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临床试验/NCT01267565
NCT01267565已完成不适用

Tracheal Dosage of Amylase : a New Surrogate for Microaspirations in Ventilated ICU Patients

Université Victor Segalen Bordeaux 22 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2010年9月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
40
试验地点
2
主要终点
oral/tracheal amylase ratio

研究概览

简要总结

Microaspirations of the oropharyngeal ± gastric contents through the endotracheal tube cuff contribute to the constitution of VAP. The pepsin has been recently proved effective as a surrogate of gastric content and was assessed in tracheal secretions. However, the pepsin dosage is fastidious, expensive and only characterizes aspirations from gastric origin. The aim of our study is to asses whether the value of amylase, which is mostly secreted by salivary glands, may turn out to be a new and simpler surrogate for microaspirations in ventilated ICU patients. Thirty patients ventilated for an anticipated length > 48h whose endotracheal tube includes a subglottic secretion device and producing sufficient endotracheal aspirations will be included. From H48, 4 sets of 3 aspirations each (oral, subglottic, tracheal) will be performed during one ventilation day for amylase dosage purpose. In ten of these patients, a comparison between pepsin and amylase will be assessed. In addition, 10 non intubated patients with an indication to bronchoscopy and necessitating a tracheal aspiration during the procedure will be included as a control group. The primary assessment criteria will be the oral/tracheal amylase ratio.

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
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

入选标准

  • intubated and ventlated patients group: patients ventilated with a tube including a subglottic secretion device for an anticipated length > 48h and producing sufficient endotracheal aspirations
  • non intubated patients group: patients with an study-independant indication to bronchoscopy and necessitating a tracheal aspiration during the procedure

排除标准

  • patients ventilated for less than 48h
  • patients developing ventilated-acquired pneumonia or bronchitis before potential inclusion
  • paralysed patients
  • patients requiring a closed suction device
  • patients with relative contraindications to endotracheal aspiration (status asthmaticus, severe ARDS with PF ratio < 100, hemorragic risk, brochopleural fistula)
  • bronchiectasis, cystic fibrosis
  • moribund patient or ethical decision to withhold or withdraw intensive care.

结局指标

主要结局

oral/tracheal amylase ratio

时间窗: up to 24h after bronchoscopy

次要结局

未报告次要终点

研究者

发起方
Université Victor Segalen Bordeaux 2
申办方类型
Other
责任方
Principal Investigator
主要研究者

Alexandre Boyer

M.D.

Université Victor Segalen Bordeaux 2

研究点 (2)

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