Comparison of gastric insufflation volume between Baska mask and ProSeal Laryngeal mask airway in patients undergoing elective surgeryA randomized controlled trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 65
- 试验地点
- 1
- 主要终点
- To compare the gastric insufflation volume, assessed by ultrasound guided measurement of change in gastric antral cross-sectional area from baseline between Baska LMA and LMA ProSeal in patients scheduled for elective surgery under general anesthesia.
研究概览
简要总结
Laryngeal mask airways are the supraglottic airway devices,which are lesser invasive,can be used to give general anaesthesia during surgical procedure.But problem with supraglottic devices risk of aspiration.
In this study comparing the gastric insufflation between baska mask and LMA proseal.
after randomisation LMA inserted by the trained anaesthetist.Baseline gastric antral volume is measured before inserting the LMA and gastric distension is measured upto 5minutes after insertion obsering frosted glass sign/comet tail artefacts,and gastric antral volume measured at the end of surgery.
other parameters which are documented during the study are time taken to insert the LMA indcates which will be easy to insert,oropharyngeal sealing pressure shows maximum pressure that cuff seal can tolerate above that leak will be there,
comparison of gastric insufflation and peak airway pressure
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA-classification 1 and 2 patients scheduled up to 4 hours of elective surgery under general anaesthesia.
排除标准
- •1.Patient refusal 2.Potentially full stomach patients, requiring RSI 3.Obese patients with BMI > 30 kg/m2 4.Patients with upper gastrointestinal diseases, GERD 5.Upper gastro intestinal surgery 6.Patients with anticipated difficult mask ventilation or intubation 7.Pregnant females.
结局指标
主要结局
To compare the gastric insufflation volume, assessed by ultrasound guided measurement of change in gastric antral cross-sectional area from baseline between Baska LMA and LMA ProSeal in patients scheduled for elective surgery under general anesthesia.
时间窗: gastic insufflation is by ultrasound,intially a baseline data is measured, followed by antral CSA measured from point of LMA insertion upto 5minutes after insertion and also antral CSA measured at the end of surgery
次要结局
- Comparison of oropharyngeal cuff leak pressure with positive pressure ventilation after insertion of Baska mask with that of LMA proseal.(oropharyngel leak pressure is measured after 5mins of LMA insertion.)
- comparison of time taken to insert both devices.(time taken to insert LMA from the point of stoping the ventilation to the point of starting the ventilation after lma insertion)
- correlation of gastric insufflation and peak airway pressures(comparing gastric insufflation and peak airway pressure between two LMA.weather there is increase or not in airways pressure during gastric insufflation)