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Article History

Received: 21 November 2021

Accepted: 10 February 2022

First Online: 24 February 2022

Declarations

:

: The study will be conducted in adherence to national and international standards of Good Clinical Practice (GCP). The protocol including amendments, as well as written information and consent forms, has been approved by the regional ethics committee of the Capital Region of Denmark prior to initiation of the trial (Approval id H-16033436). The study protocol was reviewed at the Danish Medicines Agency, which did consider the trial to be a pharmaceutical study and thus waived approval, and a data handling agreement has been approved by the relevant authority (Approval id RH-2016-373).Eligible subjects are unconscious and accordingly incapacitated to give informed consent in the acute setting. Since both blood pressure and oxygenation targets are within normal ranges supported by international guidelines and that risks to the patients are considered acceptable, and that similar information cannot be obtained from non-comatose or animal experiments, the Ethics Committee gave permission to include the patients without consent, and obtained a consent from a relative and legal surrogate. If the patients regain consciousness, he or she will be asked to give informed consent.

: The model consent forms given to the legal surrogate, next of kin, and the patient are available on request. The consent forms are all approved by the regional ethical committee. Forms are in the Danish language. Please also see “Ethics approval and consent to participate {24}” and “Who will take informed consent? {26a}” sections for consent to participate and the procedure for obtaining consent, respectively.

: The authors declare they have no competing interests.