Comparison of oropharyngeal leak pressure of Proseal Laryngeal mask airway and i-gel plus at head rotation; a randomised controlled study.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 154
- 试验地点
- 1
- 主要终点
- Mean oropharyngeal leak pressure of Proseal Laryngeal mask airway and i-gel plus at 60° head rotation using manometer stability technique.
研究概览
简要总结
We are comparing oropharyngeal leak pressure (OLP) of two supraglottic airway devices- Proseal Laryngeal Mask Airway (PLMA) and i-gel Plus in adult patients under general anaesthesia with head positions at 0°, 30°, and 60° rotation. The aim of study is to compare oropharyngeal leak pressure of Proseal laryngeal mask airway and i-gel plus in head rotated positions. A total of 154 ASA I–III patients (18–60 years, BMI 19–30 kg/m²) will be randomized into PLMA and i-gel Plus groups. Standardised anaesthetic induction and device insertion will be performed, with measurements taken at each head position. OLP will be determined by manometer stability technique and fibreoptic views will be graded by Brimacombe score. Adverse outcomes such as sore throat or blood staining of device will be noted.
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
- •American Society of Anaesthesiologists physical status (ASA) I-III BMI (Body Mass Index) 19-30 Kg/m².
排除标准
- •Any risk of gastric aspiration.
- •Underlying respiratory diseases.
- •Restricted neck movements.
结局指标
主要结局
Mean oropharyngeal leak pressure of Proseal Laryngeal mask airway and i-gel plus at 60° head rotation using manometer stability technique.
时间窗: 5 minutes after the placement of device.
次要结局
- 1. Mean oropharyngeal leak pressure of Proseal Laryngeal mask airway and i-gel plus at 0°, 30° head rotation using manometer stability technique.(2. Fibreoptic view of vocal cords through Proseal Laryngeal mask airway and i-gel plus at 0°, 30° and 60° head rotation using Brimacombe score.)
研究者
Vandana kumari
Maulana Azad Medical College