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OpenTrials
Completed

NCT Number: NCT04911244

Diagnostic Modalities for VAP Detection

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

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Key information

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

bronchoalveolar lavage

Diagnostic Test

endobronchial sampling through bronchoscopy

Other names: protected endotracheal aspirate

Primary outcomes

  1. To detected diagnostic accuracy of chest ultrasound in VAP.

    Time frame: 3 years

    To identify sensitivity and specificity of chest ultrasound in VAP diagnosis

  2. To detected diagnostic accuracy of protected endotracheal aspirate in VAP.

    Time frame: 3 years

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

  3. To detected diagnostic accuracy of usual endotracheal aspirate in VAP.

    Time frame: 3 years

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

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

    Time frame: 3 years

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

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

Assessment of Different Diagnostic Modalities for Detection of Ventilator Associated Pneumonia

Important dates

Study start
2016
Primary completion
2019
Study completion
2020
First posted
Jun 2, 2021
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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