COMPARISON OF BLOCKBUSTER LARYNGEAL MASK AIRWAY WITH SUPREME LARYNGEAL MASK AIRWAY IN PAEDIATRIC PATIENTS: A PROSPECTIVE RANDOMIZED CLINICAL STUDY
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- To compare the oropharyngeal leak pressure between the two devices.
研究概览
简要总结
Airway management is an essential skill in Paediatric anaesthesia. A challenging airway, inadequately prepared for, or sub-optimally managed, can be a determining factor in morbidity and mortality in paediatrics. The Laryngeal Mask Airway (LMA) and other supraglottic airway devices has led to important changes in airway management in routine as well as emergency procedures.
Paediatric age group poses a variety of facial, oral and pharyngeal anatomical variations and all of this can contribute to difficulty in airway management. Apart from this, regional anaesthesia cannot
be solely done in paediatric age group due to incorporation by the patient and henceforth Supraglottic airway devices serves primary as well as a rescue device and as a conduit for endotracheal intubation when managing patients with a difficult airway.
There are several advantages of using SGAs over endotracheal tube intubation which includes quicker and easier placement, reduction in neuromuscular blocking drug usage, anaesthetic requirement for device placement, emergence coughing, and laryngeal and subglottic trauma, and preservation of laryngeal competence and mucociliary function
The LMA SUPREME is a single use device available in all sizes. It has a rigid curved airway tube, a drain tube positioned within the centre of the airway tube and a larger cuff made of polyvinyl chloride. Its rigid and curved design allows for placement without the need for digital guidance or assistance with other equipment, a potential benefit for inexperienced users. Also it is more suitable when the option for gastric access is needed in children.
A newer LMA called Tourens BlockBuster® LMA invented in 2012 for adults has been gaining popularity to provide increased safety and quality of anaesthesia. It is advantageous in providing ventilation and a channel for intubation.
Currently there are no studies regarding the use of LMA BLOCKBUSTER in paediatric age group. and henceforth in this prospective study we shall be comparing the performance of blockbuster LMA with supreme LMA in paediatric patients.
In this we hypothesise that the OLP of LMA BLOCKBUSTER is better than OLP of LMA SUPREME
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •WEIGHT 10KGS.
- •20 KGS AMERICAN SOCIETY OF ANAESTHESIOLOGY (ASA) PHYSICAL STATUS 1 -
- •SCHEDULED FOR ELECTIVE SURGERY UNDER GENERAL ANAESTHESIA REQUIRING SUPRAGLOTTIC DEVICE INSERTION.
排除标准
- •PARENTS OR LEGAL GUARDIAN OF THE PATIENT NOT CONSENTING.
- •PATIENTS WITH LARYNGEAL OR PHARYNGEAL PATHOLOGY.
- •KNOWN OR ANTICIPATED DIFFICULT AIRWAY ACTIVE RESPIRATORY TRACT INFECTION ON THE DAY OF SURGERY.
- •RISK OF ASPIRATION.
结局指标
主要结局
To compare the oropharyngeal leak pressure between the two devices.
时间窗: 5 minutes
次要结局
- •To compare the time taken for insertion of the devices.(•To compare the number of attempts taken for insertion)