Lung Imaging for Ventilatory Setting in ARDS

Study Overview
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Brief Summary
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To compare in ARDS patients 2 ventilatory Strategies : One based on Lung Morphology (Focal versus non-Focal ARDS) versus ARDS networks Guidelines (PEEP based on FiO2). In Focal ARDS prone position will be promote early, with low PEEP and moderate Vt. In non-Focal ARDS, Recruitment maneuvers, high PEEP and low V twill be used. The investigators made the hypothesis that ventilation according to Lung morphology my decrease mortality at D90.

Detailed Description
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Early ARDS, less than 12 hours will be included. After Lung imaging, they will be randomized to a control group (PEEP/FiO2 according to ARDSnetwork tables) or an intervention arm. In this arm, mechanical ventilation will be set according to lung morphology. In patients with focal ARDS, prone position will be start quickly for at least 16 hours. After, A low PEEP and 8ml/kg of PBWwill be used. In non-focal ARDS, a recruitment maneuver followed by a high PEEP and a small tidal volume strategy will be used. In both arms, patients will be sedated and paralyzed during maximum 48 hours. As soon as PaO2/FiO2 > 200 mmHG, myorelaxant and sedation will be withdrawal. Pressure support ventilation will be used as soon as possible and weaning from ventilation will be checked everyday

Official Title
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Lung Imaging for Ventilatory Setting in ARDS

Conditions
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ARDS

Intervention / Treatment
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* Procedure: Mechanical ventilation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Man or female older than 18 years ARDS since less than 12 hours PaO2 / FiO2 < 200 avec une PEEP ≥ 5 (Berlin Moderate or severe) Exclusion Criteria: brain injury with high ICP BMT Liver Cirrhosis Child C Pregnancy Burns Morbid obese patients (BMI > 40) Moribund

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Focal ARDS<br>In Focal ARDS prone position will be promote early, with low PEEP and moderate Vt. | Procedure: Mechanical ventilation<br> <br> |
| Other: non focal ARDS<br>In non-Focal ARDS, Recruitment maneuvers, high PEEP and low V twill be used | Procedure: Mechanical ventilation<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality rate |  | at day 90 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sRAGE & esRAGE plasmatic concentrations |  | at Day 0 Day 1 Day 2 Day 3 Day 4 Day 6 . | 
| Quality of life |  | at Day 365 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ARDS, PEEP, Recruitment manoeuvres, Lung Morphology