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临床试验/NCT03182387
NCT03182387已完成不适用

Evaluation du Dosage de l'Amylase Dans le Liquide Broncho Alveolaire Dans le Diagnostic précoce de la Pneumopathie d'Inhalation Infectieuse du Sujet Comateux intubé-ventilé.

University Hospital, Bordeaux1 个研究点 分布在 1 个国家目标入组 69 人开始时间: 2017年8月21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
69
试验地点
1
主要终点
Sensitivity and specificityof amylase test.

研究概览

简要总结

To evaluate the diagnostic performance of amylase assay performed from bronchial alveolar fluid to differentiate aseptic chemical inhalation pneumonitis from an infectious inhalation pneumonitis in comatose patients with intubated ventilation for less than 24 hours.

详细描述

Validation of the potential diagnostic performance of amylase assay compared to gold standard in diagnosis of infectious inhalation pneumonia of the comatose patient enabling the realization of a multicentric study using this innovative method in a diagnostic strategy with the objective of reducing the consumption of antibiotics.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

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

  • Patient intubated ≤ 24 hours for unconsciousness (stroke, meningitis, drug intoxication, metabolic disorders, epilepticus, cardiac arrest).
  • Inhalation table with hypoxemic acute respiratory insufficiency post-consciousness + chest x-ray revealing one or more compatible infiltrates + t °> 38 ° C).
  • Age ≥18 years
  • Patient affiliated to the social security system.
  • No opposition obtained

排除标准

  • Immunocompromised patient.
  • Cardiorespiratory arrest requiring therapeutic hypothermia.
  • Pneumopathy nosocomiale (pneumopathy beginning> 48h after hospital admission).
  • Infectious Pneumonia in the previous 30 days.
  • Previous hospitalization in the previous 30 days.
  • Patient under antibiotic at baseline.
  • Bacteremia.
  • Mechanical ventilation begun before unconsciousness.
  • Report Pa02 / FI02 <
  • Patient under curatorship and / or guardianship.

结局指标

主要结局

Sensitivity and specificityof amylase test.

时间窗: 5 days after inclusion day

Amylase culture in bronchoalveolar fluid is compared to gold standard culture

次要结局

未报告次要终点

研究者

发起方
University Hospital, Bordeaux
申办方类型
Other
责任方
Sponsor

研究点 (1)

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