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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-11-30

Study Completion Date

2026-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Pulmonary Disease Critical Illness

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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non-COVID patients on ventilator support

There is only one arm in the study, no randomization. Any non-COVID patient admitted to the ICU and requiring ventilation support will be eligible for enrollment into the study.

There is no intervention in this observational study

Intervention Type OTHER

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.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

120 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No