Comparison of LMA ProSeal and LMA ProtectorTM as airway device in laparoscopic surgeries - a randomized controlled trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 140
- 试验地点
- 1
- 主要终点
- primary outcome -oropharyngeal leak pressure
研究概览
简要总结
LMA ® Protector™ is a recently developed second generation supraglottic airway device that has been designed to provide superior protection
against gastric reflux and high OLP. It is a single use, silicone airway device. The silicone cuff conforms to the airway anatomy and achieves higher seal pressures and lesser sore throat compared to PVC cuffs.(2)(3) No studies till date have attempted to compare the efficacy of LMA®ProSeal and
LMA®Protector™. This study will therefore compare LMA®ProSeal and LMA®Protector™ as airway devices in laparoscopic surgeries. Use of an
airway device with better OLP and protection against regurgitation, lower sore throat will improve patient safety and perioperative outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA class 1 and 2 Patients undergoing laparoscopic surgeries Duration of surgery less than 4 h Expected blood loss less than 300 ml.
排除标准
- •Patients who deny consent Anticipated difficult airway Increased risk of aspiration (Full stomach , hiatus hernia , gastroesophageal reflux disease).
结局指标
主要结局
primary outcome -oropharyngeal leak pressure
时间窗: primary outcome -oropharyngeal leak pressure measured in both groups after insertion of LMA | Time to insertion of the LMA will be time from picking up LMA till first visualisation of EtC02 graph | Postoperative sore throat - assessed immediately postoperatively and on POD1 | Fiberoptic score for correct placement - done immediately after placement of the LMA
secondary outcome- Time to insertion of the LMA
时间窗: primary outcome -oropharyngeal leak pressure measured in both groups after insertion of LMA | Time to insertion of the LMA will be time from picking up LMA till first visualisation of EtC02 graph | Postoperative sore throat - assessed immediately postoperatively and on POD1 | Fiberoptic score for correct placement - done immediately after placement of the LMA
Postoperative sore throat
时间窗: primary outcome -oropharyngeal leak pressure measured in both groups after insertion of LMA | Time to insertion of the LMA will be time from picking up LMA till first visualisation of EtC02 graph | Postoperative sore throat - assessed immediately postoperatively and on POD1 | Fiberoptic score for correct placement - done immediately after placement of the LMA
Fiberoptic score for correct placement
时间窗: primary outcome -oropharyngeal leak pressure measured in both groups after insertion of LMA | Time to insertion of the LMA will be time from picking up LMA till first visualisation of EtC02 graph | Postoperative sore throat - assessed immediately postoperatively and on POD1 | Fiberoptic score for correct placement - done immediately after placement of the LMA
Ease of insertion
时间窗: primary outcome -oropharyngeal leak pressure measured in both groups after insertion of LMA | Time to insertion of the LMA will be time from picking up LMA till first visualisation of EtC02 graph | Postoperative sore throat - assessed immediately postoperatively and on POD1 | Fiberoptic score for correct placement - done immediately after placement of the LMA
Adverse airway complications
时间窗: primary outcome -oropharyngeal leak pressure measured in both groups after insertion of LMA | Time to insertion of the LMA will be time from picking up LMA till first visualisation of EtC02 graph | Postoperative sore throat - assessed immediately postoperatively and on POD1 | Fiberoptic score for correct placement - done immediately after placement of the LMA
peak airway pressures
时间窗: primary outcome -oropharyngeal leak pressure measured in both groups after insertion of LMA | Time to insertion of the LMA will be time from picking up LMA till first visualisation of EtC02 graph | Postoperative sore throat - assessed immediately postoperatively and on POD1 | Fiberoptic score for correct placement - done immediately after placement of the LMA
Patient satisfaction score
时间窗: primary outcome -oropharyngeal leak pressure measured in both groups after insertion of LMA | Time to insertion of the LMA will be time from picking up LMA till first visualisation of EtC02 graph | Postoperative sore throat - assessed immediately postoperatively and on POD1 | Fiberoptic score for correct placement - done immediately after placement of the LMA
Operator satisfaction score
时间窗: primary outcome -oropharyngeal leak pressure measured in both groups after insertion of LMA | Time to insertion of the LMA will be time from picking up LMA till first visualisation of EtC02 graph | Postoperative sore throat - assessed immediately postoperatively and on POD1 | Fiberoptic score for correct placement - done immediately after placement of the LMA
Cost effective analysis of the two devices
时间窗: primary outcome -oropharyngeal leak pressure measured in both groups after insertion of LMA | Time to insertion of the LMA will be time from picking up LMA till first visualisation of EtC02 graph | Postoperative sore throat - assessed immediately postoperatively and on POD1 | Fiberoptic score for correct placement - done immediately after placement of the LMA
次要结局
- secondary outcome- Time to insertion of the LMA(Postoperative sore throat)
研究者
Dr Aditi Suri
ALL india institute of medical sciences, new delhi