A comparison of I-Gel versus laryngeal mask airway(LMA) supreme for elective short surgical procedures under general anaesthesia with spontaneous ventilation in paediatric patients.
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To compare the efficacy and safety of I-GEL versus LMA SUPREME for elective short surgical proceduresunder general anaesthesia with spontaneous ventilation in paediatric patients in terms of insertion time ,ease of insertion andnumber of attempts
研究概览
简要总结
Airway management is fundamental component of successful anaesthesia practice. endotracheal intubation is th gold standard for securing airwy in anaesthetized patient . Inroduction of supraglottic airway devices (SGAs) represented a signifant advancement in airway management developed by Dr Archie Brain in 1988. It eliminated the requirement of laryngoscopy and reduced the dependance on muscle relaxants.
In paediatric patients , supraglottic airway (SGA) devices are commonly used for a variety of short and minimally invasive surgeries. They have easier and faster placement , less airway trauma, reduced hemodynamic response, and smoother recovery . while they offer disadvantages like they do not protect the airway as effectively as endotracheal tubes .
I-GEL has non inflatable cuff that provides a reliable seal , reducing the risl of airway trauma compared to traditional endotracheal intubation
LMA SUPREME has inflatable cuff fo a tiht seal at larynx , reducing the risk of air leakage .
the I-GEL and LMA SUPREME are widely used , but mostly in adults with limited reserch comparing their effectiveness in paediatric patients who represent unique anatomical and physiological challenges . this study aims to bridge the gap in paediatric SGA research by comparing both devices in terms of ease of insertion , time required for insertion , airway stability and perioperative complications.
these findings will provide valueable insights for optimizing airway management strategies in paediatric patients undergoing short elective surgeries.
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
- 6.00 Month(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •All genders ASA Grading I,II Patient undergoing elective short surgeries for duration for 60-90 minutes under general anaesthesia.
排除标准
- •Non consenting parents Difficult airway ( MPC CLASS 3 or more) Presence of any disease or surgery of neck,upper respiratory tract and upper gastrointestinal tract Congenital airway abnormalities.
结局指标
主要结局
To compare the efficacy and safety of I-GEL versus LMA SUPREME for elective short surgical proceduresunder general anaesthesia with spontaneous ventilation in paediatric patients in terms of insertion time ,ease of insertion andnumber of attempts
时间窗: To compare the efficacy and safety of I-GEL versus LMA SUPREME for elective short surgical proceduresunder general anaesthesia with spontaneous ventilation in paediatric patients in terms of insertion time ,ease of insertion ,number of attempts and hemodynamics at different time intervals like baseline , at induction , after induction ,every 5 minutes after insertion of Supragottic airway device till 15 minutes .
次要结局
- To compare ease of insertion of gastric catheter.(An appropriate sized lubricated suction catheter will be passed through the gastric channel of device to prevent gastric insulation and ease of insertion will be recorded)
- To assess hemodynamic parameters.(Variation between the heart rate ,blood pressure respiratory rate ,spo2,and ETCO2 will be recorded before induction , after induction just after SGA insertion then after 5,10,15 minutes after insertion of device .)
- To compare perioperative complications.(Any complications during insertion of SGA like coughing, gagging ,regurgitation ,vomiting ,patients movement and trauma will be noted.)
研究者
Armaandeep Singh
Adesh Institute of Medical Sciences and Research