Item | Screening/baseline | Final visit | ||
Visit 1 | Visit 2 | Visit 3 | Visit 4 | |
Date | H0 | H72 | Day 28 or ICU discharge | Day 90 |
Clinical evaluation | X | X | X | |
Informed consent | X | |||
Medical history | X | |||
Demography | X | |||
Physical examination | X | X | X | |
Vital signs* | X | X | X | |
Routine laboratory testing† | X | X | X | |
Experimental treatment | X | X | X | |
Endpoints evaluation° | X | X | X | x |
Adverse events recording | X | X | X |
*Includes haemodynamic parameters (arterial pressure, heart rate, vasopressors use), respiratory rate, ventilatory parameters (respiratory rate and pulse oxymetry).
†Arterial blood gases, as usually performed for the daily patient care during the first 72 hours if an arterial catheter was in place. Supplementary blood gases will be done according to the clinical state of the patient. Blood gases will be also done before the reintubation if an acute respiratory failure following extubation occurs.
ICU, intensive care unit.