Table 1.

Study objectives and associated endpoints

Primary objective	Primary endpoint
To assess whether a restrictive use of PR, in comparison to a systematic use, decreases delirium duration during the first 14 days after randomisation.	Delirium or coma-free days are defined by the number of days alive without delirium (measured by CAM-ICU) or coma (measured by RASS) during the first 14 days (day 14) after randomisation (day 0).
Secondary objectives	Secondary endpoints
To evaluate the effect of restrictive use of PR between day 0 and day 14 on: Incidence of delirium Agitation duration. Exposure to opioids. Exposure to propofol. Exposure to benzodiazepines. Exposure to antipsychotic agents. Exposure to dexmedetomidine. Exposure to MV. Patient mobility according to the visual mobilisation score. Incidence of self-extubation and device removal. Skin lesions occurrence.	Percentage of patients with at least 1 day of delirium (positive CAM-ICU) between day 0 and day 14. Number of days alive with agitation (RASS score ≥ +2) between day 0 and day 14. Total cumulative dose of opioids infusion between day 0 and day 14. Total cumulative dose of propofol infusion between day 0 and day 14. Total cumulative dose of benzodiazepines infusion between day 0 and day 14. Total cumulative dose of antipsychotics infusion between day 0 and day 14. Total cumulative dose of dexmedetomidine infusion between day 0 and day 14. Invasive MV-free hours between day 0 and day 14. Median of mobilisation capacity and rate of patients >2 on a visual scale (SOMS) ranging from 0 (no mobilisation) to 4 (ambulation) between day 0 and day 14. Rate of patients with at least one self-extubation or any device removal between day 0 and day 14. Rate of patients with pressor ulcer on the wrists and with other bedsores and their severity according to the National Pressure Ulcer Advisory Panel (at least one ulcer of grade III or IV per patient) between day 0 and day 14.
To evaluate the effect of restrictive use of PR until ICU Discharge on: Delirium duration until ICU discharge: Patients will be considered ‘ready for discharge’ as soon as all clinical conditions for ICU discharge will be fulfilled. ICU and hospital lengths of stay. In-ICU and in-hospital mortality.	Number of days in delirium until ICU discharge. Number of days of ICU stay and hospital stay (up to day 90). Death rate during ICU stay and hospital stay (up to day 90).
To evaluate the effect of restrictive use of PR at day 90 (after inclusion) on the global assessment of motor and cognitive functions and post-traumatic stress disorder .	Rate of patients with altered cognitive capabilities defined as a score on the Mini-Mental State Examination ≤24 points. Rate of patients with a frontal syndrome is defined as a score on the FAB<15 points. Rate of patients with a possible diagnosis of post-traumatic stress disorder is defined as a score on the IES-R ≥33 points. Rate of patients with a functional disability is defined as a score on the GOS-E≤6 points. Functional independence status (yes or no) evaluated on the FIM scale.

CAM-ICU, Confusion Assessment Method for Intensive Care Unit; FAB, Frontal Assessment Battery; FIM, Functional Independence Measurement; GOS-E, Glasgow Outcome Scale-Extended; IESR, Impact of Events Scale-Revised; MV, mechanical ventilation; PR, Physical Restraints; RASS, Richmond Agitation Sedation Scale; SOMS, Surgical intensive care unit Optimal Mobilisation Score .