Back to resultsSerial, Non-invasive Analysis of Exhaled Breath Condensate in Ventilated Trauma Patients
Primary Purpose
Ventilator Associated Pneumonia (VAP)
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
molecular analysis of exhaled breath condensate
molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate
molecular analysis of bronchoalveolar lavage (BAL) aspirate
Sponsored by
About this trial
This is an interventional diagnostic trial for Ventilator Associated Pneumonia (VAP) focused on measuring trauma, ventilator, surgical ICU
Eligibility Criteria
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
Sites / Locations
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Experimental
Experimental
Experimental
Experimental
Arm Label
ventilated trauma patients with pneumonia
ventilated trauma patients without pneumonia
ventilated surgical ICU patients with pneumonia
ventilated surgical ICU patients without pneumonia
Arm Description
ventilated trauma patients with pneumonia
ventilated trauma patients without pneumonia
ventilated surgical ICU patients with pneumonia
ventilated surgical ICU patients without pneumonia
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02652247
First Posted
January 7, 2016
Last Updated
August 1, 2022
Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of General Medical Sciences (NIGMS)
1. Study Identification
Unique Protocol Identification Number
NCT02652247
Brief Title
Serial, Non-invasive Analysis of Exhaled Breath Condensate in Ventilated Trauma Patients
Official Title
Serial, Non-invasive Molecular Analysis of Exhaled Breath Condensate to Define the Pulmonary Flora in Critically Injured, Ventilated Adults: The Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
August 2022
Overall Recruitment Status
Terminated
Why Stopped
We did not have the funding to complete the study enrollment.
Study Start Date
January 2016 (undefined)
Primary Completion Date
June 2022 (Actual)
Study Completion Date
June 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Vanderbilt University Medical Center
Collaborators
National Institute of General Medical Sciences (NIGMS)
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ventilator Associated Pneumonia (VAP)
Keywords
trauma, ventilator, surgical ICU
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
110 (Actual)
8. Arms, Groups, and Interventions
Arm Title
ventilated trauma patients with pneumonia
Arm Type
Experimental
Arm Description
ventilated trauma patients with pneumonia
Arm Title
ventilated trauma patients without pneumonia
Arm Type
Experimental
Arm Description
ventilated trauma patients without pneumonia
Arm Title
ventilated surgical ICU patients with pneumonia
Arm Type
Experimental
Arm Description
ventilated surgical ICU patients with pneumonia
Arm Title
ventilated surgical ICU patients without pneumonia
Arm Type
Experimental
Arm Description
ventilated surgical ICU patients without pneumonia
Intervention Type
Procedure
Intervention Name(s)
molecular analysis of exhaled breath condensate
Intervention Type
Procedure
Intervention Name(s)
molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate
Intervention Type
Procedure
Intervention Name(s)
molecular analysis of bronchoalveolar lavage (BAL) aspirate
Primary Outcome Measure Information:
Title
The number of patients with a positive association between the exhaled breath condensate fluid and BAL fluid in in patients suspected of pneumonia.
Description
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
Title
The per cent of positive correlation for the development & resolution of pneumonia based on changes in bacteria found in the exhaled breath condensate.
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Addison K May, MD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Serial, Non-invasive Analysis of Exhaled Breath Condensate in Ventilated Trauma Patients
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