Exhaled Breath: A Novel Technique for Rapid Diagnosis of Respiratory Diseases and Infections
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-120
SponsorOregon Health and Science University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Non-COVID-19 adult consented patients (>18yo) on ventilatory support in the ICU at OHSU
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
There is no intervention in this observational study
Other interventionNo 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.
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: non-COVID patients on ventilator support1 intervention
Trial outcomes
Primary outcomes
1
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)Secondary outcomes
1
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)Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov