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Diagnostic Modalities for VAP Detection

Assessment of Different Diagnostic Modalities for Detection of Ventilator Associated Pneumonia

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04911244
Enrollment
100
Registered
2021-06-02
Start date
2016-08-31
Completion date
2020-02-29
Last updated
2021-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia

Brief summary

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

Detailed description

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.

Interventions

DIAGNOSTIC_TESTbronchoalveolar lavage

endobronchial sampling through bronchoscopy

Sponsors

Assiut University
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
To detected diagnostic accuracy of chest ultrasound in VAP.3 yearsTo identify sensitivity and specificity of chest ultrasound in VAP diagnosis
To detected diagnostic accuracy of protected endotracheal aspirate in VAP.3 yearsTo identify sensitivity and specificity of protected endotracheal aspirate in VAP diagnosis
To detected diagnostic accuracy of usual endotracheal aspirate in VAP.3 yearsTo identify sensitivity and specificity of usual endotracheal aspirate in VAP diagnosis
To detected diagnostic accuracy of chest X-ray in VAP.3 yearsTo identify sensitivity and specificity of chest X-ray in VAP diagnosis

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026