A Cohort Evaluation of the Pediatric Igel Airway in 200 Children and in 50 Infants
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Does the i-gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children?
研究概览
简要总结
Once a child has been anaesthetised and is fully asleep, a special airway tube called a laryngeal mask is often inserted into their mouth to help with their breathing. This tube is removed just before the child wakes up.
A new type of airway tube, called an i-gel airway, has been developed for children, which is hoped will be easier to insert, safer once in position, and will be less likely to cause a sore throat after the anaesthetic than a standard laryngeal mask. The adult i-gel airway has been available for adults since 2007, and early trials have shown very encouraging results.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •All children weighing 5 -30kg
- •Classified by the American Society of Anesthesiology (ASA) as grade 1-2,
- •Scheduled for elective surgery under general anaesthesia, in whom a LMA or PLMA would otherwise be used for airway maintenance and in whom neuromuscular blocking drugs will not be used.
排除标准
- •Inability of patient or parents to understand the study or consent process
- •Neck pathology
- •Previous or anticipated airway problems
- •Pathology of airway, respiratory tract, upper gastrointestinal tract
- •Increased risk of regurgitation or aspiration
- •Weight >30kg or <5 kg
- •ASA 3 and above,
- •Emergency surgery
结局指标
主要结局
Does the i-gel (a new supraglottic airway device) perform adequately in anaesthetised healthy children?
时间窗: during anaesthesia
次要结局
- Ease of insertion, Complication rates and manipulation rates during use, Airway seal pressure, Effective ventilation, Post-operative sequelae(during anaesthesia and up to 24 hours postoperatively)
研究者
Michelle White
Consultant in Paediatric Anaesthesia and Critical Care
University Hospitals Bristol and Weston NHS Foundation Trust