Ultrasonographic Comparison of Gastric Volume After Three Modes of Positive Facemask. A Prospective Randomized Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Gastric volume before and after positive pressure ventilation
研究概览
简要总结
This study is designed to evaluate the occurrence of gastric insufflation and the critical volume of the stomach after three different modes of positive pressure ventilation during induction (Manual-controlled, volume-controlled and pressure-controlled ventilation)
详细描述
Aspiration of gastric contents can be a serious perioperative complication, which can be related to facemask positive pressure ventilation with unprotected airway. Even with low peak airway pressure (<15 cm H2O) gastric insufflation may occur. Since gastric content and volume assessment is a new point-of-care ultrasound recommended application, the cross-sectional antra area will be measured using ultrasonography before, continuously during facemask ventilation and after intubation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •ASA status I and II
排除标准
- •Pregnant woman Obese patient (BMI>30kgm-2) oropharyngeal or facial anomalies anticipated difficult mask ventilation upper respiratory tract infection history of gastric surgery patient refusal
研究组 & 干预措施
Manual-controlled
Patient in the manual ventilation group will receive facemask ventilation to get a tidal volume of 8-10ml/kg with a respiratory rate of 15/min. The pop-off valve will be set to 20 cm H2O.
干预措施: Diagnostic ultrasonography of gastric volume (Other)
Volume-controlled
mechanical breath will be delivered by a Primus ventilator (Dräger, Lubeck, Germany) at a frequency of 15 breath/min. Tidal volume will be set to 8-10 ml/min.
干预措施: Diagnostic ultrasonography of gastric volume (Other)
Pressure-controlled
mechanical breath will be delivered by a Primus ventilator (Dräger, Lubeck, Germany) at a frequency of 15 breath/min. Pressure will be adjusted to obtain a tidal volume of 8-10 ml/min.
干预措施: Diagnostic ultrasonography of gastric volume (Other)
结局指标
主要结局
Gastric volume before and after positive pressure ventilation
时间窗: 15 minutes
次要结局
- Ultrasonographic detection of gastric insufflation during ventilation(15 minutes)
研究者
LAFERE Pierre
Docteur Pierre Lafère
University Hospital, Brest