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Bedside exhaled breath octane measurements for the diagnosis and monitoring of acute respiratory distress syndrome in invasively ventilated patients

Bedside exhaled breath octane measurements for the diagnosis and monitoring of acute respiratory distress syndrome in invasively ventilated patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON21219
Enrollment
500
Registered
2019-12-11
Start date
2019-03-01
Completion date
Unknown
Last updated
2024-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute respiratory distress syndrome

Interventions

None

Sponsors

Amsterdam UMC location AMC
Lead Sponsor

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

MeasureTime 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

MeasureTime 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

Public ContactLieuwe Bos

AMC

l.d.bos@amsterdamumc.nl-

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)