Safety and Efficacy Evaluation of The Nasopharyngeal Airway Embedded With Jet Ventilation Catheter(WEI NASAL JET) Applied for The Sedation of Outpatient Upper Gastrointestinal Endoscopy
试验速览
- 阶段
- 不适用
- 入组人数
- 1,800
- 试验地点
- 3
- 主要终点
- Low pulse oximetry incidence
研究概览
简要总结
Low pulse oximetry is the most common adverse events during sedation for upper gastrointestinal endoscopy. The main reason is the glossoptosis after sedation. In present study a new designed nasopharyngeal airway embedded with jet ventilation catheter(WEI NASAL JET) will be utilized in order to reduce the hypoxia. At the same time the safety will be evaluated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- •patients undergoing upper gastrointestinal endoscopy
- •age over 18 years old
- •Signed informed consent form
排除标准
- •a blood coagulation dysfunction or have a tendency of nose bleeding
- •a clear diagnosis of heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.)
- •a clear diagnosis of lung disease (asthma, chronic obstructive pulmonary disease, pulmonary embolism, pulmonary edema, lung cancer)
- •liver disease
- •kidney disease
- •increase in intracranial pressure
- •emergency operation
- •multiple trauma
- •American Society of Anesthesiologists (ASA) Physical Status classification above IV
- •with mouth, nose and throat infection
研究组 & 干预措施
Control group
Oxygen(2L/min) supplied with nasal catheter
Nasopharyngeal airway group
Oxygen(2L/min) supplied directly through WEI NASAL JET without jet ventilator
干预措施: Nasopharyngeal airway without jet ventilator (Device)
WEI NASAL JET group
Oxygen supplied through WEI NASAL JET with a manual jet ventilator
干预措施: WEI NASAL JET (Device)
结局指标
主要结局
Low pulse oximetry incidence
时间窗: Patients will be followed for the duration of hospital stay, an expected average of 2 hours
次要结局
- Other adverse events(Patients will be followed for the duration of hospital stay, an expected average of 2 hours)