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 breakdown and eye 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 beginning of the treatment and after 24 and 48 h. Skin breakdown was significantly higher 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.