Exhaled Breath: A Novel Technique for Rapid Diagnosis of Respiratory Diseases and Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: There is no intervention in this observational study.
- Who it may be relevant to
- Registry conditions: Pulmonary Disease, Critical Illness. Basic parameters: 18 years — 120 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Other There is no intervention in this observational study
No direct intervention will be done to patients eligible for the study. There will be a shunt placed to divert 5-15% of exhaled breath into a collection tube. This will not affect the patient's existing standard medical care.
Primary outcome measures
- Exhaled breath-based diagnostic platform for detecting ventilator-associated pneumonia (VAP) early in critically ill, mechanically ventilated patients. [Time frame: Admission to discharge (up to 30 days)]
Secondary outcome measures (1)
- Evaluate the effects of antibiotic treatment over time [Time frame: Admission to discharge (up to 30 days)]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
United States · 1 center
- Oregon Health and Science University — Portland
Identifiers
NCT: NCT06775106 · 27461