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

Vanderbilt University Medical Center

Status: Terminated

Conditions: Ventilator Associated Pneumonia (VAP)

Treatments: Procedure: molecular analysis of bronchoalveolar lavage (BAL) aspirate; Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate; Procedure: molecular analysis of exhaled breath condensate

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02652247

151194

1R01GM115353-01 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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

Full 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.

Enrollment: 110 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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110 participants in 4 patient groups

ventilated trauma patients with pneumonia

Experimental group

Description:

ventilated trauma patients with pneumonia

Treatment:

Procedure: molecular analysis of exhaled breath condensate

Procedure: molecular analysis of bronchoalveolar lavage (BAL) aspirate

Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate

ventilated trauma patients without pneumonia

Experimental group

Description:

ventilated trauma patients without pneumonia

Treatment:

Procedure: molecular analysis of exhaled breath condensate

Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate

ventilated surgical ICU patients with pneumonia

Experimental group

Description:

ventilated surgical ICU patients with pneumonia

Treatment:

Procedure: molecular analysis of exhaled breath condensate

Procedure: molecular analysis of bronchoalveolar lavage (BAL) aspirate

Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate

ventilated surgical ICU patients without pneumonia

Experimental group

Description:

ventilated surgical ICU patients without pneumonia

Treatment:

Procedure: molecular analysis of exhaled breath condensate

Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate