Created at Source Raw Value Validated value
Oct. 26, 2020, 8:29 a.m. oms

It is expected to evaluate the days without respiratory support (supplemental oxygen; CNAF; NIV; VM; ECMO) in 15 days. A live day without respiratory support was defined as any day on which the patient did not receive supplemental oxygen or invasive or non-invasive mechanical ventilation; from randomization to the 15th. Considering an average of 11 days and a standard deviation of 5 days in free days of ventilatory support; 110 patients (55 for each arm) will be sufficient to detect an average difference of 3 days between the study groups (experimental vs control); with 80% power and a two-tailed alpha of 0; 05. A value of 0 will be assigned to patients who died during the 15-day window.

It is expected to evaluate the days without respiratory support (supplemental oxygen; CNAF; NIV; VM; ECMO) in 15 days. A live day without respiratory support was defined as any day on which the patient did not receive supplemental oxygen or invasive or non-invasive mechanical ventilation; from randomization to the 15th. Considering an average of 11 days and a standard deviation of 5 days in free days of ventilatory support; 110 patients (55 for each arm) will be sufficient to detect an average difference of 3 days between the study groups (experimental vs control); with 80% power and a two-tailed alpha of 0; 05. A value of 0 will be assigned to patients who died during the 15-day window.