Comparison of the clinical performance of I-gel and Ambu Aura Gain -supra-glottic airway devices in paediatric patients under controlled ventilation.

Ashka V Surve1 个研究点分布在 1 个国家目标入组 60 人开始时间: 2019年5月23日最近更新: 2019年9月5日

试验速览

阶段: 不适用
状态: 尚未招募
发起方
入组人数: 60
试验地点: 1
主要终点: The oropharyngeal seal pressure of I-gel is higher than Ambu Aura Gain in their individual studies. Whereas insertion of Ambu aura gain is faster than I-Gel.

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

As newer pediatric sized supra-glottic airway devices like I-gel and Ambu Aura Gain are available for use in clinical practice in children. It is important to evaluate their clinical performance and safety to establish superiority or equivalence to the existing devices. So, we choose this study to evaluate and compare overall performance of I-gel versus Ambu Aura Gain in pediatric patients undergoing general anesthesia. To compare the clinical performance of I gel with Ambu Aura Gain in pediatric population for providing adequate airway seal under controlled mechanical ventilation under general anesthesia.

研究设计

研究类型: Interventional
分配方式: Computer generated randomization
盲法: Participant Blinded

入排标准

年龄范围: 3.00 Year(s) 至 10.00 Year(s)（—）
性别: All

入选标准

•1.Patients age group 3-10 years 2.Either gender 3.Weight 10-35 kg 4.ASA physical status I/II 5.Patients admitted in SSGH and posted for 6.Elective surgeries requiring general anesthesia ( abdominal surgeries, upper limb surgeries, lower limb surgeries, head and neck surgeries etc.

排除标准

•1.Patient with risk factors of difficult airway (mouth opening of < 2cm, mallampatti class III and IV, limited neck extension, history of previous difficult tracheal intubation).
•2.Patients with recent upper respiratory tract infection.
•3.Patient with any known pulmonary and cardiovascular diseases.
•4.Patient with any conditions that increase the risk of gastro esophageal regurgitation.
•5.Parents or guardian not willing for participation.

结局指标

主要结局

The oropharyngeal seal pressure of I-gel is higher than Ambu Aura Gain in their individual studies. Whereas insertion of Ambu aura gain is faster than I-Gel.

时间窗: at 5 minute after insertion of the device, oropharyngeal leak pressure will be noted.

次要结局

Secondary outcomes are haemodynamic and respiratory parameters.(These secondary outcomes are observed throughout the duration of surgery.)

研究者

发起方

Ashka V Surve

申办方类型

Other [self money]

研究点 (1)

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