To evaluate the efficacy of Baska mask and LMA Protector in anesthetized paralysed patients – a prospective randomized comparative study.
试验速览
- 阶段
- Unknown
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- Oropharyngeal leak pressure during positive pressure ventilation.
研究概览
简要总结
The supraglottic airway devices (SGAD) are widely used for airway management in anaesthetic field, critical care and emergency situations like difficult airway management. Since their introduction, several innovative devices have been developed depending on shape, functioning channels and cuff.
Baska maskTM (BM) is novel SGAD with self-sealing membranous cuff that inflates during inspiration and partially deflates during expiration. It has two drain channels proximally, opening into the large integral sump cavity distally, at the upper oesophagus.
LMA-Protectorâ„¢ is relatively new SGAD with inflatable cuff integrated with Cuff Pilotâ„¢ technology for easier and continuous adjustment of the intracuff pressure. Similar to BM, it has two drain channels which narrows distally into common orifice communicating with the upper oesophageal sphincter.
Both the devices had been evaluated in limited studies. The two devices are similar in design except cuff. BM has got self-sealing cuff while LMA protector has inflatable cuff with continuous monitoring of cuff pressure, so we hypothesize that oropharyngeal sealing pressures might be comparable. Currently, there is no available literature comparing the efficacy of BM with LMA protector.
In our study, we aim to compare BM and LMA protector in terms of clinical efficacy like adequacy of airway seal, insertion time, ease and accuracy of insertion, and the incidence of postoperative sore throat and other complications, in paralyzed and anesthetized patients.
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
- •18- 65 years all patients Scheduled for elective surgery under general anaesthesia in supine position with expected duration of surgery less than 2 hours.
排除标准
- •Upper airway anatomic variation or pathology.
- •Predicted difficult airway
- •High risk of aspiration (full stomach, gastroesophageal reflux, Pregnancy)
- •Body mass index greater than 30 kg/m2,
- •Patient refusal to participate.
结局指标
主要结局
Oropharyngeal leak pressure during positive pressure ventilation.
时间窗: it will be assessed only once immediately after insertion and once successful ventilation is confirmed.
This outcome measure was used for sample size calculation.
时间窗: it will be assessed only once immediately after insertion and once successful ventilation is confirmed.
次要结局
- 1. First attempt success rate.(2. Accuracy of size as per manufacturer recommendation.)
研究者
Dr Ruchi Saxena
Kalyan Singh Superspeciality Cancer Institute
