Cortegiani, Andrea http://orcid.org/0000-0003-1416-9993
Longhini, Federico
Carlucci, Annalisa
Scala, Raffaele
Groff, Paolo
Bruni, Andrea
Garofalo, Eugenio
Taliani, Maria Rita
Maccari, Uberto
Vetrugno, Luigi
Lupia, Enrico
Misseri, Giovanni
Comellini, Vittoria
Giarratano, Antonino
Nava, Stefano
Navalesi, Paolo
Gregoretti, Cesare
Article History
Received: 29 March 2019
Accepted: 10 June 2019
First Online: 22 July 2019
Ethics approval and consent to participate
: The Ethics Committee of the coordinating center approved the study protocol on 24 October 2017 (“Comitato Etico sezione Area Centro—N°245”). The local ethics committees or institutional review boards of participating centers have approved the study protocol. Consent to participate in the trial will be obtained from every patient according to national regulation.
: Not applicable.
: Prof. Stefano Nava’s institution received an 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; and he discloses 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 fees for lectures from Aspen Pharmaceuticals and Menarini Pharmaceuticals (not relevant to this protocol). Prof. Cesare Gregoretti received fees for lectures or consultancies from Philips, Resmed, Vivisol, OrionPharma and Origin (not relevant to this protocol). The remaining authors disclose that they have no conflicts of interest.