A randomized coparativesuty of AmbuAuraGain Vs BlockBuster Laryngeal Mask for controlled ventilation in paediatric laparoscopic surgeries under general anaesthesia in Department of Anaesthesia, S.M.S Medical College and Attached hospitals, Jaipur.
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 64
- 试验地点
- 1
- 主要终点
- 1.The difference in Oropharyngeal Leak Pressure between the two supraglottic devices immediately after insertion and 10 minutes after pneumoperitoneum creation.
研究概览
简要总结
Supraglottic airway devices are an established part of routine and emergency pediatric airway management, including use in difficult airways and neonatal resuscitation. Since their introduction into medical practice, supraglottic airway devices have proven safe and efficient in various settings. The BlockBuster laryngeal mask (LM) has shown to have higher oropharyngeal leak pressure in adults ) and children. Ambu AuraGain has shown its efficacy in pediatric anesthesia compared with other second-generation supraglottic airway devices. The comparison studies between the BlockBuster LM and Ambu AuraGain are lacking in pediatric laparoscopic surgeries hence this study is proposed to compare the ventilatory effectiveness of the above mentioned two supraglottic devices in controlled ventilation during pediatric laparoscopic 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
- 1.00 Year(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •1 ASA physical statuses 1 and 2 2 Undergoing elective laparoscopic surgeries.
- •3 Informed written consent from parent/guardian for the study.
排除标准
- •Syndromic children with difficult airway, intraoral pathology.
- •Patients who had recent respiratory tract infections.
- •Patients with risk of aspiration.
- •Patient should not be part of any other study.
- •Non cooperative patient.
结局指标
主要结局
1.The difference in Oropharyngeal Leak Pressure between the two supraglottic devices immediately after insertion and 10 minutes after pneumoperitoneum creation.
时间窗: 1. Oropharyngeal leak pressure is checked immediately and 10mins after pneumoperitoneum creation | 2. Ventilatory parameters: Immediately after insertion of LMA, after patient positioning, after preumoperitoneum creation, 10mins after preumoperitoneum creation
2.The difference in ventilatory parameters (tidal volume, respiratory rate, leak and peak airway pressure) between the two supraglottic devices.
时间窗: 1. Oropharyngeal leak pressure is checked immediately and 10mins after pneumoperitoneum creation | 2. Ventilatory parameters: Immediately after insertion of LMA, after patient positioning, after preumoperitoneum creation, 10mins after preumoperitoneum creation
次要结局
- 1.To determine the differences in insertion characteristics between the two supraglottic devices in terms of time taken for insertion of device, number of attempts taken & ease of insertion.(2.To determine the difference in fiberoptic grading of glottis in both the groups.)
研究者
Dr. Gayatri Appat B
JK LONE HOSPITAL, UNDER SAWAI MAN SINGH MEDICAL COLLEGE AND HOSPITAL