Adverse event reporting and harms {22}
dryness of the mouth, redness, hypersensitivity
ADVERSE EVENTS, MINOR, PRESSURE SORES, SECONDARY, HYPERSENSITIVITY
Interfaces for noninvasive ventilation should be considered as a non-significant risk device according to the definition given from the Food and Drug Administration. Besides, the present randomized controlled trial does not intend to investigate a new interface but the protocolized rotational use of commercially available interfaces. As patients with contraindications to NIV/with known hypersensitivity to skin protective devices will be excluded from the study, the potential for serious adverse events related to a protocolized rotation use of interfaces appears remote. Possible minor adverse events consequent to the use of noninvasive ventilation interfaces consist of pressure sores, dryness of the mouth, eye redness, and discomfort. All these information will be recorded and reported as primary and secondary outcomes of the study.