Strøm 2010.

Methods	Single‐centre, randomized controlled trial Setting: general ICU (18 beds medical and surgical) Country: Denmark Groups: No sedation vs. sedation Period: April 2007 to December 2008
Participants	Sample size: 140 (55/58) Included Need of mechanical ventilation for more than 24 hours Excluded Younger than 18 years of age Increased intracranial pressure Need of sedation for status epilepticus Hypothermia after cardiac arrest Pregnancy Met the department's criteria for weaning from the ventilator No cerebral contact Missing: 27 excluded after randomization, flowchart accounts for all patients
Interventions	Intervention: no sedation and treatment only with analgesics Control: sedation with daily interruption until awake
Outcomes	Primary Number of days without mechanical ventilation within a 28‐day period Secondary Number of needed CT or MRI brain scans Accidental removal of endotracheal tubes Ventilator‐assisted pneumonia, Additional reporting: in‐hospital mortality, delirium, ICU LOS Measured by: twice daily using criteria from diagnostic and statistical manual of mental disorders (DSM‐IV). Adverse events: accidental removal of endotracheal tube n = 7 in intervention group, and n = 6 in control
Notes	Conclusions: patients without sedation had significantly more days without ventilation and shorter ICU length of stay, hyperactive delirium was more frequent in the intervention group (20% vs 7%, P = 0.04). Authors discuss that the CAM‐ICU would have enabled assessment of hypoactive delirium as well. Patients in the present study were invited to participate in a follow‐up interview study that aimed to explore long‐term psychological effects of the intervention. Funding: Danish Society of Anesthesiology and Intensive Care Medicine, The Fund of Kirsten Jensa la Cour, The Fund of Danielsen, The Fund of Holger and Ruth Hess. None of these funds affected the trial or the paper according to the authors. Conflict of interest: no conflict declared Study number: NCT00466492 Contact with Author: none
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	Random selection of opaque sealed envelopes in a box
Allocation concealment (selection bias)	Low risk	Sealed envelopes in a box with 140 envelopes
Incomplete outcome data (attrition bias) All outcomes	Low risk	Flowchart accounts for all patients throughout the study
Selective reporting (reporting bias)	Low risk	In the online protocol, NCT00466492, the more long‐term psychological effects were planned to be reported; these outcomes were reported in a later paper Strøm 2011
Other bias	Low risk	Low risk of other potential biases
Blinding of participants and personnel (performance bias) All outcomes	High risk	No blinding of patients, clinicians, study personnel
Blinding of outcome assessment (detection bias) All outcomes	High risk	Outcome assessors were not blinded