Exploratory Analysis of Pulmonary Microbiome in Intubated Patients

Completed

• Conditions: Intubation Complication

• Registration Number: NCT03720093
• Lead Sponsor: University of Milano Bicocca

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.

Study Timeline

• Study Start: 2017-10-08
• Study First Submitted: 2018-10-09
• Study First Submitted QC: 2018-10-23
• Study First Posted: 2018-10-25
• Primary Completion: 2019-11-20
• Study Completion: 2020-01-24
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-01
• Last Update Posted: 2020-07-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.	At the time of intubation and after 72 hours from intubation	Two samples of bronchial aspirate were collected (one at the time of incubation and one 72 hours post-intubation) and analyzed by Polymerase Chain Reaction (PCR) by amplifying 16 Svedberg (16S) ribosomal RNA. Primers that specifically recognize hypervariable regions of 16S sub-unit will be used. At 5' end an adaptor will be inserted to prepare the MiSeqsequencing library. The classification of microbiome taxa will be expressed as diversity measure (diversity index alpha or beta); the frequency of the most represented taxa and the confidence interval will be calculated. Differences in microbiome composition will be represented with the analysis of principal coordinates (PCoA) based on phylogenetic distance (matrix UNIFRAC).

Trial Locations

Locations (3)

Ospedale di Parma; 🇮🇹 Parma, Italy

ASST-Monza; 🇮🇹 Monza, MB, Italy

Ospedale Niguarda; 🇮🇹 Milano, Italy