Comparative Study of Baska & I-Gel for Spontaneously Ventilated Females During Minor Gynecological Procedures
试验速览
- 阶段
- 不适用
- 入组人数
- 60
- 主要终点
- seal pressure
研究概览
简要总结
The study aimed to compare safety of the 3rd generation Supra-glottic airway device (SAD) "Baska" to the I-Gel , regarding seal pressure, fitting on the larynx (detected by Fiberoptic) & complications. The study will be done for females undergoing minor gynecological procedures under general anesthesia with spontaneous ventilation.
详细描述
Population of study & disease condition : 2 equal groups (n=30), female patients enrolled for minor gynecological procedures (D&C or hysteroscopy), All patients received general anesthesia with spontaneous ventilation using Supra-glottic airway Device (SAD). Group A (Baska) & group B ( I-gel).
Inclusion Criteria: Age: 18-55, American Society of Anesthesia (ASA) 1 or 2, BMI<35 & Low risk of aspiration.
Exclusion Criteria: Anticipated upper airway problem, Gastrointestinal tract (GIT, disease, pregnancy & High risk of aspiration.
Methodology: All patients received fentanyl 1 micro gram/Kg, Propofol(2-4mg/Kg) was titrated to induce anesthesia, followed by manual ventilation with sevoflurane (2-4%) in Oxygen.All devices were inserted by one of 2 investigators.
Data collection: 1- Demographic Data: age,weight,height.2-duration of anesthesia.3- Data related to device insertion: Time of insertion,duration of anesthesia, seal pressure,peak airway pressure, Fiberoptic (FO)view of the larynx ,vomiting or regurgitation, postoperative laryngeal spasm or blood on the device after removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female ASA1,2
- •Age 18-55
排除标准
- •Anticipated upper airway problem
- •GIT disease
- •Pregnancy
- •High risk of aspiration
结局指标
主要结局
seal pressure
时间窗: seal pressure will be assessed 3minutes after induction of general anesthesia.
Airway Sealing Pressure in cmH2O at 5 mins postplacement.The airway sealing pressure was the pressure at which leak starts. This leak pressure was calculated as the plateau airway pressure reached with fresh gas flow 6 l/min, and pressure adjustment valve set at 70 cmH2O..
次要结局
- incidence of vomiting and regurgitation(from the start of operation till 10 minutes postoperative)
- Fiberoptic view of the larynx.(Fiberoptic view will be assessed 5 minutes after induction of anesthesia.)
- Peak airway pressure in CmH2O(during the operation the operation)
研究者
Nesrine El-Refai
professor
Cairo University