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

Not Applicable

Terminated

• Conditions: Ventilator Associated Pneumonia (VAP)
• Interventions: Procedure: molecular analysis of exhaled breath condensate; Procedure: molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate; Procedure: molecular analysis of bronchoalveolar lavage (BAL) aspirate

• Registration Number: NCT02652247
• Lead Sponsor: Vanderbilt University Medical Center

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.

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-01-07
• Study First Submitted QC: 2016-01-08
• Study First Posted: 2016-01-11
• Primary Completion: 2022-06
• Study Completion: 2022-06
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-01
• Last Update Posted: 2022-08-04

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 110

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ventilated surgical ICU patients with pneumonia	molecular analysis of exhaled breath condensate	ventilated surgical ICU patients with pneumonia
ventilated trauma patients without pneumonia	molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate	ventilated trauma patients without pneumonia
ventilated surgical ICU patients with pneumonia	molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate	ventilated surgical ICU patients with pneumonia
ventilated trauma patients with pneumonia	molecular analysis of exhaled breath condensate	ventilated trauma patients with pneumonia
ventilated surgical ICU patients without pneumonia	molecular analysis of exhaled breath condensate	ventilated surgical ICU patients without pneumonia
ventilated trauma patients with pneumonia	molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate	ventilated trauma patients with pneumonia
ventilated trauma patients with pneumonia	molecular analysis of bronchoalveolar lavage (BAL) aspirate	ventilated trauma patients with pneumonia
ventilated trauma patients without pneumonia	molecular analysis of exhaled breath condensate	ventilated trauma patients without pneumonia
ventilated surgical ICU patients without pneumonia	molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate	ventilated surgical ICU patients without pneumonia
ventilated surgical ICU patients with pneumonia	molecular analysis of bronchoalveolar lavage (BAL) aspirate	ventilated surgical ICU patients with pneumonia

Primary Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States