Status:
UNKNOWN
Early Spontaneous Breathing in Acute Respiratory Distress Syndrome
Lead Sponsor:
University Hospital, Angers
Conditions:
Acute Respiratory Distress Syndrome
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The care of acute respiratory distress syndrome (ARDS) has been significantly improved by learning from experimental and physiological research works and by a series of randomized controlled trials. T...
Eligibility Criteria
Inclusion
- Within 1 week of a known clinical insult or new or worsening respiratory symptoms
- Intubation and mechanical ventilation
- Bilateral opacities - not fully explained by effusions, lobar/lung collapse, or nodules lung
- Report PaO2 / FiO2 ≤ 200 mmHg with a PEP of at least 5 cmH2O
- Respiratory failure not fully explained by cardiac failure or fluid overload
- Criteria 1, 2 and 3 presents jointly for less than 48 hours
- Consent to participate obtained either from the patient himself or from a relative.
Exclusion
- Age \< 18 years
- Pregnancy
- Predictable duration of the mechanical ventilation on endotracheal tube lower than 48 hours
- Patient being in period of exclusion further to the participation in another biomedical study
- intracranial hypertension (suspected or confirmed)
- known or suspected COPD
- Chronic respiratory failure treated by long-term oxygen and / or long-term respiratory support
- Morbid obesity defined as weight greater than 1 kg / cm
- Sickle Cell Disease
- Marrow recent transplant, post-chemotherapy aplasia
- Widened burns (\> 30% body surface area)
- Severe hepatic cirrhosis (Child-Pugh C)
- Pneumothorax (drained or not)
- Treatment with extracorporeal support (ECMO)
- Decision of active therapeutic limitation
- Unavailability of the model of respirator that must be used in the study
- Failure to obtain a consent by persons authorized to do so.
- Patient under law protection.
- Person non-beneficiary of a social security system
Key Trial Info
Start Date :
February 28 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2019
Estimated Enrollment :
702 Patients enrolled
Trial Details
Trial ID
NCT01862016
Start Date
February 28 2013
End Date
May 1 2019
Last Update
March 19 2019
Active Locations (1)
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1
Medical Intensive Care Unit, University Hospital of Angers
Angers, France, 49933