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

Ventilator Associated Pneumonia (VAP) Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02652247
• Other study ID #: 151194
• Secondary ID: 1R01GM115353-01
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: June 2022

Study information

• Verified date: August 2022
• Source: Vanderbilt University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 110
• Est. completion date: June 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia (VAP)

Intervention

Procedure:
• molecular analysis of exhaled breath condensate

• molecular analysis of mini-bronchoalveolar lavage (BAL) aspirate

• molecular analysis of bronchoalveolar lavage (BAL) aspirate

Locations

Country	Name	City	State
United States	Vanderbilt University Medical Center	Nashville	Tennessee

Sponsors (2)

Lead Sponsor	Collaborator
Vanderbilt University Medical Center	National Institute of General Medical Sciences (NIGMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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