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Lung Imaging for Ventilatory Setting in ARDS

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02149589
Recruitment Status : Completed
First Posted : May 29, 2014
Last Update Posted : February 28, 2018
Sponsor:
Collaborator:
AZUREA group
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

Tracking Information
First Submitted Date  ICMJE May 26, 2014
First Posted Date  ICMJE May 29, 2014
Last Update Posted Date February 28, 2018
Actual Study Start Date  ICMJE June 2014
Actual Primary Completion Date June 12, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
Mortality rate [ Time Frame: at day 90 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2014)
  • sRAGE & esRAGE plasmatic concentrations [ Time Frame: at Day 0 Day 1 Day 2 Day 3 Day 4 Day 6 . ]
  • Quality of life [ Time Frame: at Day 365 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Lung Imaging for Ventilatory Setting in ARDS
Official Title  ICMJE Lung Imaging for Ventilatory Setting in ARDS
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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Condition  ICMJE ARDS
Intervention  ICMJE Procedure: Mechanical ventilation
Study Arms  ICMJE
  • Experimental: Focal ARDS
    In Focal ARDS prone position will be promote early, with low PEEP and moderate Vt.
    Intervention: Procedure: Mechanical ventilation
  • non focal ARDS
    In non-Focal ARDS, Recruitment maneuvers, high PEEP and low V twill be used
    Intervention: Procedure: Mechanical ventilation
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: May 28, 2014)
420
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 2, 2018
Actual Primary Completion Date June 12, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE France
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02149589
Other Study ID Numbers  ICMJE CHU-0192
2013-A01756-39
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party University Hospital, Clermont-Ferrand
Study Sponsor  ICMJE University Hospital, Clermont-Ferrand
Collaborators  ICMJE AZUREA group
Investigators  ICMJE
Principal Investigator: Jean-Michel CONSTANTIN University Hospital, Clermont-Ferrand
PRS Account University Hospital, Clermont-Ferrand
Verification Date February 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP