NCT02149589

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
420

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Jun 2014

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 26, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 29, 2014

Completed
3 days until next milestone

Study Start

First participant enrolled

June 1, 2014

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 12, 2017

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 2, 2018

Completed
Last Updated

April 21, 2026

Status Verified

April 1, 2026

Enrollment Period

3 years

First QC Date

May 26, 2014

Last Update Submit

April 16, 2026

Conditions

ARDS

Keywords

ARDSPEEPRecruitment manoeuvresLung Morphology

Outcome Measures

Primary Outcomes (1)

  • Mortality rate

    at day 90

Secondary Outcomes (2)

  • sRAGE & esRAGE plasmatic concentrations

    at Day 0 Day 1 Day 2 Day 3 Day 4 Day 6 .

  • Quality of life

    at Day 365

Study Arms (2)

Focal ARDS

EXPERIMENTAL

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

Procedure: Mechanical ventilation

non focal ARDS

OTHER

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

Procedure: Mechanical ventilation

Interventions

Mechanical ventilationPROCEDURE
Focal ARDSnon focal ARDS

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Man or female older than 18 years
  • ARDS since less than 12 hours
  • PaO2 / FiO2 \< 200 avec une PEEP ≥ 5 (Berlin Moderate or severe)

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Related Publications (3)

  • 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.

    PMID: 31399381RESULT

  • 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.

    PMID: 35659328DERIVED

  • 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.

    PMID: 28323236DERIVED

MeSH Terms

Interventions

Respiration, Artificial

Intervention Hierarchy (Ancestors)

Airway ManagementTherapeuticsResuscitationEmergency TreatmentRespiratory Therapy

Study Officials

  • Jean-Michel CONSTANTIN

    University Hospital, Clermont-Ferrand

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2014

First Posted

May 29, 2014

Study Start

June 1, 2014

Primary Completion

June 12, 2017

Study Completion

February 2, 2018

Last Updated

April 21, 2026

Record last verified: 2026-04

Locations

FR(1)