Clinical trial NCT06775106: Exhaled Breath: A Novel Technique for Rapid Diagnosis of Respiratory Diseases and Infections
Official title: Exhaled Breath: A Novel Technique for Rapid Diagnosis of Respiratory Diseases and Infections
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Pulmonary Disease
Critical Illness
Keywords: ventillator
critical care
pulmonary disease
inflammatory biomarkers
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2025-01-14
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 120
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Decisionally impaired adults will be included as part of the trauma population. The study aims to enroll patients who require ventilation support therefore qualifying some patients as decisionally impaired. Prisoners and pregnant women are excluded. Individuals under the age of 18 will not be included in the study.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Exhaled breath-based diagnostic platform for detecting ventilator-associated pneumonia (VAP) early in critically ill, mechanically ventilated patients.
timeFrame: Admission to discharge (up to 30 days)
Secondary outcomes:
measure: Evaluate the effects of antibiotic treatment over time
timeFrame: Admission to discharge (up to 30 days)
Other outcomes:
Locations:
city: Portland
country: United States
facility: Oregon Health and Science University
state: Oregon
Study officials:
References: