Serial, Non-invasive Analysis of Exhaled Breath Condensate in Ventilated Trauma Patients

Vanderbilt University Medical Center110 enrolled

Overview

To determine if the analysis of exhaled breath condensate correlates with the development \& resolution of pneumonia.

This proposal investigates the utility of exhaled breath condensate fluid (EBCF) collected from heat moisture exchange (HME) filters connected to patient's endotracheal tubes for early, non-invasive detection of ventilator-associated pneumonia (VAP) in critically ill or injured ICU patients. The development of pneumonia during mechanical ventilation is the most common healthcare-associated infection in severely injured patients, accounting for substantial morbidity, excess ICU and hospital stay, additional cost and increased mortality.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

110

Conditions

Ventilator Associated Pneumonia (VAP)

Interventions

molecular analysis of exhaled breath condensatePROCEDURE

molecular analysis of mini-bronchoalveolar lavage (BAL) aspiratePROCEDURE

molecular analysis of bronchoalveolar lavage (BAL) aspiratePROCEDURE

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age 18 or older * Admitted to the Vanderbilt Trauma (TICU) and Surgical Intensive Care Units (SICU) * Mechanically ventilated for ≥2 successive days (without planned extubation within 24 hours of enrollment) Exclusion Criteria: * Less than 18 years of age * Expected survival less than 24 hours * Anticipated extubation within 24 hours of enrollment * Conditions limiting the subject's ability to tolerate collection of lavage specimens, including: FIO2 \> 80%; PEEP \> 16 cmH2O; Intracranial pressure \>20 cmH2O; Tracheal or mucosal bleeding; Platelet count \< 20,000 cells/uL; INR \> 2.0 * Known prisoners * Pneumonia diagnosis at the time of ICU admission

Locations (1)

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

The number of patients with a positive association between the exhaled breath condensate fluid and BAL fluid in in patients suspected of pneumonia.

To determine the association between the microbial community in both EBCF specimens and bronchoalveolar lavage fluid (BALF) samples in critically ill and injured, mechanically ventilated patients suspected of VAP.

Time frame: enrollment to hospital day 15

The per cent of positive correlation for the development & resolution of pneumonia based on changes in bacteria found in the exhaled breath condensate.

To develop a robust predictive model for the development of VAP and its resolution based on changes in the microbial community in EBCF collected over the course of ventilation.

Time frame: enrollment to hospital day 15

Data from ClinicalTrials.gov

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