An observational study in Pulmonary Disease and Critical Illness, sponsored by Oregon Health and Science University. Recruiting at 1 site in United States. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2025-01-14.
Sponsored by Oregon Health and Science University · Observational
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.
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.
3,303 studies on the registry are indexed under Lung Diseases; 355 are open to participants now.
This study's planned enrollment of 100 is below the median of 157 across 929 observational studies indexed under Lung Diseases.
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Of its 49 completed or terminated interventional studies of FDA-regulated products, 36 (73%) have results posted.
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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.
Exclusion Criteria:
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.
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.
Exhaled breath-based diagnostic platform for detecting ventilator-associated pneumonia (VAP) early in critically ill, mechanically ventilated patients.
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.
Time frame: Admission to discharge (up to 30 days)
Evaluate the effects of antibiotic treatment over time
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.
Time frame: Admission to discharge (up to 30 days)
Plan to share: Yes — De-identified study data will be shared with other researchers who are interested in any secondary analysis of the study.
Supporting information: Study protocol, Sap
No publications or documents are linked to this record.
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Oregon Health and Science University