CTRI/2023/09/057684尚未招募不适用
A prospective randomized comparative study to assess the safety and efficacy of Ambu Aura Gain versus I-Gel in adult patients under General Anaesthesia
Department of Anaesthesia MMCRI Mysore1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2023年9月24日最近更新:
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
- Oropharyngeal leak pressure
研究概览
简要总结
This study is a prospective randomised comparative study to assess the safety and efficacy of Ambu Aura gain versus I-gel in adult patients under general anaesthesia in eleective surgeries in KR hospital, Mysore, India.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •All ASA grade I and II patients between 18-50 years of both sex.
- •Elective surgeries under general anaesthesia with controlled ventilation.
- •Body mass index 25-28 Kg/m
- •Duration of surgery <2hrs.
排除标准
- •Age <18 years and > 50 years.
- •All ASA grade III and above.
- •Mallampatti grade 3 and above.
- •Emergency surgeries.
- •Head and neck surgeries.
- •Patients with decreaesed mouth opening.
- •Patients with increased risk of aspiration.
- •Patients with BMI >28 Kg/m
- •Patients with abnormal or distorted anatomy of pharynx.
结局指标
主要结局
Oropharyngeal leak pressure
时间窗: 10 min | 2 min
Time taken for insertion.
时间窗: 10 min | 2 min
Ease of Insertion & number of attempts.
时间窗: 10 min | 2 min
Ease of insertion of Ryles tube .
时间窗: 10 min | 2 min
Fibreoptic bronchoscopic grading.
时间窗: 10 min | 2 min
次要结局
- Haemodynamic response, SpO2, EtCO2(Incidence of post operative complications)
研究者
研究点 (1)
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