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TerminatedNCT02652247Updated Aug 4, 2022

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

An interventional study of molecular analysis of exhaled breath condensate and molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate in Ventilator Associated Pneumonia (VAP), sponsored by Vanderbilt University Medical Center. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-08-04.

Sponsored by Vanderbilt University Medical Center · Not applicable, Interventional, and Diagnostic

Why this study was terminated
We did not have the funding to complete the study enrollment.
Phase
Not applicable
Study type
Interventional
Enrollment
110
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study summary

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

Read the 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.

02

Conditions studied

  • Ventilator Associated Pneumonia (VAP)

Keywords

  • trauma
  • ventilator
  • surgical ICU
03

In context

Pneumonia, Ventilator-Associated

392 studies on the registry are indexed under Pneumonia, Ventilator-Associated; 81 are open to participants now.

This study's enrollment of 110 is close to the median of 122 across 254 interventional studies indexed under Pneumonia, Ventilator-Associated.

Browse Pneumonia, Ventilator-Associated studies →

Lead sponsor

Vanderbilt University Medical Center is the lead sponsor of 824 studies on the registry; 164 are open to participants now.

Of its 122 completed or terminated interventional studies of FDA-regulated products, 91 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Non-randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
110 participants (actual)

Study arms

  • 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

Interventions

  • Proceduremolecular analysis of exhaled breath condensate
  • Proceduremolecular analysis of mini-bronchoalveolar lavage (BAL) aspirate
  • Proceduremolecular analysis of bronchoalveolar lavage (BAL) aspirate
06

What researchers measure

Primary outcomes

  1. The number of patients with a positive association between the exhaled breath condensate fluid and BAL fluid in in patients suspected of pneumonia.

    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.

    Time frame: enrollment to hospital day 15

  2. The per cent of positive correlation for the development & resolution of pneumonia based on changes in bacteria found in the exhaled breath condensate.

    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.

    Time frame: enrollment to hospital day 15

07

Study locations

1 site
  • Vanderbilt University Medical Center
    Nashville, Tennessee 37232, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 4, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02652247
Lead sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of General Medical Sciences (NIGMS)
Responsible party
Wonder Drake (Professor, Vanderbilt University Medical Center) — Principal investigator
First posted
Jan 11, 2016
Start date
Jan 2016
Primary completion
Jun 2022
Completion
Jun 2022
Last update
Aug 4, 2022

Study contacts

Addison K May, MD
principal investigator · Vanderbilt University Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is terminated, as verified in Aug 2022. You cannot join it, but the record below documents what was studied.

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