Comparison of efficacy of two single use supraglottic devices with a reusable supraglottic device for ventilation in paediatric patients undergoing elective surgery under general anaesthesia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Oropharyngeal seal pressure of the device will be measured.
研究概览
简要总结
The efficacy of LMA ProSeal and Igel is compared with that of Blockbuster LMA for ventilation in children undergoing elective surgery under general anaesthesia by assessing oropharyngeal leak pressure. The primary outcome measured will be the oropharyngeal seal pressure measured at 5 minutes and 30 minutes after insertion of the device. Other secondary outcomes include the number of attempts taken for successful insertion of the device, time taken for effective ventilation, ease of insertion of device and gastric catheter and anatomical alignment of the device to glottic opening by Brimacombe score. The study will be done in children weighing 10 to 30 kilograms fulfilling the criteria of ASA 1 and 2 under elective surgery under general anaesthesia. The Sample size of the study is 156, that is 52 for each device.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 10.00 Year(s)（—）
- 性别
- All
入选标准
- •This study will be conducted in children weighing
- •30 kg, fulfilling the criteria of American Society of Anaesthesiologists (ASA) Physical Status 1 and 2, undergoing elective surgery under general anaesthesia with controlled ventilation.
排除标准
- •Patients with an anticipated difficult airway.
- •Patient with high risk of aspiration.
结局指标
主要结局
Oropharyngeal seal pressure of the device will be measured.
时间窗: Oropharyngeal seal pressure of the device will be measured at 5 minutes and 30 minutes after insertion of device.
次要结局
- Number of attempts taken for successful insertion of the device.(This will be noted after the successful insertion of the device.)
- Time taken for achieving effective ventilation.(It will be noted from, holding the supraglottic device at the teeth for insertion, to obtaining the first square wave capnograph tracing, confirming effective ventilation.)
- Anatomical alignment of the device to glottic opening by Brimacombe score.(It will be measured after the insertion of the device.)
- The ease of insertion of the device and the gastric catheter will be noted.(It will be noted after insertion of the device and the gastric catheter.)
研究者
Dr Faiez Farhan K M
VMMC and Safdarjung Hospital