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NCT Number: NCT06775106

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

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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Key information

Age range

18 year–120 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Oregon Health and Science University

Portland, Oregon, 97239, United States

Location status: Recruiting

Location contact

Albert Chi, MD

PRINCIPAL_INVESTIGATOR

Laura Nguyen, BS

CONTACT

[email protected]

503-418-4733

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

There is no intervention in this observational study

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.

Primary outcomes

  1. 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)

    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 outcomes

  1. Evaluate the effects of antibiotic treatment over time

    Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Albert Chi, M.D., F.A.C.S

CONTACT

[email protected]

503-494-5300

Laura H Nguyen, B.S.

CONTACT

[email protected]

503-418-4733

Sponsors and collaborators

Lead sponsor

Oregon Health and Science University

Other

Registry information

Acronym: EXB

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jan 14, 2025
Registry last updated
Jan 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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