Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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.


Condition or disease Intervention/treatment Phase
ARDS Procedure: Mechanical ventilation Not Applicable

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

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 420 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Lung Imaging for Ventilatory Setting in ARDS
Actual Study Start Date : June 2014
Actual Primary Completion Date : June 12, 2017
Actual Study Completion Date : February 2, 2018

Arm Intervention/treatment
Experimental: Focal ARDS
In Focal ARDS prone position will be promote early, with low PEEP and moderate Vt.
Procedure: Mechanical ventilation
non focal ARDS
In non-Focal ARDS, Recruitment maneuvers, high PEEP and low V twill be used
Procedure: Mechanical ventilation



Primary Outcome Measures :
  1. Mortality rate [ Time Frame: at day 90 ]

Secondary Outcome Measures :
  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 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02149589


Locations
Layout table for location information
France
CHU de Clermont-Ferrand
Clermont-Ferrand, France, 63003
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
AZUREA group
Investigators
Layout table for investigator information
Principal Investigator: Jean-Michel CONSTANTIN University Hospital, Clermont-Ferrand
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT02149589    
Other Study ID Numbers: CHU-0192
2013-A01756-39
First Posted: May 29, 2014    Key Record Dates
Last Update Posted: February 28, 2018
Last Verified: February 2018
Keywords provided by University Hospital, Clermont-Ferrand:
ARDS
PEEP
Recruitment manoeuvres
Lung Morphology