Comparison of Air QTM Intubating Airway Versus Ambu-Aura Intubating Laryngeal Mask Obese Patients Under General Anaesthesia.
试验速览
- 阶段
- 不适用
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- airway seal pressure
研究概览
简要总结
Supraglottic airway devices are important tools for airway management. Supraglottic airway devices have been introduced into brief surgical interventions because they are less invasive than intubation and safer than mask to maintain the patency of airway after induction of anesthesia. They are inserted via the oral route and can be used in emergency conditions when tracheal intubation and mask anesthesia are challenging.
Air Q intubating airway and Ambu Aura intubating laryngeal mask are two Supraglottic airway devices that are widely used.
Aim of the work is to compare Air-Q intubating laryngeal airway versus Ambu-Aura intubating laryngeal mask regarding sealing pressure and Fiberoptic intubation in class II obese patients.
详细描述
Randomized comparative trial that will be performed in Kasr Al Ainy hospital, Cairo University, Cairo, Egypt.ASA II patients from 20 to 50 years of age, undergoing minor surgry were included in this study. 40 patients will be allocated into 2 equal groups using computerized software and enclosed in sealed opaque envelopes:
GQ ( n=20 ): Where Air-Q intubating laryngeal airway will be used for ventilation & intubation through fiberoptic bronchoscope.
GA ( n=20 ): Where Ambu-Aura intubating laryngeal mask will be used for ventilation & intubation through fiberoptic bronchscope.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients aged 18-65 years old.
- •Sex: both genders.
- •With American society of anaesthesiologists (ASA) physical activity II.
- •Scheduled for elective surgery under general anaesthesia requiring endotracheal tube.
- •Class II obese patients (BMI 34.9 - 39.9 kg/m2).
- •Surgery: short time procedures ≥ 60 minutes, ≤ 120 minutes e.g.: breast surgery, elbow or foot surgery.
排除标准
- •• Patient refusal.
- •Patients with any respiratory tract abnormalities as laryngeal masses & facial deformities as fracture mandible.
- •Patients with risk of pulmonary aspiration as in full stomach patients.
- •Patients at risk of regurgitation of gastric content as in gastroesophageal reflux disease (GERD) and pregnant females.
- •Emergency operation.
- •Patients with obstructive sleep apnea.
- •Patients prepared for laparotomy or laparoscopic procedures.
- •Patients with risk of bleeding.
结局指标
主要结局
airway seal pressure
时间窗: 1 minute
Measuring the seal pressure above which the oropharyngeal leak through the supraglottic device will occur (1 minute after confirmation of successful insertion).
次要结局
- Success rate of intubation by fiberoptic bronchoscope(1 minute)
- Success rate(1 minute)
- heart rate(2 hours)
- Laryngeal view grade.(1 minute)
- arterial blood pressure(2 hours)
研究者
Bassant M. Abdelhamid
associate professor
Cairo University