Comparison of gastric insufflation with pressure and volume controlled face mask ventilation in children: A Randomized controlled study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 68
- 试验地点
- 1
- 主要终点
- the incidence of Gastric insufflation during pressure controlled and volume controlled face mask ventilation
研究概览
简要总结
Face mask ventilation is a basic skill and is especially more important in children as they are more prone to hypoxia related injuries. Gastric insufflation is a known side effect during face mask ventilation , and children are at risk due to their shorter esophagus and lower LES tone, can lead to backflow of stomach contents leading to pulmonary and hemodynamic complications. Gastric ultrasound is found superior to other methods to look for insufflation. There is currently no evidence indicating PCV superior to VCV regarding gastric insufflation in children, therefore we aim to conduct a prospective randomized trial comparing PCV with VCV, with respect to gastric insufflation and adequacy of ventilation. children meeting both inclusion and exclusion criteria will be taken. Preoperatively , gastric u;trasoung will be done, after standard induction process , facemask ventilation will be done for 4 minutes in either of the two modes of ventilation either VCV or PCV . respiratory, hemodynamic and ventilaory parameters will be monitored every min till intubation. Insufflation will be seen by either comet tail appearance or acoustic shadow on gastric ultrasound and antra area is also taken post intubation. incidence of gastric insufflation will be calculated ass the primary outcome and antral area difference and repiratory, hemodynamic and ventilatory parameters are compared as secondary outcomes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 1.00 Year(s) 至 3.00 Year(s)（—）
- 性别
- All
入选标准
- •ASA PS- 1 and 2, aged between 1-3years, of either gender undergoing elective surgery, after parent/guardian consent would be enrolled.
排除标准
- •Anticipated difficult face mask ventilation Parents refusal Underlying respiratory or gastric disease Inadequate fasting status Those requiring rapid sequence intubation Those with a nasogastric tube insitu.
结局指标
主要结局
the incidence of Gastric insufflation during pressure controlled and volume controlled face mask ventilation
时间窗: immediately after intubation
次要结局
- gastric antral area(preoperative room and after intubation)
- Hemodyanamic parameters including mean arterial pressure and heart rate(At 1min, 2min, 3 min, 4 min and post intubation)
- Ventilation parameters including peak airway pressures, inspired tidal volume, expired tidal volume, minute ventilation(at 1min, 2min, 3 min, 4 min and post intubation)
- Respiratory parameters including end tidal carbon dioxide, oxygen saturation(at 1min, 2min, 3 min, 4 min and post intubation)
- any desaturation, inability to ventilate, episodes of vomiting or regurgitation(induction to after intubation)
研究者
Dr Anusha Manikyam
Post Graduate Institute of Medical Education and Research