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

Recruiting

• Conditions: Acute respiratory distress syndrome

• Registration Number: NL-OMON21219
• Lead Sponsor: Amsterdam UMC location AMC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 28 February 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Not specified
• Target Recruitment: 500

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

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.

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary independent variable<br>Exhaled breath concentration of octane, measured by compact gas- chromatography.<br><br>Primary dependent variable<br>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.<br><br>Primary outcome<br>Optimal sensitivity and specificity and cutoff for breath octane concentration in diagnosis of ARDS.