Diagnosis of Microaspiration in Intubated Critically Ill Patients: Pepsin vs 99m Technetium
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- incidence of pepsin levels ≥200 ng / ml
研究概览
简要总结
Microaspiration of contaminated oropharyngeal secretions and gastric contents frequently occurs in intubated critically ill patients, and plays a major role in the pathogenesis of ventilator-associated pneumonia. Quantitative pepsin measurement in tracheal aspirates would be useful in diagnosing microaspiration of gastric contents in intubated critically ill patients. Technetium 99m labelled enteral feeding is the gold standard for the diagnosis of microaspiration. The investigators hypothesized that tracheal pepsin measurement is a good diagnosis marker of microaspiration compared to the gold standard.
详细描述
Microaspiration of contaminated oropharyngeal secretions and gastric contents frequently occurs in intubated critically ill patients, and plays a major role in the pathogenesis of ventilator-associated pneumonia Quantitative pepsin measurement in tracheal aspirates would be useful in diagnosing microaspiration of gastric contents in intubated critically ill patients Technetium 99m labelled enteral feeding is the gold standard for the diagnosis of microaspiration. We hypothesized that tracheal pepsin measurement is a good diagnosis marker of microaspiration compared to the gold standard
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- •age > or = 18 years
- •hospitalised in ICU
- •tracheal intubation using a polyvinyl chloride tube and mechanical ventilation
- •predictable mechanical ventilation > or = 6 hours after inclusion
- •enteral nutrition by a nasogastric tube
排除标准
- •refuse to participate to the study
- •no informed consent
- •contra-indication for enteral nutrition
- •tracheotomy
- •intubation or re-intubation done in 6 hours preceding the inclusion
结局指标
主要结局
incidence of pepsin levels ≥200 ng / ml
时间窗: from the start to 6 hours after beginning of 99m technetium labelled enteral feeding
Sensibility and sensitivity of Pepsin for the diagnosis of microaspiration will be determined with regard to 99m technetium (gold standard).
次要结局
- likelihood ratio of pepsin of microaspiration(from the start to 6 hours after beginning of 99m technetium labelled enteral feeding)
- likelihood ratio of pepsin of microregurgitation(from the start to 6 hours after beginning of 99m technetium labelled enteral feeding)
- ROC curve(from the start to 6 hours after beginning of 99m technetium labelled enteral feeding)
- Youden Index(from the start to 6 hours after beginning of 99m technetium labelled enteral feeding)