The Influence of Head and Neck Position on Performance of Ambu AuraGain™
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Oropharyngeal leak pressure
研究概览
简要总结
The influence of different head and neck positions on the effectiveness of ventilation with the Ambu AuraGain airway remains unevaluated.
This study aimed to evaluate the influence of different head and neck positions on ventilation with the AuraGain airway.
AuraGain will be placed in all patients, and mechanical ventilation will be performed using a volume-controlled mode with a tidal volume of 10 ml/kg.
The expiratory tidal volume, peak inspiratory pressure, oropharyngeal leak pressure, and ventilation score will be assessed first for the neutral head position and then for the extended, flexed, and rotated head positions in a random order.
Fiberoptic bronchoscopic view will be also assessed for each head and neck positions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Other
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults who were to undergo elective surgery under general anaesthesia using supraglottic airway device
排除标准
- •Patients who had risk factor for difficult intubation
- •BMI > 30kg/m2
- •Emergency operation without NPO
- •History of cervical spine surgery or disease
- •History of esophageal operation or gastroesophageal reflux disease
研究组 & 干预措施
Neutral
After insertion of Ambu AuraGain™, the variables will be assessed at each positions including neutral, flexion, extension, right rotation under random order.
Flexion
After positioning the subjects' neck to flexion, the variables will be assessed.
干预措施: Flexion (Procedure)
Extension
After positioning the subjects' neck to extension, the variables will be assessed.
干预措施: Extension (Procedure)
Right rotation
After positioning the subjects' head to right rotation, the variables will be assessed.
干预措施: Right rotation (Procedure)
结局指标
主要结局
Oropharyngeal leak pressure
时间窗: 30 seconds after positioning of head and neck
The airway pressure at which a leak sound is detected around the patient's mouth and at which the airway pressure has reached equilibrium, when the pressure-limiting valve of the anesthesia breathing system is closed and the fresh gas flow rate was fixed at 3 L/min.
次要结局
- Peak inspiratory pressure(30 seconds after positioning of head and neck)
- Ventilation score(30 seconds after positioning of head and neck)
- Expiratory tidal volume(30 seconds after positioning of head and neck)
- Fiberoptic score(30 seconds after positioning of head and neck)
研究者
Jin-Tae Kim
Professor
Seoul National University Hospital