Comparison Of Efficacy And Safety Between Endotracheal Tube And Laryngeal Mask Airway-ProsealTM Patients Undergoing Surgery In Prone Position - A Prospective, Randomised, Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Efficacy of PLMA in prone position
研究概览
简要总结
This study is a prospective, randomized, observational study comparing the safety and efficacy of endotracheal tube and Laryngeal Mask Airway – ProsealTM during a period between December 2015 and October 2017 in 48 patients that will be conducted in India. The primary outcome measures will be to see the efficacy of PLMA in prone position. The secondary outcomes will be to see the safety of PLMA in prone position.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Undergoing surgery in prone position
- •ASA physical status 1 to 3.
排除标准
- •Anticipated difficult airway
- •BMI ≥ 30
- •Patients not consenting for the study
- •Pregnancy or breast feeding females
- •Patients with present history of sore throat or dysphagia.
结局指标
主要结局
Efficacy of PLMA in prone position
时间窗: 0-supine | 1-prone | 2-30 minutes | 3-60 minutes
1.Leak pressure (cmH2O)
时间窗: 0-supine | 1-prone | 2-30 minutes | 3-60 minutes
2.Ventilatory characteristics assessed by Tidal volume (VT) (ml), Respiratory rate (RR) (cycles/min), Minute Volume (MV) (litres), Peak [Ppeak] and mean airway pressure [Pmean] (cmH2O), compliance (ml/cmH2O).
时间窗: 0-supine | 1-prone | 2-30 minutes | 3-60 minutes
次要结局
- Safety of PLMA in prone position(1.Number of attempts at insertion)