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

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

Study Overview

• Status: Terminated
• Conditions: Ventilator Associated Pneumonia (VAP)
• Intervention / Treatment: Procedure: molecular analysis of exhaled breath condensate; Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate; Procedure: molecular analysis of bronchoalveolar lavage (BAL) aspirate

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.

• Study Type: Interventional
• Enrollment (Actual): 110
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	Procedure: molecular analysis of exhaled breath condensate; Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate
Experimental: 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	Procedure: molecular analysis of exhaled breath condensate; Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	enrollment to hospital day 15
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.	enrollment to hospital day 15

Collaborators and Investigators

• Sponsor: Vanderbilt University Medical Center
• Collaborators: National Institute of General Medical Sciences (NIGMS)
• Investigators: Principal Investigator: Addison K May, MD, Vanderbilt University Medical Center

Study record dates

Study Major Dates

• Study Start: January 1, 2016
• Primary Completion (Actual): June 1, 2022
• Study Completion (Actual): June 1, 2022

Study Registration Dates

• First Submitted: January 7, 2016
• First Submitted That Met QC Criteria: January 8, 2016
• First Posted (Estimate): January 11, 2016

Study Record Updates

• Last Update Posted (Actual): August 4, 2022
• Last Update Submitted That Met QC Criteria: August 1, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: trauma; ventilator; surgical ICU
• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia; Lung Diseases; Disease Attributes; Cross Infection; Iatrogenic Disease; Healthcare-Associated Pneumonia; Pneumonia, Ventilator-Associated; Molecular Mechanisms of Pharmacological Action; Chelating Agents; Sequestering Agents; Dimercaprol
• Other Study ID Numbers: 151194; 1R01GM115353-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No