Lung Imaging for Ventilatory Setting in ARDS

April 16, 2026 updated by: University Hospital, Clermont-Ferrand

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Study Type

Interventional

Enrollment (Actual)

420

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Clermont-Ferrand, France, 63003
        • CHU de Clermont-Ferrand

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Mortality rate
Time Frame: at day 90
at day 90

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Clermont-Ferrand

Collaborators

AZUREA group

Investigators

  • Principal Investigator: Jean-Michel CONSTANTIN, University Hospital, Clermont-Ferrand

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2014

Primary Completion (Actual)

June 12, 2017

Study Completion (Actual)

February 2, 2018

Study Registration Dates

First Submitted

May 26, 2014

First Submitted That Met QC Criteria

May 28, 2014

First Posted (Estimated)

May 29, 2014

Study Record Updates

Last Update Posted (Actual)

April 21, 2026

Last Update Submitted That Met QC Criteria

April 16, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CHU-0192
  • 2013-A01756-39

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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