A randomised study comparing the clinical performance of three disposable supraglottic airway devices-I-gel, LMA Supreme and Ambu AuraGain in lateral position in pediatric patients undergoing surgery under general anesthesia.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Oropharyngeal seal pressures (cm H20) of Ambu AuraGain, LMA supreme, I-gel in lateral position using equilibrium airway pressure method, measured by reading (centimetres of H2O) displayed on ventilator screen (Drager Primus);
研究概览
简要总结
Supraglottic airway devices are better alternatives to endotracheal intubation for various reasons. The newer supraglottic airway devices namely - I-gel, LMA Supreme, Ambu Aura Gain, have shown promising results in adult and paediatric patients. In this study, we aim to compare the mentioned devices in lateral position. Once the anaesthesia is induced, alloted device will be inserted and the OSP (cm of H2O) will be measured in supine and lateral positions.
A standard anesthesia technique will be followed in all patients included in the study. Written informed consent and thorough preanesthetic evaluation will be done to ensure adherence to inclusion and exclusion criteria. The study will be conducted while routine induction of a case hence, will not require much time and surgeons will be allowed to proceed without much delay.
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 Month(s) 至 6.00 Year(s)（—）
- 性别
- All
入选标准
- •1 ASA I and II 2 Patients undergoing elective day care under general anaesthesia in which the choice of airway device has already been decided as a disposable second generation supraglottic airway device and who require lateral position intraoperatively 3 Weight more than 10 kgs up to 25-35 kgs.
排除标准
- •1.Difficult airway.
- •2.Active Upper respiratory tract infection (URTI) 3.Alimentary tract pathology 4.Cervical spine pathology Anticipated 5.Raised Intra-abdominal pressure.
结局指标
主要结局
Oropharyngeal seal pressures (cm H20) of Ambu AuraGain, LMA supreme, I-gel in lateral position using equilibrium airway pressure method, measured by reading (centimetres of H2O) displayed on ventilator screen (Drager Primus);
时间窗: Oropharyngeal seal pressures (cm H20) of Ambu AuraGain, LMA supreme, I-gel in lateral position using equilibrium airway pressure method, measured by reading (centimetres of H2O) displayed on ventilator screen (Drager Primus). The OSP will be checked at 10 mins after insertion , 1st minute after lateralisation, 5th minute after lateralisation
次要结局
- 1. To determine the OSP of the mentioned devices in supine position after 10 mins of insertion of the airway device(2.Time taken and number of attempts for insertion)
研究者
Dr Chitra
All India Institute of Medical Sciences, Bhopal