Para Tracheal Compression to Prevent Gastric Insufflation During Positive Pressure Ventilation With Facemask in Children Under General Anaesthesia: an Efficiency Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Presence of air artefacts during positive pressure ventilation as evaluated by simultaneous gastric ultrasonography
研究概览
简要总结
The use of cricoid pressure to prevent gastric aspiration or regurgitation in case of "full stomach" situation or emergency is still controversial in the adult population. Moreover this maneuver is no more recommended in children by some European pediatric anesthesia societies, because of a lack of evidence of its protective effect against gastric aspiration and its possible adverse effects.
A new approach to occlude effectively the esophageal lumen has been recently described in adults and has shown its effectiveness to prevent gastric insufflation. But this maneuver has so far not been evaluated in the pediatric population and could be an alternative to prevent gastro-esophageal regurgitation and pulmonary aspiration in children
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 2 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children from 2 to 10 years of age who benefit from general anesthesia with or without intubation
- •inhalation induction
- •elective surgery
- •ASA status 1 or 2
- •consent of the child if he/she is able to express it
- •consent of both parents and/or legal guardians
- •socially insured
排除标准
- •Child under 2 years old or > 10 years
- •body weight is over 40 kgs
- •ASA status 3 or higher
- •Emergency surgery or unscheduled surgery
- •scheduled ENT or esogastric surgery
- •Achalasia of the esophagus or history of GERD pathology
- •History of esophageal surgery (NISSEN type)
- •BMI indexed to age and sex showing childhood obesity
- •Predictable mask ventilation difficulties
- •History of Tracheostomy
- •Child not insured by social security
结局指标
主要结局
Presence of air artefacts during positive pressure ventilation as evaluated by simultaneous gastric ultrasonography
时间窗: We will perfom a unique measurement of gastric air artefact by ultrasonography after 2 minutes of positive pressure ventilation.
Presence of antral and/or gastric air artefact described in ultrasonography. US will be perform during positive pressure mask ventilation.
次要结局
- The safety of the LLPP maneuver: absence of any significant compression of the adjacent vessels as measured by US.(Before the beginning of positive pressure ventilation and during 1 minute)
- The verification of the actual position of the esophagus on the left side of the trachea at the place where LPPP will be applied (feasibility of LLPP)(Before the beginning of positive pressure ventilation during 1 minute)
- The expired tidal volume and peak inspiratory pressure as measured during PPV to evaluate any difficulty in mask ventilation induced by LLPP.(At the beginning of positive pressure ventilation and during two minutes)