A Randomized Trial Comparing the Laryngeal Mask Airway-SupremeTM With the i-gelTM in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 2
- 主要终点
- Airway Leak Pressure
研究概览
简要总结
The aim of this randomized prospective study is to compare two single-use laryngeal mask airways with a provision of a gastric drain tube allowing for evacuation of gastric contents, the i-gel and the LMA Supreme, in pediatric patients undergoing positive pressure ventilation. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme.
详细描述
The goal of this study is to compare the LMA Supreme and i-gel in children having surgery. The investigators hypothesize that airway leak pressures with the i-gel will not be significantly different clinically (higher) when compared with the LMA Supreme. Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached. The ease of placement, fiberoptic grade of laryngeal view, feasibility of use during positive pressure ventilation, ease of gastric tube placement, and complications (airway related, gastric insufflation, and trauma) 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Months 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Children undergoing general anesthesia using a supraglottic airway device
- •weight 5-50 kg
- •age 3 months-11 years
排除标准
- •ASA class IV, V Emergency procedures
- •active respiratory infection
- •known history of difficult mask ventilation
- •a diagnosis of a congenital syndrome associated with difficult airway management
- •airway abnormalities (e.g., laryngomalacia, subglottic stenosis)
- •active gastrointestinal reflux
- •coagulopathy
- •clinically significant pulmonary disease(s)
结局指标
主要结局
Airway Leak Pressure
时间窗: Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours
Airway leak pressures will be measured by recording the circuit pressure at which equilibrium is reached when fresh gas flow is delivered at 3L/min when the pressure limiting valve is closed.
次要结局
- Time to secure the 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 device(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)
- Gastric insufflation(Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Ease of gastric tube placement(Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Feasibility of positive pressure ventilation(Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Quality of the airway(Participants will be followed for the duration of anesthesia and after surgery, an expected average of 12 hours)
- Incidence of device repositioning and/or replacement(Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours)
- Oropharyngolaryngeal morbidity at discharge(Participants will be followed for the duration of anesthesia and after surgery, an average of 24 hours)
- Oropharyngolaryngeal morbidity at 24 hours post-operatively(Measured at 24 hours after device placement/study initiation)
研究者
Narasimhan Jagannathan
Principal investigator
Ann & Robert H Lurie Children's Hospital of Chicago