Evaluation of the Quality of Ventilation With Facial Versus Nasal Mask After Induction of Anesthesia in Children 3 to 12 Years Old
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Average Oxygen saturation (SpO2)
研究概览
简要总结
In this single-blind clinical trial study, 70children who are candidates for lower abdominal elective surgery under general anesthesia presented at Imam Hossein Hospital in Isfahan will be included in the study and will be divided into 2 groups. In the first group, ventilation with facial mask and in the second group, ventilation with nasal mask will be done for three minutes. Then the reduction in SPO2 and the impossibility of ventilation of patients will be evaluated and compared between the two groups.
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
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age category between 3 to 12 years
- •Candidate for lower abdominal elective surgery under general anesthesia
- •No obstruction in the nasal pathway
- •No deformity and fractures in facial
- •No acute or chronic lung disease
排除标准
- •Impossibility of airway oropharyngeal ventilation
- •Impossibility of ventilation of the anatomical facial mask with neck extension
- •Dissatisfaction with participating in the study.
结局指标
主要结局
Average Oxygen saturation (SpO2)
时间窗: change from baseline at five minutes after incubation
Ventilation device
Average airway pressure
时间窗: change from baseline at five minutes after incubation
Ventilation device
Average End-tidal CO2 (EtCO2)
时间窗: change from baseline at five minutes after incubation
Ventilation device
次要结局
未报告次要终点
研究者
Amir Shafa
Director
Isfahan University of Medical Sciences