Prospective Observational Study of Exhaled Carbon MonoxideTrajectories and Outcomes in ICU Patients (NCT07454057) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Prospective Observational Study of Exhaled Carbon MonoxideTrajectories and Outcomes in ICU Patients
220 participantsStarted 2026-03-15
Plain-language summary
This is a single-center, prospective, observational study in adult intensive care unit (ICU) patients. The study will measure exhaled carbon monoxide (eCO) once daily for up to 7 days after ICU admission using a red blood cell lifespan breath analyzer, which simultaneously estimates erythrocyte lifespan. eCO is a gas produced endogenously during heme degradation and may reflect hemolysis, oxidative stress, and inflammation in critically ill patients.
The purpose of this study is to describe how eCO changes over time in ICU patients and to determine whether different eCO patterns are associated with clinical outcomes. The primary outcome is all-cause mortality within 28 days after enrollment. Secondary outcomes include 90-day mortality, acute kidney injury, organ dysfunction assessed by SOFA score, transfusion requirement, changes in anemia-related indices, ICU length of stay, and duration of invasive mechanical ventilation. Participation does not change routine clinical care; study procedures involve breath sampling and collection of clinical data from the medical record.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age ≥ 18 years
✓. Admitted to the intensive care unit (ICU) at the study site
✓. Expected ICU length of stay ≥ 48 hours
✓. Able to complete exhaled carbon monoxide (eCO) measurement (spontaneously breathing or mechanically ventilated)
✓. Written informed consent provided by the patient or a legally authorized representative
Exclusion criteria
✕. Carbon monoxide poisoning
✕. Active smoking within 24 hours prior to ICU admission
✕. Unable to perform breath sampling (e.g., massive airway bleeding, severe airway obstruction, extracorporeal membrane oxygenation)
✕. Ineffective sampling due to poor mask seal or special ventilation modes