Botta, Michela http://orcid.org/0000-0003-2675-4604
Tsonas, Anissa M.
Sinnige, Jante S.
De Bie, Ashley J. R.
Bindels, Alexander J. G. H.
Ball, Lorenzo
Battaglini, Denise
Brunetti, Iole
Buiteman–Kruizinga, Laura A.
van der Heiden, Pim L. J.
de Jonge, Evert
Mojoli, Francesco
Robba, Chiara
Schoe, Abraham
Paulus, Frederique
Pelosi, Paolo
Neto, Ary Serpa
Horn, Janneke
Schultz, Marcus J.
Botta, Michela
Tsonas, Anissa M.
Sinnige, Jante S.
De Bie, Ashley J. R.
Bindels, Alexander J. G. H.
Ball, Lorenzo
Battaglini, Denise
Brunetti, Iole
Buiteman–Kruizinga, Laura A.
van der Heiden, Pim L. J.
de Jonge, Evert
Mojoli, Francesco
Robba, Chiara
Schoe, Abraham
Paulus, Frederique
Pelosi, Paolo
Neto, Ary Serpa
Horn, Janneke
Schultz, Marcus J.
,
Funding for this research was provided by:
ZonMw (852002031)
Article History
Received: 1 March 2022
Accepted: 7 April 2022
First Online: 23 April 2022
Declarations
:
: Central ethical approval has been confirmed from the Institutional Research Board of the Amsterdam UMC, location AMC (approval number 2020_146#B2020557) on October 1, 2020; recruitment at other centers is started as soon as local ethical approval is obtained for the other centers. The Institutional Research Board of the Amsterdam UMC, location AMC, is notified on all amendments. Local investigators are reported on and trained in important protocol modifications, if this happens. Deferred informed consent is obtained from all patients, or their relatives when needed. Should they choose to withdraw from the trial, they are asked if they agree that their data can still be used. There are no biological specimens stored. The sponsor/investigator has a liability insurance, which is in accordance with article 7 subsection 6 of the WMO. As this study compares two ventilation strategies used for standard care, an exception from the requirement for insurance to cover for damage to research subjects through injury or death caused by the study is applicable.
: Not applicable.
: Prof M.J. Schultz is since January 2022 Team Leader Medical Affairs at Hamilton Medical AG, Bonaduz, Switzerland. The other authors declare that they have no competing interests.