Comparison of clinical performance of Blockbuster® Laryngeal mask airway and Proseal ® Laryngeal mask airway in anaesthetised children below 7 years- A randomised controlled trial.
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 入组人数
- 32
- 试验地点
- 1
研究概览
简要总结
Endotracheal intubation is the definitive airway for ventilation and prevention of aspiration during general anaesthesia, but the invention of supraglottic airway devices has changed the focus of airway management during general anaesthesia from intubation to oxygenation and ventilation.The use of supraglottic airway devices for securing the airway in paediatric patients undergoing surgery has become popular thereby decreasing the perioperative airway complications.However safety and clinical performance of these devices has still not been properly established in paediatric population.The aim of the study is to compare the efficacy of Blockbuster® Laryngeal mask airway and Proseal® Laryngeal mask airway. It is a Prospective Single blinded Randomised Controlled study. After obtaining Institution Ethics Committee approval pediatric patients who fit into the inclusion criteria will be enrolled into the study after obtaining informed consent from the parents. Patients will be randomly allocated into two groups by using computer generated block randomization table. Group A- Blockbuster LMA Group B – Proseal LMA.Baseline vitals – heart rate, oxygen saturation, and blood pressure will be monitored.After three minutes of preoxygenation the lubricated supraglottic airway device (SGA) will be inserted into child’s mouth with head in neutral position as per the allocated group.The appropriate size of the SGA device will be selected as per the manufacturer’s recommendation.Cuff of the device will be inflated with adequate volume of air as per the manufacturer’s recommendation. After confirmation of the position of the supraglottic airway device it will be fixed and connected to the ventilator with appropriate ventilator settings and the required depth of anaesthesia will be maintained.Then the oropharyngeal leak pressure will be measured,which is defined as the pressure in the anaesthesia breathing circuit at which gas leak occurs around the Supra glottic airway device.To ensure safety, maximum allowable Oropharyngeal seal pressure will be set at 40 cm H2O, and adjustable pressure limiting valve pressure will be released if there is no audible leak even at maximum allowable pressure. Mean Insertion time,Ease of supraglottic airway device insertion,Fibreoptic view of vocal cord through the LMA ,Ease of gastric tube placement ,The presence of blood on the device at the end of removal will also be noted.The parameters observed will be compared between the two groups and statistical analysis will be done.This study will help compare the clinical performance of two different airway devices in pediatric population.
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
- 1.00 Year(s) 至 7.00 Year(s)(—)
- 性别
- All
入选标准
- •Children of age group 1 to 7 years of either gender American Society of Anaesthesiologist physical status I and II scheduled for elective surgery under general anaesthesia.
排除标准
- •Anticipated difficult airway Syndromic children Children with upper and lower respiratory tract infections Distorted upper airway anatomy or upper airway obstruction Children undergoing emergency surgery Risk of Aspiration(full stomach, history of stomach surgery, hiatal hernia etc).
研究者
Gauthamme Sai L M
Sri Ramachandra medical College and research Institute
