Safety and Benefits of Using Laryngeal Mask Airway to Keep Airway Potency During Fiber-optic Bronchoscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- pulse oximetry <90%,
研究概览
简要总结
Bronchoscopy is a method of diagnosis and treatment of common respiratory diseases and lung recognized for many years.
Since the action takes place in the airways and in light of the use of sedation, when performing, the procedure requires caution to keep potent airway and breathing sufficient enough.
Most of the bronchoscopy done without the aid of equipment for advanced airway protection. During the operation done monitoring hemodynamics: such as blood pressure, pulse and respiratory such as percutaneous oxygen saturation and carbon dioxide.
Laryngeal Mask Airway (LMA) - is a tool that has been shown to be effective in securing of airway respiratory activity during positive-pressure ventilation.
Several studies have shown that the use of LMA is a convenient and safe while performing bronchoscopy for airways and lungs. However, most of the studies were for certain patient groups such as children, immuno-compromised patients.
Or benefits and safety LMA in front of intubation during bronchoscopy.
Our aim to assess the safety and efficacy LMA in not mechanically ventilated patients undergoing flexible elective bronchoscopy .
Another objective, to examine whether there is a special group of patients enjoy the LMA more than others.
Patients will be divided randomly into two groups alternately by order, one patient study group and the next one to control.
Study group : LMA is inserted under sedation and used during the procedure.
Control group - performing bronchoscopy under sedation without LMA.
About 50 people are needed each group.
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
- None
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
- •Above 18 y.o
- •Competency to sign informed consent.
- •Room air oxygen saturation above 95%
- •Stable hemodynamically and respiratory during the start procedure.
- •Undergoing elective bronchoscopy.
排除标准
- •Pregnant women and special groups will not be included in the study.
结局指标
主要结局
pulse oximetry <90%,
时间窗: during bronchoscopy procedure
Percutaneous Carbon Dioxide >55%,
时间窗: during bronchoscopy procedure
arrhythmia by ecg monitoring.
时间窗: during bronchoscopy procedure
次要结局
未报告次要终点
