No registrations found.
ID
Source
Brief title
Health condition
ARDS, non-invasive diagnostic tests, early detection, octane
Dutch: ARDS, niet-invasieve diagnostische methoden, vroege detectie, octane
Sponsors and support
Intervention
Outcome measures
Primary outcome
Exhaled breath concentration of octane, measure by compact gas-chromatography.
Secondary outcome
• Volatile organic compounds in exhaled breath measured by gas-chromatography and mass-spectrometry.
• Protein patterns in fluid from the heat-moist exchanger.
• Non-invasive imaging techniques:
o Lung ultrasound
o Electrical impedance tomography.
• Lung injury prediction score.
• ARDS as defined by the Berlin Definition
• Therapeutic response in ARDS patients
• ARDS phenotypes defined by clinical characteristics and by a biomarker profile of plasma biomarkers
Background summary
The acute respiratory distress syndrome (ARDS) is a severe complication of critical illness characterized by acute onset, protein rich, pulmonary edema and is associated with mortality rates above 40%. Early diagnosis and monitoring are major challenges. The diagnosis is based on timing, chest-radiography, origin of edema and the oxygenation values. However, still in half of the cases the diagnosis was missed. (ref) Gas-chromatography mass-spectrometry (GC-MS) is used in exhaled breath analysis to obtain concentrations of volatile compounds (VOCs). A biomarker that was found to be associated with ARDS is octane. Since GC-MS is labour intensive, requires specialized personnel and is not available bedside, it is not suitable for use in the intensive care unit (ICU) setting. Therefore a smaller device was developed which can quantitatively measure octane in exhaled breath. This point of care prototype will be tested in clinical setting and will be compared with other non-invasive diagnostic tests. Goal of this study is (1) to evaluate the diagnostic accuracy of a point of care octane breath test for ARDS in intubated and mechanically ventilated ICU patients; (2) to evaluate the association between changes in exhaled octane concentrations and changes in the clinical characteristics of patients with ARDS; and (3) to compare the diagnostic and predictive (additive) accuracy of several non-invasive tests for ARDS.
Study objective
Octane concentrations in exhaled breath facilitate early detection of ARDS in ICU patients.
Study design
Within 48 hours after intubation untill a follow up of 90 days.
First measurement within 48 hours after intubation, second 24 hours later.
Intervention
NA
Meibergdreef 9
Lieuwe D.J. Bos
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666345
l.d.bos@amc.uva.nl
Meibergdreef 9
Lieuwe D.J. Bos
Amsterdam 1105 AZ
The Netherlands
+31 (0)20 5666345
l.d.bos@amc.uva.nl
Inclusion criteria
Intubated and mechanically ventilated for less than 48 hours.
Exclusion criteria
• Patient is expected to be deceased within 24 hours.
• Exhaled breath collection deemed inappropriate by the attending physicians.
• Active withdrawal from the study by the patient or his/her legal representative.
• Present admission to the ICU is a readmission.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL7170 |
| NTR-old | NTR7393 |
| Other | : NA |