Exhaled Breath: A Novel Technique for Rapid Diagnosis of Respiratory Diseases and Infections

Recruiting

• Conditions: Pulmonary Disease; Critical Illness

• Registration Number: NCT06775106
• Lead Sponsor: Oregon Health and Science University

Brief Summary

This study aims to use mass spectrometry techniques to analyze exhaled patient breath in non-COVID ICU-admitted patients requiring ventilation for a rapid and accurate early detection of pulmonary diseases and inflammatory markers.

Detailed Description

The major aim of this observational study is to validate the new technique, Orbitrap and Matrix-Assisted Laser Desorption Ionization (MALDI) mass spectrometry, to sample and analyze exhaled patient breath that may be then used in non-intensive care unit (ICU) environments where rapid virus or other respiratory pathogen detection is of great utility. The ICU permits the direct measure of ventilator-dependent patients with known pulmonary disease (by sputum, chest x-ray, and/or bronchial lavage analysis) together with a simple, pure, and concentrated breath sample (expired air via ventilator tubing) for analysis.

Sub-aim 1: Run patient samples on Orbitrap \& MALDI. Proteins in the samples will be captured and analyzed by Orbitrap and MALDI mass spectrometry. Selected proteins will be enzymatically digested into peptides and correlations to existing peptides from previous proteomic studies of exhaled breath condensates (EBC) will be examined. Candidate virus \& bacterial proteins, as well as other cellular and biomarkers, will be cataloged.

Sub-aim 2: Correlate collected analyzed sample collection during hospitalization with other hospital data that may have been collected for clinical reasons by the clinical care team, at or around the study time period (+/- 3 days), concerning for the laboratory diagnosis of respiratory disease.

Study Timeline

• Study First Submitted: 2024-08-27
• Study Start: 2024-11-30
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-09
• Last Update Submitted: 2025-01-09
• Study First Posted: 2025-01-14
• Last Update Posted: 2025-01-14
• Primary Completion: 2026-12-31
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Non-COVID-19 adult consented patients (>18yo) on ventilatory support in the ICU at OHSU

Exclusion Criteria

• Patients with "severe respiratory distress" as defined by arterial pO2 of <60 mmHg on maximal FiO2 & optimal ventilator settings
• Patient with severe hemodynamic instability as defined by (a) receiving IV infusion of 2 or more pressors or inotropic medications (Levophed, vasopressin, phenylephrine, or epinephrine) & (b) MAP of <60 mmHg or SB <80 mmHg

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Exhaled breath-based diagnostic platform for detecting ventilator-associated pneumonia (VAP) early in critically ill, mechanically ventilated patients.	Admission to discharge (up to 30 days)	This platform leverages advanced breath sampling technology and a host-response-based assay to detect specific elevated neutrophil proteases during bacterial infections like VAP. The noninvasive approach provides a safer and more efficient alternative to methods like bronchoalveolar lavage (BAL). This approach can differentiate between bacterial colonization and active infection by capturing and analyzing exhaled breath, allowing clinicians to initiate more timely and targeted therapies, thereby improving patient outcomes and reducing the misuse of antibiotics.

Secondary Outcome Measures

Name	Time	Method
Evaluate the effects of antibiotic treatment over time	Admission to discharge (up to 30 days)	By tracking the levels of specific host-response markers in exhaled breath, the approach can monitor the progression or resolution of infection in real time. This data will provide critical insights into whether antibiotic therapy is effectively reducing the infection or if adjustments to the treatment regimen are needed. This will help reduce the overuse of antibiotics, support the fight against antimicrobial resistance, and improve patient outcomes in ICUs.

Trial Locations

Locations (1)

Oregon Health and Science University; 🇺🇸 Portland, Oregon, United States