Purpose

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

Condition

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

ArmDescriptionAssigned 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

Recruiting Locations

Vanderbilt University Medical Center
Nashville, Tennessee 37232

More Details

Status
Recruiting
Sponsor
Vanderbilt University Medical Center

Study Contact

Addison K May, MD
615-936-0189

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.