Lung Imaging for Ventilatory Setting in ARDS

ARDS Clinical Trial

Official title:

Lung Imaging for Ventilatory Setting in ARDS

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02149589
• Other study ID #: CHU-0192
• Secondary ID: 2013-A01756-39
• Status: Completed
• Phase: N/A
• First received: May 26, 2014
• Last updated: February 27, 2018
• Start date: June 2014
• Est. completion date: February 2, 2018

Study information

• Verified date: February 2018
• Source: University Hospital, Clermont-Ferrand
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 420
• Est. completion date: February 2, 2018
• Est. primary completion date: June 12, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• ARDS

Intervention

Procedure:
• Mechanical ventilation

Locations

Country	Name	City	State
France	CHU de Clermont-Ferrand	Clermont-Ferrand

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand	AZUREA group

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality rate		at day 90
Secondary	sRAGE & esRAGE plasmatic concentrations		at Day 0 Day 1 Day 2 Day 3 Day 4 Day 6 .
Secondary	Quality of life		at Day 365