The Pilot Trial of Invasive Mechanical Ventilation for Critical Care Patients

In the pilot trial, 3,024 critically ill patients received invasive mechanical ventilation screened for eligibility of whom 37 were excluded. Over the planned 36 months of enrollment, we anticipated that 2,250 patients would be enrolled and the number of VELator free days would have a median of 22 in a quartile range of 0 to 25. And you can see here listed the exploratory clinical organ function safety outcomes that were re-specified and collected. With an alpha of 0.05, we calculated that we have 92% statistical power to detect a difference to VELatorfree days between any two of the three trial groups.