Table 2.

Summary study data collected

Time points	Screening day 0	Randomisation day 0	Day 1–day 14	Discharge	Day 90
Description of time points	Within 6 hours after beginning of invasive MV		0–14	Day of ICU and hospital discharge	90 days after randomisation
Eligibility screen	X	X
Informed consent*		X
SAPS2	X	X
SOFA	X	X
Admission variables		x
Demographics		x
Comorbid conditions		x
Drug/alcohol consumption		X
Benzodiazepine treatment		X
Cognitive impairment		X
Braden scale		X
BPS		X	X
SARS-CoV-2 status	X
Main reason of IMV		X
Outcome variables
RASS (twice a day)		X	X
CAM-ICU (twice a day)		X	X
Sedatives (propofol, benzodiazepines and dexmedetomidine)			X
Opioids			X
Antipsychotics			X
Agitation
Self-extubation			X
Accidental removal of medical devices			X
Mobilisation by visual scale			X
Skin lesions			X
Length of stay (ICU and hospital)			X	X	X
Vital status			X	X	X
Follow-up consultation (mRS, MRC, MMS-E, FAB, IES-R, GOS-E, FIM, IPREA scales)					X

*Not mandatory, emergency inclusion is authorised by the French authorities. In case of emergency inclusion, close relative and/or patient written informed consents will be collected as soon as possible.

BPS, Behavioural Pain Scale; CAM-ICU, Confusion Assessment Method for the ICU; FAB, Frontal Assessment Battery; FIM, Functional Independence Measure; GOS-E, Glasgow Outcome Scale-Extended; ICU, intensive care unit; IES-R, Impact of Events Scale-revised; IPREA, Inconforts des Patients de REAnimation; MMSE, Mini-Mental State Evaluation; MRC, Medical Research Council Scale; mRS, Modified Rankin Scale; MV, mechanical ventilation; RASS, Richmond Agitation Sedation Scale; SAPS2, Simplified Acute Physiology Score 2; SOFA, Sequential Organ Failure Assessment.