A Randomized Prospective Controlled Trial Comparing the Laryngeal Tube Suction Disposable and the Supreme Laryngeal Mask Airway: The Influence of Head and Neck Position on Oropharyngeal Seal Pressure
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 160
- 主要终点
- Primary outcome oropharyngeal seal pressures, in cm H2O
研究概览
简要总结
The investigators study compared the Laryngeal Tube Suction-Disposable with the Supreme Laryngeal Mask Airway, hypothesizing that the two devices would provide adequate oropharyngeal seal pressure in different head and neck positions and perform similarly during pressure controlled ventilation in neutral position, despite differences in their structural design.
详细描述
Laryngeal Tube Suction Disposable, LTS-D (VBM Medizintechnik GmbH , Sulz, Germany) and Supreme Laryngeal Mask Airway, SLMA (Intavent Orthofix, Maidenhead, UK) are second generation, single-use, supraglottic airway devices( SADs), with added gastric access, for use in spontaneously and mechanically ventilated patients undergoing general anesthesia.
The effectiveness of the LTS-D and the SLMA has been well established; however, the oropharyngeal seal pressure of both devices in different head/neck positions and the performance of these devices using positive pressure ventilation have not been evaluated. Changing the head/neck position can alter the sealing capabilities of the SAD.
To the investigators best knowledge there are no studies comparing the oropharyngeal seal pressure in different head and neck position when using these devices.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Investigator)
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
- •Patients ASA I and II with normal airways, for minor elective surgical
排除标准
- •Age <18 yr, weight <50 kg, or > 100 kg , a known difficult airway, active gastro esophageal reflux disease
结局指标
主要结局
Primary outcome oropharyngeal seal pressures, in cm H2O
时间窗: 5 min
Oropharyngeal leak pressure was determined by closing the expiratory valve of the anesthesia breathing system and a fixed gas flow of the 3 liters minute. The airway pressure at which an equilibrium was reached was noted( maximun allowed 40 cm H2O)
次要结局
- Fiberoptic position(5 min)
研究者
LUIS.GAITINI
M.D.
Bnai Zion Medical Center