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

Objective: To evaluate patient comfort, skin break-down and eve irritation when comparing a prototype face mask (PM) and conventional face masks (CMs) during non-invasive ventilation. Setting and design: Eight centers (intensive or intermediate care units). Multicenter randomized study. Populations: Patients with acute respiratory failure of different etiologies. Interventions: 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. Results: 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 be-inning of the treatment and after 24 and 48 h. Skin breakdown was significantly higher L in the CMs group over the study period (p<0.001). Patient comfort was higher in the PM group after 24 and 48 h (p=0.008 and p<0.001, respectively). Eye irritation was absent in both groups after 24 h and did not differ significantly after 48 h (p=0.539). Before ventilation was discontinued skin breakdown and patient comfort were significantly higher in the CMs group, when compared to the PM group (p<0.001 and p=0.003, respectively). Eye irritation was slightly higher in the PM versus CMs group (p=0.21). The time on ventilation was not significantly different between the two groups (p=0.830). Conclusion: The PM significantly reduced skin breakdown while improving patient comfort, compared to the CMs.