Actively Recruiting
Exhaled Breath: A Novel Technique for Rapid Diagnosis of Respiratory Diseases and Infections
Led by Oregon Health and Science University · Updated on 2025-01-14
100
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating a new method using advanced mass spectrometry techniques, Orbitrap and Matrix-Assisted Laser Desorption Ionization (MALDI), to analyze exhaled breath in non-COVID patients admitted to the ICU who require ventilator support. The study aims to rapidly and accurately detect pulmonary diseases and inflammatory markers early, especially ventilator-associated pneumonia, by examining proteins and biomarkers in breath samples. This observational study focuses on critically ill, mechanically ventilated patients to validate this novel diagnostic approach. The study involves collecting exhaled breath samples directly from ventilator tubing, capturing 5-15% of the breath without altering standard medical care. These samples will be analyzed for proteins and peptides that may indicate respiratory infections or inflammation. The collected data will be compared with hospital clinical records obtained near the time of sample collection to correlate breath analysis results with existing diagnostic information. There is only one study group, including any eligible non-COVID ICU patient on ventilator support. Participants will be monitored from admission until discharge, up to 30 days, during which researchers will evaluate the breath-based diagnostic platform for early detection of ventilator-associated pneumonia and assess the effects of antibiotic treatment over time. No direct interventions are made beyond breath sample collection. The study includes clinical data correlation and continuous safety monitoring, with participant involvement limited to the observational collection of breath samples and related hospital data throughout their ICU stay.
CONDITIONS
Brief Title
Exhaled Breath: A Novel Technique for Rapid Diagnosis of Respiratory Diseases and Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Non-COVID-19 adult patients over 18 years old
- Currently on ventilatory support in the ICU at Oregon Health and Science University
- Able and willing to provide consent for participation
You will not qualify if you...
- Patients with severe respiratory distress defined by arterial pO2 less than 60 mmHg despite maximal oxygen and ventilator settings
- Patients with severe hemodynamic instability receiving two or more intravenous pressors or inotropic medications and having mean arterial pressure below 60 mmHg or systolic blood pressure below 80 mmHg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - Admission to discharge (up to 30 days)
Participants who require ventilator support in the ICU have their exhaled breath collected and analyzed using mass spectrometry without affecting their standard medical care.
Samples collected during hospitalization as clinically indicated
Trial Site Locations
Total: 1 location
1
Oregon Health and Science University
Portland, Oregon, United States, 97239
Actively Recruiting
Research Team
L
Laura H Nguyen, B.S.
A
Albert Chi, M.D., F.A.C.S
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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