Comparison of new generation Baska mask with I-gel in elective surgery under general anaesthesia: A prospective randomized controlled trial.
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- To compare oropharyngeal seal pressure (OLP) while using I-Gel and Baska mask at various time intervals
研究概览
简要总结
This study is a prospective randomized controlled trial comparing the I-Gel and Baska mask regarding the quality of ventilation and ease of insertion in 80 patients undergoing routine surgeries admitted at AIIMS Gorakhpur. The primary outcome measures will be to compare Oropharyngeal seal pressure(OLP) while using I-Gel and Baska mask at various time intervals. Secondary outcomes are to compare the ease of insertion, leak fraction, intra-operative hemodynamic changes and any post-operative complications, hoarseness, sore throat or dysphagia while using either device at various time intervals. Safety outcome will be recording and reporting of adverse events.
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
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient belonging to American Society of Anaesthesiologists physical status (ASA) I and II, who are scheduled for routine surgeries under general anaesthesia.
排除标准
- •Patient’s refusal,
- •Mouth opening of less than 3 fingers or with difficult airway,
- •Body mass index (BMI) more than 35 Kg/m2,
- •Patients with neck pathology
- •Pregnant females,
- •Patients at increased risk of gastric aspiration.
- •Laparoscopic surgery
- •Emergency surgery.
结局指标
主要结局
To compare oropharyngeal seal pressure (OLP) while using I-Gel and Baska mask at various time intervals
时间窗: To compare oropharyngeal seal pressure (OLP) while using I-Gel and Baska mask at various time intervals for 30 minutus
次要结局
- To compare the ease of insertion of each device in terms of time taken and number of attempts per device insertion.(To compare leak fraction by using either I-Gel or Baska mask.)
研究者
Dr Abhishek Joshi
All India Institute of Medical Sciences, Gorakhpur