To compare the leak volume with and without the application of positive end-expiratory pressure with I-gel based general anaesthesia in pediatric patients: A Randomised Control Trial
试验速览
- 阶段
- Phase 3 4
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 1
- 主要终点
- To compare the leak volume with and without the application of positive end expiratory pressure with I-gel based general anaesthesia in pediatric patients
研究概览
简要总结
The term positive end expiratory pressure (PEEP) refers to pressure in the airway at the end of passive expiration that exceeds atmospheric pressure. The use of PEEP has mainly been reserved to recruit or stabilise lung units and improve oxygenation in patients. I-gel is an innovative second generation supraglottic airway device, designed to create a non-inflatable, anatomical seal of the pharyngeal, laryngeal, and perilaryngeal structures whilst avoiding compression trauma. Although there are numerous adult studies on the effectiveness and safety of I-gel with and without PEEP pressure, we sought to assess the same efficacy in children. This study is a one year randomised control trial.
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
- 2.00 Day(s) 至 12.00 Day(s)（—）
- 性别
- All
入选标准
- •Age 2 to 12 years of age ASA l and ll Elective Surgeries Consent given.
排除标准
- •Airway deformities (congenital) Risk of aspiration Preoperative sore throat or upper respiratory tract infection Allergy to local anaesthetic.
结局指标
主要结局
To compare the leak volume with and without the application of positive end expiratory pressure with I-gel based general anaesthesia in pediatric patients
时间窗: To compare leak volume at intervals of 5 minutes, 30 minutes, and 1 hour.
次要结局
- To compare end tidal carbon dioxide and peak inspiratory pressure with I-gel based general anaesthesia in paediatric patients(To compare end tidal carbon dioxide and peak inspiratory pressure at intervals of 5 minutes, 30 minutes, and 1 hour.)
研究者
Dr Sriya V Tallapragada
KAHERs Jawaharlal Nehru Medical College