| Bias | Author's judgement | Support for judgement |
| Randomization |
Low |
Quote:"Eligible patients fulfilling all inclusion criteria and no exclusion criteria are randomised 1:1 using a centralised web-based system according to a computer-generated allocation sequence list, the stratification variables (trial site, invasive mechanical ventilation [y/n], age <70 years [y/n]) using varying block sizes. The allocation sequence list and block sizes are only known by the data manager at the Copenhagen Trial Unit and remain concealed from the investigators until the trial database has been closed, the data analysed and the abstract for the trial report written in two versions."
Comment: Allocation sequence random. Allocation sequence concealed |
| Deviations from intervention |
Low |
Comment: quadruple blinded study. |
| Missing outcome data |
Low |
Comment: 39 patients randomized/ 39 patients analyzed.
Risk assessed to be low for the outcome: Mortality |
| Measurement of the outcome |
Low |
Comment: quadruple blinded study.
Risk assessed to be low for the outcomes: Mortality. |
| Selection of the reported results |
Low |
Comment: The protocol, statistical analysis plan, registry were available.
Results were not selected from multiple outcome measurements or analyses of the data. Trial analyzed as pre-specified. Risk assessed to be low for the outcomes: Mortality. |
| Overall risk of bias |
Low |