Received: 29 April 2019
Accepted: 3 August 2019
First Online: 13 August 2019
Ethical committee and Consent to participate
: The study was approved by the local Ethics Committees (Vercelli, protocol no AslVC.Rian.14.02, approved on 11/09/2014; Catania, protocol no 479/CE, approved on 30/06/2015; Rimini, protocol no 1313, approved on 18/03/2015). Written informed consent was obtained from each participant before inclusion in the study, according to the local regulations and principles outlined in the Helsinki Declaration.
: All patients gave consent for data publication according to national regulations. All authors read the final manuscript and approved the submitted version.
: Dr. Navalesi’s research laboratory has received equipment and grants from Maquet Critical Care, Draeger and Intersurgical S.p.A. He also received honoraria/speaking fees from Maquet Critical Care, Orionpharma, Philips, Resmed, MSD and Novartis. Dr. Navalesi contributed to the development of the helmet Next, whose licence for patent belongs to Intersurgical S.P.A., and receives royalties for that invention. Dr. Longhini and Dr. Navalesi contributed to the development of a new device not discussed in the present study whose patent is in progress (European Patent application number EP20170199831). The remaining authors have disclosed that they do not have any Competing interests.