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Lung Imaging for Ventilatory Setting in ARDS

Lung Imaging for Ventilatory Setting in ARDS

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02149589
Enrollment
420
Registered
2014-05-29
Start date
2014-06-01
Completion date
2018-02-02
Last updated
2026-04-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

ARDS

Keywords

ARDS, PEEP, Recruitment manoeuvres, Lung Morphology

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

Interventions

PROCEDUREMechanical ventilation

Sponsors

University Hospital, Clermont-Ferrand
Lead SponsorOTHER
AZUREA group
CollaboratorUNKNOWN

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Mortality rateat day 90

Secondary

MeasureTime frame
sRAGE & esRAGE plasmatic concentrationsat Day 0 Day 1 Day 2 Day 3 Day 4 Day 6 .
Quality of lifeat Day 365

Countries

France

Contacts

PRINCIPAL_INVESTIGATORJean-Michel CONSTANTIN

University Hospital, Clermont-Ferrand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 22, 2026