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Diagnostic Modalities for VAP Detection

2021年5月30日 更新者:Sahar Refaat Mahmoud、Assiut University

Assessment of Different Diagnostic Modalities for Detection of Ventilator Associated Pneumonia

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

研究概览

详细说明

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.

研究类型

介入性

注册 (实际的)

100

阶段

  • 不适用

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 及以上 (成人、年长者)

接受健康志愿者

有资格学习的性别

全部

描述

Inclusion Criteria:

  • All adult patients mechanically ventilated for at least 48 hours in Respiratory ICU were included in the study.

who had:

  • Clinically suspected VAP according to simplified Clinical Pulmonary Infectious Score exceeding 6.
  • 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.

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:诊断
  • 分配:非随机化
  • 介入模型:单组作业

武器和干预

参与者组/臂
干预/治疗
实验性的:VAP group
patients confirmed diagnosis of VAP with bronchoalveolar lavage
endobronchial sampling through bronchoscopy
其他名称:
  • protected endotracheal aspirate
实验性的:Non VAP group
patients confirmed not VAP with bronchoalveolar lavage
endobronchial sampling through bronchoscopy
其他名称:
  • protected endotracheal aspirate

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
To detected diagnostic accuracy of chest ultrasound in VAP.
大体时间:3 years
To identify sensitivity and specificity of chest ultrasound in VAP diagnosis
3 years
To detected diagnostic accuracy of protected endotracheal aspirate in VAP.
大体时间:3 years
To identify sensitivity and specificity of protected endotracheal aspirate in VAP diagnosis
3 years
To detected diagnostic accuracy of usual endotracheal aspirate in VAP.
大体时间:3 years
To identify sensitivity and specificity of usual endotracheal aspirate in VAP diagnosis
3 years
To detected diagnostic accuracy of chest X-ray in VAP.
大体时间:3 years
To identify sensitivity and specificity of chest X-ray in VAP diagnosis
3 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2016年8月1日

初级完成 (实际的)

2019年10月1日

研究完成 (实际的)

2020年2月1日

研究注册日期

首次提交

2021年5月24日

首先提交符合 QC 标准的

2021年5月30日

首次发布 (实际的)

2021年6月2日

研究记录更新

最后更新发布 (实际的)

2021年6月2日

上次提交的符合 QC 标准的更新

2021年5月30日

最后验证

2021年5月1日

更多信息

与本研究相关的术语

药物和器械信息、研究文件

研究美国 FDA 监管的药品

研究美国 FDA 监管的设备产品

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