Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Versailles Hospital
Age
40–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
1. Patients aged ≥ 40 years
2. 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)
3. 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).
4. Admission to an ICU, a step-up unit or a respiratory care unit \<24h
5. 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.
6. Affiliation to (or benefit from) French health insurance system.
You may not be if
1. Previous diagnostic of asthma ("GINA" international guidelines)
2. Current and proven active SARS-CoV2 infection
3. Contra-indication of systemic corticosteroids treatment: allergy to corticosteroids, uncontrolled severe arterial hypertension, uncontrolled diabetes mellitus, gastro-intestinal ulcer bleeding
4. Underlying disease requiring chronic daily use of systemic steroids
5. Pneumothorax at inclusion
6. Extracorporeal life support (ECMO or ECCO2R) at inclusion
7. Moribund patient
8. Pregnancy
9. Patients protected by law
10. Exclusion period due to other interventional clinical trial enrolment which can influence primary outcome
11. Previous inclusion in the present study
Clareo Health | Comparison of Corticosteroids vs Placebo on Duration of Ventilatory Support During Severe Acute Exacerbations of COPD Patients in the ICU
