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临床试验/NCT04911244
NCT04911244已完成不适用

Assessment of Different Diagnostic Modalities for Detection of Ventilator Associated Pneumonia

Assiut University0 个研究点目标入组 100 人开始时间: 2016年8月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
主要终点
To detected diagnostic accuracy of chest ultrasound in VAP.

研究概览

简要总结

asses diagnostic performance of different methods for detection of ventilator associated pneumonia.

详细描述

Ventilator associated pneumonia (VAP) is a common cause of nosocomial infection, that can complicate mechanical ventilation and is related to significant utilization of health-care resources.

The diagnosis of VAP is subjected to considerable interobserver variability. The Centers for Disease Control and Prevention (CDC) definition of VAP uses a combination of clinical, radiographic, and micro-biological criteria for diagnosis, but in the absence of a definite diagnostic test, the accurate diagnosis and treatment of VAP is limited.

The clinical pulmonary infection score (CPIS) was developed to objectively diagnose VAP and assign points on the basis of clinical and radiographic data, but its role in diagnosing pneumonia remains controversial .

Lung ultrasound (LUS) is a simple, non irradiating, noninvasive, cost-effective, bedside technique. It has been successfully applied for monitoring aeration and monitoring antibiotic efficacy in ventilator-associated pneumonia (VAP). However, no scientific evidence is yet available on whether LUS reliably improves the diagnosis of VAP.

Quantitative bacterial cultures of the specimen obtained from the lower airways using bronchoscope were proposed for VAP diagnosis with a cut off value of 104 colony-forming unit/ml. However, microbiological cultures cannot guide the early clinical management of patients with a suspected VAP, as they need at least 24 hours for preliminary results. So, starting antibiotics remains a challenge. Moreover, bronchoscopy is not always easy to perform in hypoxemic patients and not promptly available in all ICUs. Therefore, it can be replaced by tracheal aspirate microbiological samples.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Single Group
主要目的
Diagnostic

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

  • All adult patients mechanically ventilated for at least 48 hours in Respiratory ICU were included in the study.
  • Clinically suspected VAP according to simplified Clinical Pulmonary Infectious Score exceeding
  • Or new or extension of a radiological image with at least two of the following clinical criteria:
  • Body temperature ≥ 38.5 ° C or <36 ° C.
  • Leukocytes> 10 * 103 / ml or <4 * 103/ ml or > 10% immature cells (in the absence of other known causes).
  • Purulent tracheal secretions.
  • Hypoxemia with PaO2 <60 mmHg or a PaO2 / FiO2 <300.

排除标准

  • Patients with diagnosis of community acquired pneumonia or hospital acquired pneumonia before starting of mechanical ventilation.
  • Patients who are contraindicated for bronchoscopy

结局指标

主要结局

To detected diagnostic accuracy of chest ultrasound in VAP.

时间窗: 3 years

To identify sensitivity and specificity of chest ultrasound in VAP diagnosis

To detected diagnostic accuracy of protected endotracheal aspirate in VAP.

时间窗: 3 years

To identify sensitivity and specificity of protected endotracheal aspirate in VAP diagnosis

To detected diagnostic accuracy of usual endotracheal aspirate in VAP.

时间窗: 3 years

To identify sensitivity and specificity of usual endotracheal aspirate in VAP diagnosis

To detected diagnostic accuracy of chest X-ray in VAP.

时间窗: 3 years

To identify sensitivity and specificity of chest X-ray in VAP diagnosis

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Sahar Refaat Mahmoud

Principle investigator

Assiut University

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Diagnostic Modalities for VAP Detection | 临床试验