A Randomized Comparison of Free-handed Fiberoptic Intubation Compared With Fiberoptic Intubation Through an Air-QTM Intubating Laryngeal Airway in Children Less Than Two Years of Age: Does Operator Experience Affect Time to Successful Tracheal Intubation?
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Time for successful fiberoptic tracheal intubation
研究概览
简要总结
The goal of this prospective randomized study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. The question the investigators are trying to answer is: Does the operator experience make a significant difference in the time for successful fiberoptic guided tracheal intubation with and without the use of an air-Q intubating laryngeal airway?
详细描述
The aim of this study is to compare the effect of operator experience on the ability to use fiberoptic-guided intubation in children less than two years old, with and without the use of an air-Q as a conduit. The ease and time for placement of the air-Q, fiberoptic grade of laryngeal view, time for fiberoptic tracheal 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
- None
入排标准
- 年龄范围
- 1 Day 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy (ASA I to III) children who will be intubated as part of their general anesthesia plan for their scheduled surgeries
- •Age 1 month - 2 years
- •Weight 1-20 Kg
排除标准
- •Children with active respiratory infection
- •Known history of difficult mask ventilation
- •Diagnosis of a congenital syndrome associated with difficult airway management
- •Airway abnormalities (e.g., laryngomalacia, subglottic stenosis).
研究组 & 干预措施
Fiberoptic Intubation performed by an expert
Tracheal intubation will be performed by an expert anesthesia attending with and without use of the air-Q
干预措施: air-Q, followed by fiberoptic intubation (Device)
Fiberoptic Intubation performed by an expert
Tracheal intubation will be performed by an expert anesthesia attending with and without use of the air-Q
干预措施: Free-hand Fiberoptic Intubation (Device)
Fiberoptic Intubation performed by a novice
Tracheal intubation will be performed by an anesthesia trainee with and without use of the air-Q
干预措施: air-Q, followed by fiberoptic intubation (Device)
Fiberoptic Intubation performed by a novice
Tracheal intubation will be performed by an anesthesia trainee with and without use of the air-Q
干预措施: Free-hand Fiberoptic Intubation (Device)
结局指标
主要结局
Time for successful fiberoptic tracheal intubation
时间窗: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
The time for successful intubation will be from removal of the face mask or disconnection of the circuit from the air-Q until evidence of end-tidal CO2 is confirmed.
次要结局
- Time to successful placement of the Air-Q(Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Number of attempts to place the Air-Q(Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Ease for placement of the air-Q(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)
- Peri-operative complications(Measured at 24 hours after device placement/study initiation)
- Number of attempts for fiberoptic tracheal intubation(Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Ease for fiberoptic tracheal intubation(Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
研究者
Narasimhan Jagannathan
Primary Investigator
Ann & Robert H Lurie Children's Hospital of Chicago