Evaluation and Comparison of insertion of LMA BlockBuster with i-Gel for airway management in children
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- To study and compare the time of insertion of the devices used
研究概览
简要总结
The study titled “Evaluation and Comparison of insertion
of LMA BlockBuster with i-Gel for airway management in children" will be conducted in the Department of Anaesthesiology and Critical Care, Pt. BD Sharma PGIMS, Rohtak. It will be a prospective randomised single blinded trial. A total of 50 pediatric patients undergoing elective surgical procedure under general anaesthesia belonging to the age group of 8 to 12 years of either gender will be allocated into 2 groups of 25 patients each- group BB (for LMA BlockBuster) and group I (for i-Gel). After taking informed and written consent from the parents/ guardians the patients will be induced for general anaesthesia as per standard guidelines and the device of appropriate size will be used to secure the airway for maintenance throughout the surgery. A fiberoptic bronchoscope will then be passed through the device to check the Cormack- Lahane grading. All the vital observations will be recorded in the record sheet. After the completion of the surgery, the patient will be reversed from general anaesthesia and post-operative complications like blood staining of the device, laryngospasm, sore throat, cough and hoarseness of voice will be observed and managed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 8.00 Year(s) 至 12.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA category 1 or 2 with MPG I or II undergoing elective surgical procedures under general anaesthesia will be included in the study and appropriate size of the airway devices will be used.
排除标准
- •Abnormal airway, refusal for informed written consent by the parent/ guardian, inadequate mouth opening (less than 2 finger breadth).
结局指标
主要结局
To study and compare the time of insertion of the devices used
时间窗: Measured during induction of general anaesthesia
次要结局
- Oropharyngeal leak pressure(assessed at baseline)
- Number of attempts(Assessed at baseline)
- Ease of insertion(Assessed at baseline)
- Fiberoptic view scoring(Assessed at baseline)
- Blood stain, Laryngospasm, sore throat, cough, hoarseness of voice(Measured at extubation & at 1 hour, 3 hours & 6 hours post-operative period)
研究者
Dr Rajmala Jaiswal
Pt. BD Sharma PGIMS, Rohtak