I-Gel vs Ambu Laryngeal Mask Airways in Infants and Children Undergoing Surgical Procedures: A Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 112
- 主要终点
- Airway Leak Pressure
研究概览
简要总结
This study will guide the anesthetists regarding the appropriate selection of the LMA in neonatal age group based on scientific basis.
This study will add up to existing literature about the safety of LMA usage in neonates and infants. Furthermore it may shed some light on which LMA type will be more feasible and effective for neonatal/ infants usage.
详细描述
Laryngeal mask airways (LMAs) are in practice of anesthesia since early 1980s. Pediatric and neonatal patients (including ex-premature) have also been benefited by the use of LMA. There are many advantages of LMA over endotracheal tube (ETT) in pediatric patients like ease of insertion, securing airway rapidly, avoidance of muscle relaxants, reduced incidence of sore throat, post operative hoarseness and coughing at the time of extubation, greater hemodynamic and intraocular pressure (IOP) stability. LMA has been recognized internationally in control of airway in difficult and failed intubation.
There are different types of pediatric LMAs available e.g. I-gel, ProSeal, LMA supreme, LMA classic, LMA unique, LarySeal and Ambu. These devices differ morphologically from each other (silicone, polyvinyl chloride or soft gel). There have been several randomized controlled studies comparing different LMAs in adults, however, the literature is sparse in which such comparison has been made in patients with weight 10 kg or below.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Elective surgical procedures
- •No muscle relaxant agents
- •No other comorbidities
排除标准
- •Emergency surgical procedures
- •Full stomach
- •Subjects with upper respiratory tract infection
- •Failed caudal block
结局指标
主要结局
Airway Leak Pressure
时间窗: 17 months
It will be measured in mmHg unit and the expiratory valve will be closed with a fresh gas flow of 3 l.min-1 until an audible leak is heard, airway pressure will not be allowed to exceed 25 cmH2O), and then released completely
次要结局
- Success at first attempt(18 months)
- Oxygen Desaturation less than 90%(18 months)
- Gastric Insufflation(18 months)
- Manipulation of the Device(18 months)
- Effective airway time(18 months)
- Ease of insertion(18 months)
研究者
Dr Abdulrahman Alzahem
Associate Professor and Consultant
King Saud University