Evaluation of patient skin breakdown and comfort with a new face mask for non-invasive ventilation: a multi-center study

To evaluate patient comfort, skin breakdown and eye irritation when comparing a prototype face mask (PM) and conventional face masks (CMs) during non-invasive ventilation. Eight centers (intensive or intermediate care units). Multicenter randomized study. Patients with acute respiratory failure of different etiologies. Patients were randomized to CMs or PM when ventilation was expected to last at least 12 consecutive hours a day for two consecutive days. Patient comfort, skin breakdown and eye irritation, assessed by means of standardized scoring systems, were measured after 24 and 48 h and before discontinuing ventilation. Hundred ninety-four patients were randomized. Forty-seven patients were finally enrolled: PM (24) and CMs (23). Ventilator settings were similar in the two groups at the beginning of the treatment and after 24 and 48 h. Skin breakdown was significantly higher in the CMs group over the study period ( p