Clinical trial NCT02149589: Lung Imaging for Ventilatory Setting in ARDS
Official title: Lung Imaging for Ventilatory Setting in ARDS
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: ARDS
Keywords: ARDS
PEEP
Recruitment manoeuvres
Lung Morphology
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
Collaborators: name: AZUREA group
First posted: 2014-05-29
Enrollment: 420
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Brief summary: 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: 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

Eligibility criteria: 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

Primary outcomes:
measure: Mortality rate
timeFrame: at day 90
Secondary outcomes:
measure: sRAGE & esRAGE plasmatic concentrations
timeFrame: at Day 0 Day 1 Day 2 Day 3 Day 4 Day 6 .
measure: Quality of life
timeFrame: at Day 365
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU de Clermont-Ferrand
Study officials:
affiliation: University Hospital, Clermont-Ferrand
name: Jean-Michel CONSTANTIN
role: PRINCIPAL_INVESTIGATOR
References:
citation: Blanchard F, Godet T, Pons S, Kapandji N, Jabaudon M, Degos V, Borao L, Bougle A, Monsel A, Futier E, Constantin JM, James A. One-year patient outcomes based on lung morphology in acute respiratory distress syndrome: secondary analysis of LIVE trial. Crit Care. 2022 Jun 4;26(1):159. doi: 10.1186/s13054-022-04036-7.
citation: Constantin JM, Jabaudon M, Lefrant JY, Jaber S, Quenot JP, Langeron O, Ferrandiere M, Grelon F, Seguin P, Ichai C, Veber B, Souweine B, Uberti T, Lasocki S, Legay F, Leone M, Eisenmann N, Dahyot-Fizelier C, Dupont H, Asehnoune K, Sossou A, Chanques G, Muller L, Bazin JE, Monsel A, Borao L, Garcier JM, Rouby JJ, Pereira B, Futier E; AZUREA Network. Personalised mechanical ventilation tailored to lung morphology versus low positive end-expiratory pressure for patients with acute respiratory distress syndrome in France (the LIVE study): a multicentre, single-blind, randomised controlled trial. Lancet Respir Med. 2019 Oct;7(10):870-880. doi: 10.1016/S2213-2600(19)30138-9. Epub 2019 Aug 6.
citation: Jabaudon M, Godet T, Futier E, Bazin JE, Sapin V, Roszyk L, Pereira B, Constantin JM; AZUREA group. Rationale, study design and analysis plan of the lung imaging morphology for ventilator settings in acute respiratory distress syndrome study (LIVE study): Study protocol for a randomised controlled trial. Anaesth Crit Care Pain Med. 2017 Oct;36(5):301-306. doi: 10.1016/j.accpm.2017.02.006. Epub 2017 Mar 18.