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CompletedNCT02149589Updated Apr 21, 2026

Lung Imaging for Ventilatory Setting in ARDS

An interventional study of Mechanical ventilation in ARDS, sponsored by University Hospital, Clermont-Ferrand. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.

Sponsored by University Hospital, Clermont-Ferrand · Not applicable, Interventional, and Other

Phase
Not applicable
Study type
Interventional
Enrollment
420
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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

02

Conditions studied

  • ARDS

Keywords

  • ARDS
  • PEEP
  • Recruitment manoeuvres
  • Lung Morphology
03

In context

Lead sponsor

University Hospital, Clermont-Ferrand is the lead sponsor of 841 studies on the registry; 178 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • brain injury with high ICP
  • BMT Liver Cirrhosis Child C Pregnancy Burns Morbid obese patients (BMI > 40) Moribund
05

Study design

Phase
Not applicable
Primary purpose
Other
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
420 participants (actual)

Study arms

  • Experimental
    Focal ARDS

    In Focal ARDS prone position will be promote early, with low PEEP and moderate Vt.

    Procedure: Mechanical ventilation

  • Other
    non focal ARDS

    In non-Focal ARDS, Recruitment maneuvers, high PEEP and low V twill be used

    Procedure: Mechanical ventilation

Interventions

  • ProcedureMechanical ventilation
06

What researchers measure

Primary outcomes

  1. Mortality rate

    Time frame: at day 90

Secondary outcomes

  1. sRAGE & esRAGE plasmatic concentrations

    Time frame: at Day 0 Day 1 Day 2 Day 3 Day 4 Day 6 .

  2. Quality of life

    Time frame: at Day 365

07

Study locations

1 site
  • CHU de Clermont-Ferrand
    Clermont-Ferrand, 63003, France
08

References and documents

Publications

  • 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. PubMed 31399381 ↗
  • 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. PubMed 35659328 ↗
  • 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. PubMed 28323236 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 21, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02149589
Lead sponsor
University Hospital, Clermont-Ferrand
Collaborators
AZUREA group
Responsible party
Sponsor
First posted
May 29, 2014
Start date
Jun 2014
Primary completion
Jun 12, 2017
Completion
Feb 2, 2018
Last update
Apr 21, 2026

Study contacts

Jean-Michel CONSTANTIN
principal investigator · University Hospital, Clermont-Ferrand
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.

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