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Article History

Received: 31 August 2020

Accepted: 24 November 2020

First Online: 14 December 2020

Ethics approval and consent to participate

: The study protocol was approved by “Comitato Etico Sezione Area Centro” Ethics Committee (approval no. 245—October 24, 2017, Catanzaro, Italy) and by the local ethics committee of all the study centers.

: Written informed consent for publication was obtained from each participant enrolled or legal representatives.

: Dr. Cortegiani, Prof. Giarratano and Prof. Gregoretti declare a patent pending, in association with the University of Palermo—Italy (No. 102019000020532—Italian Ministry of Economic Development), not discussed in the present study. Prof. Gregoretti received honoraria for lectures or consultancies from Philips, Resmed, Vivisol, OrionPharma, Origin (not relevant to this protocol). Prof. Enrico Clini received fees for lectures from Chiesi, Astra-Zeneca, Menarini, Guidotti_Malesci, and AlfaSigma (not relevant to this protocol). Prof. Stefano Nava’s institution received unrestricted research grant from Fisher and Paykel. Prof. Paolo Navalesi’s institution received funding from Maquet Critical Care, Draeger, and Intersurgical S.p.A.; he received honoraria/speaking fees from Maquet Critical Care, Orionpharma, Philips, Resmed, Merck Sharp & Dome, and Novartis; he disclosed that he contributed to the development of the helmet Next, whose license for patent belongs to Intersurgical S.P.A., and receives royalties for that invention. Prof. Federico Longhini and Prof. Paolo Navalesi contributed to the development of a device not discussed in the present study whose patent is in progress (European Patent application number EP20170199831). Dr. Paolo Groff received honoraria for lectures from Aspen Pharmaceuticals and Menarini Pharmaceuticals (not relevant to this study). Dr. Luigi Vetrugno received travel support for congress lecture by Cook Medical. The remaining authors have disclosed that they do not have any conflicts of interest.