Impact of Early Enteral vs. Parenteral Nutrition on Risk of Gastric-Content Aspiration in Patients Requiring Mechanical Ventilation and Catecholamines: an Ancillary Study of the NUTRIREA2 Trial (NCT01802099)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 139
- 试验地点
- 11
- 主要终点
- proportion of patients with abundant microaspiration (defined as a pepsin level >200 ng/mL in at least 30% of tracheal aspirates)
研究概览
简要总结
To evaluate the impact of enteral nutrition on microaspiration of gastric content and pharyngeal secretions
详细描述
A common obstacle to enteral nutrition is gastrointestinal intolerance, with regurgitations potentially responsible for gastric-content aspiration. Several studies involving technetium 99m (99mTc) labeling of gastric contents have established that gastric-fluid microaspiration is common in critically ill patients receiving both endotracheal ventilation and enteral nutrition. However, to our knowledge, no studies have specifically addressed the role for enteral nutrition in the occurrence of microaspiration. The objective of this ancillary study is to compare the frequency of gastric-content microaspiration in patients given enteral versus parenteral nutrition during the NUTRIREA2 trial. The new knowledge of risk factors for microaspiration provided by this study may help to improve strategies for preventing microaspiration and ventilator-associated pneumonia (VAP).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Invasive mechanical ventilation expected to be required more than 48 hours
- •Nutrition started within 24 hours after initiation of endotracheal mechanical ventilation
- •Treatment with vasoactive drug administered via a central venous catheter
- •Age over 18 years
- •Signed information
排除标准
- •Abdominal surgery within 1 month before inclusion
- •History of esophageal, gastric, duodenal or pancreatic surgery
- •Bleeding from the esophagus, stomach or bowel
研究组 & 干预措施
Parenteral nutrition
Patients will receive parenteral nutrition during the first week of mechanical ventilation. After Day 3, the parenteral route may be switched to the enteral route if shock resolve (vasoactive drug stopped since 24 hours and serum lactate level < 2 mmol/l). After Day 7, all patients will be fed via the enteral route.
干预措施: Parenteral nutrition (Other)
Enteral nutrition
Patients will receive nutrition only via the enteral route during the firs week of invasive mechanical ventilation.
干预措施: Enteral nutrition (Other)
结局指标
主要结局
proportion of patients with abundant microaspiration (defined as a pepsin level >200 ng/mL in at least 30% of tracheal aspirates)
时间窗: 48Hours following randomisation
Every tracheal aspirate will be collected during 48hours following randomisation
次要结局
- Salivary amylase levels in tracheal aspirates.(48Hours following randomisation)