Vanderbilt Clinical Trials

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

Purpose

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

Condition

Ventilator Associated Pneumonia (VAP)

Eligibility

Eligible Ages: Over 18 Years
Eligible Genders: All
Accepts Healthy Volunteers: No

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

Study Design

Phase: N/A
Study Type: Interventional
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Primary Purpose: Diagnostic
Masking: None (Open Label)

Arm Groups

Arm	Description	Assigned Intervention
Experimental ventilated trauma patients with pneumonia	ventilated trauma patients with pneumonia	Procedure: molecular analysis of exhaled breath condensate Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate Procedure: molecular analysis of bronchoalveolar lavage (BAL) aspirate
Experimental ventilated trauma patients without pneumonia	ventilated trauma patients without pneumonia	Procedure: molecular analysis of exhaled breath condensate Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate
Experimental ventilated surgical ICU patients with pneumonia	ventilated surgical ICU patients with pneumonia	Procedure: molecular analysis of exhaled breath condensate Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate Procedure: molecular analysis of bronchoalveolar lavage (BAL) aspirate
Experimental ventilated surgical ICU patients without pneumonia	ventilated surgical ICU patients without pneumonia	Procedure: molecular analysis of exhaled breath condensate Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate

More Details

Status: Terminated
Sponsor: Vanderbilt University Medical Center

Study Contact

Detailed Description

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.