Article History
Received: 9 February 2023
Accepted: 30 June 2023
First Online: 27 July 2023
Conflicts of Interest
: AL is a minority shareholder in Neuron Guard S.R.L., the company that developed the prototypes used in the study. AL also receives consultancy and speaker fees from Becton, Dickinson and Company (Berkshire, UK) for work related to target temperature management, which is not directly associated with this study. EB is supported by the Medical Research Council (grant no.: MR N013433-1) and the Gates Cambridge Scholarship. This work complies with the CONSORT checklist.
: The study protocol received ethics approval by the East of England – Cambridge Central Research Ethics Committee on the 9th of January 2019, Research Ethics Committee reference 19/EE/0001.
: All patients were comatose and therefore lacking capacity to consent their participation to the study. Whenever possible, a next of kin acting as a “consultee” for the patient was identified by the research team, and their opinion sought about their perceived participant’s wishes and feelings in relation to the participating in the study. A member of the research team approached the consultee to explain the study and its implications. Study participants were free to withdraw, or be withdrawn by their consultee if appropriate, at any point in the study, and they needed not state a reason. Where it proved impossible to contact consultees either in person, or by telephone, within 48 h post admission, we recruited study participants by identifying a nominated consultee, who was not part of the research team, such as the Consultant Neurosurgeon and Critical Care Physician in charge of the patient’s care.
: National Health Service Health Research Authority, SELETHERM 1.2 IRAS ID 248587, .