Comparison of Corticosteroids vs Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the ICU

Korábbi kezelés

• Previous diagnostic of asthma ("GINA" international guidelines)
• Previous inclusion in the present study

Más betegség

• Current and proven active SARS-CoV2 infection
• Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids, uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus, gastro-intestinal ulcer bleeding
• Underlying disease requiring chronic daily use of systemic steroids

Egyéb

• Pneumothorax at inclusion
• Extracorporeal life support (ECMO or ECCO2R) at inclusion
• Moribund patient
• Pregnancy
• Patients protected by law
• Exclusion period due to other interventional clinical trial enrolment which can influence primary outcome

• Patients aged ≥ 40 years
• Strongly suspected or documented COPD, defined by the presence of the following criterias:
  • Persistent respiratory symptoms (dyspnoea, chronic cough or sputum)
  • History of exposure to a risk factor such as tobacco smoke
  • If available, pulmonary function tests showing airflow limitation not fully reversible (post-bronchodilator ratio of FEV1/ FVC ratio < 0.7)
• Severe acute exacerbation, defined by the presence of the two following criteria:
  • COPD exacerbation defined by a change in the patient baseline respiratory symptoms and requiring a change in regular respiratory medication
  • Acute respiratory failure (polypnea ≥ 30 breaths.min-1 or use of accessory respiratory muscles) requiring mechanical ventilation, either invasive or NIV (implemented because of hypercapnic acidosis with PaCO2 ≥ 45 mmHg and pH ≤ 7.35).
• Admission to an ICU, a step-up unit or a respiratory care unit <24h
• Written inform consent from the patient or his surrogates. In patients who are not able to consent on admission an emergency inclusion procedure will be allowed, with a mandatory delayed consent.
• Affiliation to (or benefit from) French health insurance system.