A Cohort Evaluation of the Pediatric Igel Airway in 200 Children and in 50 Infants
概览
- 阶段
- 不适用
- 干预措施
- 未指定
- 疾病 / 适应症
- Anesthesia
- 发起方
- University Hospitals Bristol and Weston NHS Foundation Trust
- 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?
- 状态
- 终止
- 最后更新
- 14年前
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.
研究者
Michelle White
Consultant in Paediatric Anaesthesia and Critical Care
University Hospitals Bristol and Weston NHS Foundation Trust
入排标准
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)