A Randomized Comparison of the Ambu AuraGain™ and LMA Supreme™ in Infants and Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Oropharyngeal (airway) leak pressure - Initial
研究概览
简要总结
The purpose of this study is to determine whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain and the Laryngeal Mask Airway (LMA) Supreme.
详细描述
The goal of this prospective randomized study is to compare whether there is a clinically relevant difference in airway leak pressures between the Ambu AuraGain (sizes 1.5 and 2) and the Laryngeal Mask Airway (LMA) Supreme. Parameters of clinical relevance such as insertion success rates, fiberoptic view of the glottic opening, ease and speed of gastric tube placement, airway stability, 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
- 3 Months 至 6 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Scheduled for surgery utilizing a supraglottic airway device
- •ASA (American Society of Anesthesiologists) I-III classification
- •Weighing between 5 - 20 kilograms
排除标准
- •Active respiratory infection
- •History of difficult mask ventilation
- •Diagnosis of congenital syndrome with difficult airway management
- •Active gastrointestinal reflux
- •Coagulopathy
- •Significant Pulmonary disease
- •Emergent surgery
研究组 & 干预措施
Ambu AuraGain
Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines
干预措施: Ambu AuraGain (size 1.5 or size 2.0) (Device)
LMA Supreme
Subjects will receive the Ambu AuraGain size 1.5 or 2.0 based on manufacturer guidelines
干预措施: LMA Supreme (size 1.5 or size 2.0) (Device)
结局指标
主要结局
Oropharyngeal (airway) leak pressure - Initial
时间窗: Assessed intraoperatively at the time of confirmed device placement
The airway pressure at which an airway leak is observed after successful placement of the supraglottic airway
Oropharyngeal (airway) leak pressure - 10 Minutes
时间窗: Assessed intraoperatively, 10 minutes after the initial confirmed placement of the device
The airway pressure at which an airway leak is observed 10 minutes after successful placement of the supraglottic airway
次要结局
- Time for Successful Placement of the Supraglottic Airway(Assessed intraoperatively at the time of confirmed device placement)
- Number of attempts to placement of Supraglottic Airway(Assessed intraoperatively at the time of confirmed device placement)
- Fiberoptic Grade of Laryngeal View through Supraglottic Airway(Assessed intraoperatively at the time of confirmed device placement)
- Gastric Tube Insertion Ease of Placement(Assessed intraoperatively at the time of confirmed gastric tube placement)
- Gastric Tube Insertion Time(Assessed intraoperatively at the time of confirmed gastric tube placement)
- Gastric Tube Insertion Attempts(Assessed intraoperatively at the time of confirmed gastric tube placement)
- Postoperative Complications(Participants will be followed for the duration of hospital stay. Outcome measure will be assessed postoperatively in recovery unit.)
- Intraoperative Complications(Assessed intraoperatively)
研究者
Narasimhan Jagannathan
Primary Investigator; M.D.
Ann & Robert H Lurie Children's Hospital of Chicago