Effect of oropharyngeal airway on gastric insufflation during anesthetic induction in children- a randomized controlled study
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 188
- 试验地点
- 1
研究概览
简要总结
Gastric insufflation (GI) is a known complication of facemask ventilation during anaesthetic induction, particularly in paediatric patients. During this process, the application of positive pressure may inadvertently direct gas into the stomach, leading to risks such as aspiration, impaired ventilation, and increased intragastric pressure. Despite the use of pressure-controlled ventilation (PCV) techniques designed to limit peak airway pressures, the risk of GI persists. The oropharyngeal airway (OPA) is a simple adjunct that may help mitigate GI by maintaining upper airway patency and reducing resistance during facemask ventilation. However, few studies have directly assessed its impact on GI during anaesthetic induction in children. This study seeks to bridge a significant knowledge gap by evaluating whether the use of an oropharyngeal airway can reduce the incidence of gastric insufflation during pressure-controlled mask ventilation in paralyzed paediatric patients. The secondary outcomes investigated are as follows:
a) Determine the appropriate level of inspiratory pressure sufficient to provide adequate ventilation with or without an OPA a during facemask pressure-controlled ventilationb) To compare time for appearance of comet tail on real time US between the two groups
c) To compare hemodynamic parameters and ventilatory parameters between the two groups.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Outcome Assessor Blinded
入排标准
- 年龄范围
- 15.00 Month(s) 至 18.00 Year(s)(—)
- 性别
- All
入选标准
- •Age group: children more than 60 weeks (post conceptional age) 2) Weight less than 30kg 3) American Society of Anesthesiologists (ASA) Physical status (PS) I and II status 4)Children undergoing elective surgery under general anaesthesia.
排除标准
- •Full stomach status 2) Anticipated difficult mask ventilation 3) Contraindication for OPA insertion (oral mass) 4) Upper airway obstruction risk – grade 3 and above tonsils, symptoms of snoring or suggestive of obstructive sleep apnea (OSA) 4) Obesity (more than 95% weight for age) 5) Known underlying respiratory disease or neurological disease 6) Known underlying significant cardiac disease.
研究者
Dr Mariyam Hudha
Kasturba Medical College, Manipal
