Acute respiratory distress syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: In order to be eligible to participate in this study, a subject must meet all of the following criteria: • Invasively ventilated. • Admitted to one of the participating ICUs. • Expected to receive invasive mechanical ventilation for at least 24 hours.
Exclusion criteria
Exclusion criteria: A potential subject who meets any of the following criteria will be excluded from participation in this study: • Expected to be deceased within 24 hours at the moment of inclusion. • Received invasive ventilation for more than 48 hours at any moment in the 7 days preceding the moment of inclusion. • Exhaled breath collection deemed inappropriate by the attending physicians. • Tracheostomy. • Active withdrawal from the study by the patient.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary independent variable Exhaled breath concentration of octane, measured by compact gas- chromatography. Primary dependent variable ARDS as defined by the Berlin definition. The variable ARDS will be defined in three ways, ARDS as defined by the clinician, ARDS as defined by the researcher and ARDS as defined by an expert panel. The expert panel will provide a label of uncertainty to their decision. Primary outcome Optimal sensitivity and specificity and cutoff for breath octane concentration in diagnosis of ARDS. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary independent variables • Volatile organic compounds in exhaled breath measured by gas- chromatography and mass-spectrometry. • Protein patterns (including but not limited to total protein, myeloperoxidase (MPO) and matrix metalloproteinase (MMP-9)) in fluid from the heat-moist exchanger. • Non-invasive imaging techniques: Lung ultrasound and Electrical impedance tomography. • Lung injury prediction score. Secondary dependent variables: • Therapeutic response in ARDS patients is defined as an improvement in PaO2/FiO2 24 hours after inclusion. • ARDS phenotypes defined by clinical characteristics (pulmonary / non- pulmonary cause) and by a four biomarker profile of plasma biomarkers (reactive / non-reactive). Other study parameters • Chronic co-morbidities and medication. • Acute physiology and chronic health evaluation score [33]. • ICU mortality, hospital mortality, 30– and 90–day and 1 year mortality. • For selected patients, who give explicit permission: assessment of long term physical and mental functioning. | — |
Contacts
AMC