I-Gel Versus Disposable Laryngeal Mask Airway for General Anesthesia With Controlled Ventilation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 主要终点
- Sealing pressure and peak airway pressure.
研究概览
简要总结
Randomized controlled trial comparing performance of the I-gel and disposable Laryngeal Mask Airways under controlled ventilation. 200 patients, 100 in each arm. Measurement of peak airway and sealing pressures. Postoperative questionnaires at 1 and 24hrs.
Hypothesis
There is no difference between the performance* of the I-gel and disposable laryngeal mask airways for controlled ventilation under general anesthesia.
*as defined by peak airway pressure and sealing pressures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 89 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females.
- •Age 18-89 inclusive.
- •ASA grade 1-
- •Elective surgery
排除标准
- •Emergency surgery.
- •Surgery within the peritoneum.
- •Surgery requiring prone or steep head-down positioning.
- •Patients at increased risk of aspiration
研究组 & 干预措施
A
Laryngeal Mask Airway insertion
干预措施: Insertion of laryngeal mask airway (AuraOnce mask) (Device)
A
Laryngeal Mask Airway insertion
干预措施: Measurement of airway pressures (Other)
B
I-gel insertion
干预措施: Insertion of I-gel airway (Device)
B
I-gel insertion
干预措施: Measurement of airway pressures (Other)
结局指标
主要结局
Sealing pressure and peak airway pressure.
时间窗: Under anaesthesia.
次要结局
- Postoperative patient symptoms(1hr and 24hrs postoperatively)