Randomized Controlled Trial Comparing Two Different Ventilatory Strategies in Acute Respiratory Distress Syndrome Due to Community-acquired Pneumonia. The control strategy will be based on ARDSNet approach. The intervention group will receive a different ventilatory strategy based on positive end-expiratory pressure tailored according to compliance and limited driving pressure.
There is no consensus on the optimal ventilatory management of patients with community-acquired pneumonia that require mechanical ventilation and have acute respiratory distress syndrome. The traditional ventilatory approach (ARDSNet) is based on a fixed table for both end respiratory positive end-expiratory pressure according to inspired oxygen fraction. Alternatively, a strategy that tailors positive end-expiratory pressure according to compliance and limits driving pressure may be beneficial, but evidence is lacking. We will perform an open label randomized controlled trial comparing both strategies.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
214
Positive end-expiratory pressure will be tailored during a decremental maneuver (without a formal alveolar recruitment maneuver). The best positive end-expiratory pressure will be defined as the one associated with the higher respiratory system compliance, up to 20 cmH2O. Plateau pressure limit will be 30 cmH2O. If driving pressure remains elevated after optimal PEEP setting, tidal volume will be reduced to keep driving pressure below 14 cmH2O.
Positive end-expiratory pressure will be set according to fixed inspired oxygen fraction values.
Associação Evangélica Beneficente de Londrina - Hospital Evangélico de Londrina
Londrina, Paraná, Brazil
Hospital São José
Criciúma, Santa Catarina, Brazil
Hospital Nereu Ramos
Florianópolis, Santa Catarina, Brazil
Centro Hospitalar Unimed
Joinville, Santa Catarina, Brazil
Mechanical ventilation free days
Number of days patient remains independent of mechanical ventilation
Time frame: 28 days
Hospital Mortality
Whether the patient perished or not during hospitalization
Time frame: 90 days
Intensive Care Unit Mortality
Whether the patient perished or not during intensive care unit stay, truncated at 28 days
Time frame: 90 days
Need for rescue therapies for refractory hypoxemia
Need for extracorporeal membrane oxygenation, alveolar recruitment maneuver, or inhaled nitroux oxide, truncated at 28 days
Time frame: 28 days
Occurrence of barotrauma
Occurrence of either subcutaneous emphysema, pneumothorax or pneumatocele, truncated at 28 days
Time frame: 28 days
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Hospital do Coracao
São Paulo, Brazil
BP-A Beneficiência Portuguesa de São Paulo
São Paulo, Brazil