia, Potentially difficult airway. Patients with history of neck, respiratory, or digestive tract pathology. Patients with gastroesophageal reflux, gastrointestinal stenosis or stricture
研究组 & 干预措施
Air-Q
Patients will be anesthetized using Air-Q_ ILA, with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer.
干预措施: Air-Q (Device)
LMA classic
Patients will be anesthetized using Classic laryngeal mask airway that will be inserted lubricated with partially deflated cuff. After insertion, the cuff will be inflated with the recommended volume of air.
干预措施: LMA Classic (Device)
I-gel
Patients will be anesthetized using I-gel LMA with its lubricated cuff inserted along the hard palate until resistance is felt, as recommended by the manufacturer.
干预措施: i- gel (Device)
结局指标
主要结局
Airway leak pressure
时间窗: intraoperative
Airway leak pressure will be determined by closing the adjustable expiratory pressure-limiting (APL) valve and setting the fresh gas flow rate to 3 L/min. The airway pressure at which an audible leak in the mouth is heard is recorded as the "leak pressure". If leak pressure reached 35 cmH2O, the expiratory valve will be opened. After adjusting the APL valve to 35 cmH2O, the maximum tidal volume (TVmax) will be measured by squeezing the balloon of anesthesia circuit until an audible leak occurred. Airway pressures were not allowed to exceed 35 cmH2O.
次要结局
- ventilation score(intraoperative)
- Heart rate(intraoperative)
- Fiberoptic laryngoscopic view(intraoperative)
- peripheral arterial oxygenation(intraoperative)
研究者
Hala Saad Abdel-Ghaffar
assistant professor
Assiut University
