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

NCT06775106 | Recruiting

• 1 other identifier: 27461
• Study Type: observational
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Pulmonary Disease; Critical Illness

Keywords

ventillator; critical care; pulmonary disease; inflammatory biomarkers

Outcome Measures

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.

  Admission to discharge (up to 30 days)

Secondary Outcomes (1)

• Evaluate the effects of antibiotic treatment over time

  Admission to discharge (up to 30 days)

Study Arms (1)

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.

Other: There is no intervention in this observational study

Interventions

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.

non-COVID patients on ventilator support

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study 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.

You may qualify if:

• Non-COVID-19 adult consented patients (\>18yo) on ventilatory support in the ICU at OHSU

You may not qualify if:

• 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

Sponsors & Collaborators

• Oregon Health and Science University: lead

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

MeSH Terms

Conditions

Lung Diseases; Critical Illness

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Laura H Nguyen, B.S.

CONTACT

503-418-4733; nguyelau@ohsu.edu

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

CONTACT

503-494-5300; chia@ohsu.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D., F.A.C.S.

Study Record Dates

• First Submitted: August 27, 2024
• First Posted: January 14, 2025
• Study Start: November 30, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: January 14, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The study data will be available at the end of study enrollment and will only be available until primary study analysis is complete.

Locations

US (1)