Clinical trial NCT03720093: Exploratory Analysis of Pulmonary Microbiome in Intubated Patients
Official title: Exploratory Analysis of Pulmonary Microbiome in Patients Intubated for Non-pulmonary Conditions- A Pilot Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Intubation Complication
Keywords: ventilation
intubation
pulmonary microbiome
Lead sponsor: University of Milano Bicocca
Sponsor class: OTHER
Collaborators: name: Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
name: Niguarda Hospital
name: Parma University Hospital
First posted: 2018-10-25
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Intubated patients with mechanical ventilation for at least 48 hours

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

* patients undergo mechanical ventilation for non-pulmonary conditions (i.e. neurological condition)
* patients who are expected to need mechanical ventilation for \>48 hours

Exclusion Criteria:

* diagnosis at the ICU admission of pneumonia
* need of mechanical ventilation for pulmonary conditions.

Primary outcomes:
measure: Changes of pulmonary microbiome between the time of intubation and 72 hours post-intubation, through genetic analysis of bacterial 16 Svedberg (16S) ribosomal RNA in bronchial aspirate.
timeFrame: At the time of intubation and after 72 hours from intubation
Secondary outcomes:
Other outcomes:
Locations:
city: Monza
country: Italy
facility: ASST-Monza
state: MB
city: Milano
country: Italy
facility: Ospedale Niguarda
city: Parma
country: Italy
facility: Ospedale di Parma
Study officials:
affiliation: University of Milano Bicocca
name: Giuseppe Citerio, Professor
role: STUDY_DIRECTOR
affiliation: Fondazione Cà Granda, Policlinico Milano
name: Andrea Gori, Professor
role: STUDY_CHAIR
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