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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2022-06-30

Brief Summary

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

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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.

Conditions

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Ventilator Associated Pneumonia (VAP)

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

Intervention Type PROCEDURE

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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No