Who will take informed consent? {26a}
ARF
ARF, DISEASE
Local principal investigators, sub-investigators, trained research nurses, or residents will introduce the trial to the patients or to their legal representatives in case the patients are unable to understand due to communicative or cognitive limitations. The same operators will obtain written consent before randomization from all eligible patients or their legal representatives. Informed consent will be collected according to current national regulations. If patients with legal representatives regain their ability to consent, a second written consent will be requested. In circumstances where patients are unable to consent due to the nature of the underlying disease process (e.g., hypercapnic ARF) or treatments (e.g., sedative medications, mechanical ventilation), in the absence of a legal representative, patients will be randomized, and written consent will be obtained once patients regain their ability to consent. If patients understand and consent to the study, but they are not able to sign a written consent, they will be allowed to verbally agree in the presence of a witness. This verbal consent will then be documented in the medical records. Once the clinical situation improves, the patient will be asked to sign the consent form before being discharged. If a patient dies before a written informed consent can be obtained, his/her data may also potentially be used.At any time during the clinical study, patients can freely withdraw their informed consent. In this case, no further data will be collected, and the data already collected will be deleted. Participants who abandon the study will be replaced with the aim of reaching the number of subjects envisaged by the sample size, with the possible need to extend the inclusion period.