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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02652247

Enrollment

110

Registered

2016-01-11

Start date

2016-01-31

Completion date

2022-06-30

Last updated

2022-08-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ventilator Associated Pneumonia (VAP)

Keywords

trauma, ventilator, surgical ICU

Brief summary

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

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.

Interventions

PROCEDUREmolecular analysis of exhaled breath condensate

PROCEDUREmolecular analysis of mini-bronchoalveolar lavage (BAL) aspirate

PROCEDUREmolecular analysis of bronchoalveolar lavage (BAL) aspirate

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
The number of patients with a positive association between the exhaled breath condensate fluid and BAL fluid in in patients suspected of pneumonia.	enrollment to hospital day 15	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.
The per cent of positive correlation for the development & resolution of pneumonia based on changes in bacteria found in the exhaled breath condensate.	enrollment to hospital day 15	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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026