A Randomized Comparison of the I-gel and Air-Q as Conduits for Fiberoptic-guided Tracheal Intubation in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Time to Successful Tracheal Intubation
研究概览
简要总结
The purpose of this study is to determine if there is a difference in time for successful fiberoptic guided tracheal intubation through the i-gel or air-Q supraglottic airway.
详细描述
The goal of this randomized study is to evaluate the efficacy of the i-gel as a conduit for fiberoptic tracheal intubation when compared to the air-Q in children. Intubations will be performed by residents in training. The primary outcome is of time for successful tracheal intubation. The investigators hypothesize that residents will intubate the trachea faster when using the air-Q as compared to the i-gel. The ease of placement of the supraglottic airway device, fiberoptic grade of laryngeal view, 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
- •Age one month to six years
排除标准
- •ASA class IV, V
- •Children receiving emergent surgery
- •History or high suspicion of a difficult airway
- •Active upper respiratory tract infection
研究组 & 干预措施
air-Q
Patients will receive the air-Q with size based on manufacturer recommendations of body weight
干预措施: air-Q (Device)
i-gel
Patients will receive the i-gel with size based on manufacturer recommendations of body weight
干预措施: i-gel (Device)
结局指标
主要结局
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
Time to successful tracheal intubation when using fiberoptic bronchoscopy to intubate through the i-gel or air-Q ILA. Three separate times will be measured by an independent observer: 1) Time to first glottic view: defined as the duration of time ending with the first view of the glottic opening. 2) Time to carinal view: defined as the duration of time ending with visualization of the carina. 3) Time to successful tracheal intubation: defined as the duration of time ending with the observation of a square wave end-tidal capnogram after successful tracheal intubation
次要结局
- Ease of Placement of Supraglottic Airway(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 Placement of Supraglottic 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(participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Supraglottic Airway Leak Pressure(participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Postoperative Complications(Participants will be followed for the duration of anesthesia and 24 hours postoperatively)
- Number of Attempts to Place the Tracheal Tube(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)
研究者
Narasimhan Jagannathan
Primary Investigator; MD
Ann & Robert H Lurie Children's Hospital of Chicago