Prospective Randomized Comparison of the Ambu Aura-i and Air-Q Intubating Laryngeal Airways as a Conduit for Tracheal Intubation in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Ease and time to successful tracheal intubation
研究概览
简要总结
The purpose of this study is to determine whether there is a clinically relevant difference in time to tracheal intubation when using fiberoptic bronchoscope as a guide to intubate through the Ambu Aura-i or air-Q ILA.
详细描述
The goal of this prospective randomized study is to compare the Ambu Aura-i and air-Q ILA in children with normal airway anatomy, in order to evaluate the effectiveness of fiberoptic tracheal intubation through these two devices. The ease of placement, fiberoptic grade of laryngeal view, time to tracheal intubation, time for device removal after intubation, and peri-operative complications will also be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 盲法
- Single (Care Provider)
入排标准
- 年龄范围
- 1 Month 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children undergoing general anesthesia requiring tracheal intubation
- •Weight 5-20 kg
- •Age one month-six years
排除标准
- •ASA class IV, V Emergency procedures
- •History of a difficult airway
- •Active upper respiratory tract infection
- •Children receiving emergent surgery
结局指标
主要结局
Ease and time to successful tracheal intubation
时间窗: participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
from the time of fiberoptic bronchoscope entry into the device until positive clinical signs indicating successful tracheal intubation (i.e., presence of bilateral breath sounds, appropriate end-tidal CO2) are confirmed
次要结局
- Ease and time to place airway(participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Number of attempts to place the supraglottic device and tracheal tube(participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Airway Leak Pressure(participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Fiberoptic grade of laryngeal view(participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Time to remove device(participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Airway maneuvers(participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Adverse effects(Participants will be followed for the duration of anesthesia and 24 hours postoperatively)
研究者
Narasimhan Jagannathan
primary investigator; MD
Ann & Robert H Lurie Children's Hospital of Chicago