Acute Respiratory Distress Syndrome (ARDS)
Conditions
Keywords
ARDS, computed tomography, cyclic hyperinflation, mechanical ventilation
Brief summary
This study aims to validate a semi-automatized method to quantify cyclic hyperinflation on CT-scan of ARDS patients. The gold standard will be cyclic hyperinflation assessed on the same CT scan, using manual segmentation of the lung.
Interventions
OTHERARDS patients
The patient will be installed on the scanner bed. Two series of tomographic sections will be acquired: one during an expiratory break, the other during an inspiratory pause. cyclic hyperinflation measured by semi-automatic segmentation and by manual segmentation
Sponsors
Hospices Civils de Lyon
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* ARDS patients defined by the Berlin definition * invasive mechanical ventilation with an arterial oxygen pressure (PaO2)/inspired fraction of oxygen (FiO2) ratio ≤ 200 mm Hg * Indication of CT scan identified by the clinician in charge * oesophageal catheter already inserted
Exclusion criteria
* requirement of contrast agent for a chest CT-scan * ARDS criteria present for more than 72 hours * Chronic Obstructive Pulmonary Disease (COPD) on a previous lung function test * pneumothorax or bronchopleural fistula * patient without both sedation and neuromuscular blocking agents * contra-indication to transport to the imaging facility * treatment with extracorporeal membrane oxygenation or extracorporeal carbon dioxide (CO2) removal * Latex or curare allergy * patient previously included in the study * pregnancy * patient under limitation of care * patient under an exclusion period following inclusion in another clinical trial * patient under a legal protective measure * patient unaffiliated with social security * inform consent not obtained by next of kin
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| cyclic hyperinflation measured by semi-automated segmentation | 2 hours after inclusion | Bias and precision of semi-automated measure will be assessed with the Bland and Altman Technique, using cyclic hyperinflation by manual segmentation as a reference |
| cyclic hyperinflation measured by manual segmentation | 2 hours after inclusion | Bias and precision of semi-automated measure will be assessed with the Bland and Altman Technique, using cyclic hyperinflation by manual segmentation as a reference |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| prevalence of cyclic hyperinflation on CT scan | 2 hours after inclusion | cyclic hyperinflation assessed by manual segmentation on CT scan |
| area under receiver operating characteristic (ROC) curve of respiratory system driving pressure to detect cyclic hyperinflation assessed by manual segmentation | 2 hours after inclusion | — |
| area under ROC curve of transpulmonary driving pressure to detect cyclic hyperinflation assessed by manual segmentation | 2 hours after inclusion | — |
Countries
France
Outcome results
None listed