Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Patients at Increased Risk for the Development of Ventilator-associated Pneumonia in the Intensive Care Unit

Study Overview
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Brief Summary
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Ventilator-associated pneumonia (VAP) remains the most frequent healthcare-associated infection (HAI) in the intensive care unit (ICU) and one of the most critical risk factors associated with both significant morbidity as well as mortality. Although VAP treatment relies on early and appropriate antimicrobial therapy, several preventive measures have been described in the literature in order to limit its incidence and clinical impact in the ICU. Among these, preventing biofilm formation on the inner surface of the endotracheal tube appears to hold promise. Yet there is a lack of clinical relevant data documenting a causal relation between biofilm formation and VAP. Designed to overcome this critical limitation, the BIOPAVIR study intends to provide a better structural and microbiological characterization of endotracheal tube biofilm in critically ill patients at increased risk for the development of VAP in ICU during COVID-19 pandemic.

Official Title
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Structural and Microbiological Characterization of Endotracheal Tube Biofilm in Patients at Increased Risk for the Development of Ventilator-associated Pneumonia in the Intensive Care Unit

Conditions
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Biofilm Formation, Structural and Microbiological Characterization of Endotracheal Tube Biofilm, Ventilator-associated Pneumonia (VAP)

Intervention / Treatment
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* Biological: microbiological characterization


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patient > 18 years of age with mechanical ventilation for >2 calendar days Exclusion Criteria: inability to collect or dispatch the endotracheal tube for proper characterization within 24 hours post-extubation

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BIOPAVIR Cohort<br>Critically ill patient > 18 years of age with mechanical ventilation for >2 calendar days, at increased risk for the development of Ventilator-Associated Pneumonia in the Intensive Care Unit during COVID-19 pandemic. | Biological: microbiological characterization<br>* microbiological characterization of endotracheal tube biofilm<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of Ventilator-associated pneumonia (VAP) | Provide a better understanding of the correlation between structural and microbiological characterization of endotracheal tube biofilm in critically ill patients and increased risk for the development of VAP in ICU during COVID-19 pandemic. | Immediately after extubation of the patient | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Development of other VAP, healthcare-associated infection (HAI) or mortality | Provide a better understanding of the correlation between structural and microbiological characterization of endotracheal tube biofilm in critically ill patients and increased risk for the development of other VAP, healthcare-associated infection (HAI) or mortality in ICU during COVID-19 pandemic. | Immediately after extubation of the patient |