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

Study Overview
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Brief Summary
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To determine if the analysis of exhaled breath condensate correlates with the development & resolution of pneumonia.

Detailed Description
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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.

Official Title
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Serial, Non-invasive Molecular Analysis of Exhaled Breath Condensate to Define the Pulmonary Flora in Critically Injured, Ventilated Adults: The Clinical Trial

Conditions
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Ventilator Associated Pneumonia (VAP)

Intervention / Treatment
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* Procedure: molecular analysis of exhaled breath condensate
* Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate
* Procedure: molecular analysis of bronchoalveolar lavage (BAL) aspirate


Participation Criteria
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Eligibility Criteria
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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

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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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ventilated trauma patients with pneumonia<br>ventilated trauma patients with pneumonia | Procedure: molecular analysis of exhaled breath condensate<br> <br> Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate<br> <br> Procedure: molecular analysis of bronchoalveolar lavage (BAL) aspirate<br> <br> |
| Experimental: ventilated trauma patients without pneumonia<br>ventilated trauma patients without pneumonia | Procedure: molecular analysis of exhaled breath condensate<br> <br> Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate<br> <br> |
| Experimental: ventilated surgical ICU patients with pneumonia<br>ventilated surgical ICU patients with pneumonia | Procedure: molecular analysis of exhaled breath condensate<br> <br> Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate<br> <br> Procedure: molecular analysis of bronchoalveolar lavage (BAL) aspirate<br> <br> |
| Experimental: ventilated surgical ICU patients without pneumonia<br>ventilated surgical ICU patients without pneumonia | Procedure: molecular analysis of exhaled breath condensate<br> <br> Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | enrollment to hospital day 15 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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trauma, ventilator, surgical ICU