Evaluation of the Intubating Laryngeal Airway in Children - Phase 3
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Time of intubation
研究概览
简要总结
The Air-Q® intubating laryngeal airway (Air-Q® ILA) is an extraglottic device specifically engineered for use both as a standalone laryngeal mask airway (LMA) and as a rescue device or "Plan B" device in the event of a difficult airway. As with some other types of LMA, it is then possible to insert an endotracheal tube (ETT) through the Air-Q® ILA, either blindly or mounted on a fibreoptic bronchoscope (FOB), to achieve endotracheal intubation. This will be a prospective observational study of the Air-Q® ILA's performance.
详细描述
Hypothesis: The Air-Q® intubating laryngeal airway (Air-Q® ILA) will act as an excellent conduit for fibreoptic intubation.
Background: The laryngeal mask airway (LMA) is used during pediatric anesthesia for routine and difficult airway management. The ideal pediatric LMA device would provide excellent sealing at low pressure; facilitate easy endotracheal intubation; and be available in pediatric sizes. Such a device would be an invaluable addition to difficult pediatric airway management plans and, by increasing the likelihood of quickly and effectively securing the difficult airway, and decreasing the risk of catastrophic hypoxemia, would increase perioperative safety for children. The Air-Q® ILA is a modified LMA device whose features encompass the characteristics of the ideal LMA. Our objective is to determine whether or not this new airway device is an improvement over the current standard of care.
Specific Objectives:
To evaluate the performance characteristics of the Air-Q® ILA as a conduit for fibreoptic intubation
Methods:
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA I-III
- •Ideal body weight as determined from weight/height centile curves (>3rd & <97th centiles). Wei
- •Elective surgery
- •Appropriate subject and procedure for airway management by endotracheal intubation.
排除标准
- •ASA status IV-V
- •Emergency surgery
- •Anticipated difficult intubation
- •Contraindication to LMA placement
- •Aspiration risk; gastro-esophageal reflux disease
- •Clinically significant pulmonary disease
- •Coagulopathy
- •Distorted airway anatomy judged likely to compromise LMA placement
- •Allergy to any LMA components
结局指标
主要结局
Time of intubation
时间窗: from start of fibreoptic intubation to end
次要结局
- heart rate(during intubation)
- arterial oxygen saturation(during intubation)
- rise in end-tidal CO2(during intubation)
研究者
Simon Whyte
Principle Investigator
University of British Columbia