Patients will be prospectively recruited among patients admitted to 10 French ICUs. Patients will be considered eligible for enrolment if they fulfil the inclusion criteria and none of the exclusion criteria, as defined in box 1. A flow diagram of the R2D2-ICU trial is presented in figure 1.

Inclusion criteria

Adult ≥18 years.

Invasive mechanical ventilation expected for at least ≥48 hours.

Invasive mechanical ventilation in the ICU for a duration inferior to 6 hours.

Eligible for physical restraint prescription.∗

Exclusion criteria

Documented delirium prior to ICU admission according to the CAM-ICU.

History of dementia (mini-mental test <24).

Alcohol withdrawal syndrome expected.

Admission for any neurological disease including postcardiopulmonary resuscitation (cardiac arrest, stroke, traumatic brain injury, meningoencephalitis and status epilepticus).

Serious auditory or visual disorders.

Unable to understand French.

Pregnant or lactating women.

SAPS II>65 points at screening.

Do-not-resuscitate orders.

No affiliation to a social security regimen (beneficiary or assignee).

The patient or person of confidence (if present at the time of inclusion) opposing the patient’s participation in research.

The patient is already involved in another interventional clinical research whose main objective is related to delirium.

∗Not already restrained because of a previous written medical prescription.

CAM-ICU, Confusion Assessment Method-ICU; ICU, intensive care unit; SAPS2, Simplified Acute Physiology Score 2.