Intubation Complication Clinical Trial
Official title:
Exploratory Analysis of Pulmonary Microbiome in Patients Intubated for Non-pulmonary Conditions- A Pilot Study
This prospective, multicentric study investigates the modifications of pulmonary microbiome that occur in patients who need mechanical ventilation for non-pulmonary conditions. Genomic analysis will be performed by 16S RNA amplification on biological samples (bronchial aspirate) collected from patients.
The microbiome is defined as a community of microorganisms (such as bacteria, fungi, and
viruses) that inhabit a particular organ. This prospective, multicentric, observational study
investigates the bacterial changes that occur in the pulmonary microbiome during the first 72
hours of mechanical ventilation in patients who have been intubated for non-pulmonary
conditions in intensive care units (ICU).
To this aim, genetic analyses will be performed on bronchial aspirate samples that will be
collected from patients during their staying in ICU. Demographic and clinical information
will be retrieved from patients' clinical reports and recorded in an apposite clinical report
forms (CRF) in anonymized way. In particular, the reason for the admission to ICU, absence fo
concomitant pulmonary diseases, comorbidities, body mass index, hematological examination
results, concomitant therapies, antibiotic therapy performed in the 30 days prior to the
admission, ventilation associated pneumonia (VAP)-preventing procedures, complications during
mechanical ventilation, length of mechanical ventilation will be recorded in the CRF.
The study will last 24 months.
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