Outcomes {12}
PRESSURE SORE, PRESSURE SORES
The primary effectiveness outcome is the proportion of patients developing at least one pressure sore of any stage at 36 h from randomization. The reason why this measure of effectiveness was chosen is that it is more clinically relevant than the overall number of pressure sores. Furthermore, 36 h seems to be an appropriate time point given that the time it takes for pressure sores to develop is extremely variable, but it might as well be very short.Secondary outcomes will be the onset, number, and stage of pressure sores and comfort during NIV measured at different time points (12, 24, 36, 48, 60, 72, 84, 96 h). At the same time points, the location of pressure sores per patient will also be recorded, i.e., forehead, nose bridge, left cheek, right cheek, chin, left periauricular, right periauricular, and occipital. The study will also monitor the number of patients that interrupts NIV due to discomfort, the presence/absence of eye irritation in relation to both oronasal and full face/hybrid mask, poor adherence to the protocol (e.g., duration of NIV treatment/day, interfaces changed and hygiene protocol application both during each 12-h protocol period) and the presence/absence and types of vasoactive medications, i.e., epinephrine, norepinephrine, vasopressin, dobutamine, dopamine, other. Further outcomes include the costs for intervention implementation (e.g., mask-related costs) and those related to the care of pressure sores (antibiotic treatment, specialist medical visits).