Clinical Evaluation of Ambu® Auragain™ as a Conduit for Intubation in Paediatrics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 2
- 主要终点
- Time taken to successful intubation via the Ambu® AuraGain™
研究概览
简要总结
This study will be conducted as a prospective observational study
This study will be done in any of the operating theatres of University Malaya Medical Centre
This study will involve paediatric cases ( ages 3-12 years )posted for elective operations which require general anaesthesia with endotracheal intubation
Ambu Aura Gain will be used as a conduit for intubation
详细描述
All eligible participants will be approached and recruited Informed consent will be obtained Induction of general anesthesia will be as per usual standardized method Ambu® Auragain™ will be inserted A paediatric flexible endoscope will be used to view the glottis and railroad an endotracheal tube into the trachea Placement is confirmed and number of attempts and time required for successful intubation is recorded Ambu® Auragain™ will be removed Number of attempts and time taken for removal of Ambu® Auragain™ will be recorded Any complications will be noted and recorded
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Paediatric patients aged 3 - 12 years old
- •American Society of Anaesthesiologist (ASA) 1-2 patients
- •Patients must require standard endotracheal intubation for the procedure posted
排除标准
- •Documented history of difficult airway in previous general anaesthesia
- •Clinical features of difficult airway on physical examination
- •Syndromic patients, facial deformities, dental deformities, patients with facial trauma
- •Patients with recent (less than 2 weeks) or ongoing upper respiratory tract infection
- •Patients with existing pulmonary diseases or any risk of bronchospasm
- •Patients with known gastric outlet obstruction, reflux disease, or any risk of aspiration
- •Any other contraindication for device placement
- •Operations requiring specialised endotracheal tubes
- •Emergency operations or unanticipated difficult airway cases
- •Refusal of parental informed consent
结局指标
主要结局
Time taken to successful intubation via the Ambu® AuraGain™
时间窗: Time taken during procedure ( measured in seconds )
Successful intubation is confirmed via the equal air entry heard bilaterally on auscultation and a positive capnograph tracing
次要结局
- Time taken required for removal of Ambu® AuraGain™ post intubation(Time taken during procedure ( measured in seconds ))
研究者
Dr Lim Su Sian
Medical officer UD 48
University of Malaya