Recruiting

Observational Study

Sponsor:

Oregon Health and Science University

Code:

NCT06775106

Conditions

Pulmonary Disease

Critical Illness

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

There is no intervention in this observational study

Study Details

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

Study ID

NCT06775106

Start date

Nov 30, 2024

Status verified date

Jan, 2025

Completion date

Dec 31, 2026

Anticipated

Primary completion date

Dec 31, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

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.

Interventions

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.

Primary outcome measure

  • 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) ]

Central Contacts and Locations

Central contacts

Laura H Nguyen, B.S.

503-418-4733nguyelau@ohsu.edu

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

503-494-5300chia@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Laura Nguyen, BS

503-418-4733traumare@ohsu.edu

Principal Investigator:

Albert Chi, MD

More Information

Sponsor

Oregon Health and Science University

Last update posted

Jan 14, 2025

Last verified

Jan, 2025

Keywords

  • ventillator
  • critical care
  • pulmonary disease
  • inflammatory biomarkers

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2025-01-14.