Table 4.
Proposed presentation of outcomes.
| Conservative oxygen therapy (n = xxxx) | Liberal oxygen therapy (n = xxxx) | Estimate (95% CI) | |
|---|---|---|---|
| Primary outcomea | |||
| Died at the hospital by day 90, no. (%) | xxxx (xx.x) | xxxx (xx.x) | Relative risk xx (xx to xx) Risk difference xx (xx to xx) |
| Secondary outcomes | |||
| Hours until liberated from invasive mechanical ventilation alive | Subhazard ratio of time to extubationc | ||
| Number of patients | xxxx | xxxx | |
| Median (IQR)b | xx (xx–xx) | xx (xx–xx) | xx (xx to xx) |
| Days until discharged alive from ICU | Subhazard ratio of time to ICU dischargec | ||
| Number of patients | xxxx | xxxx | |
| Median (IQR)b | xx (xx–xx) | xx (xx–xx) | xx (xx to xx) |
| Days until discharged alive from hospital | Subhazard ratio of time to Hospital dischargec | ||
| Number of patients | xxxx | xxxx | |
| Median (IQR)b | xx (xx–xx) | xx (xx–xx) | xx (xx to xx) |
| Discharged home, no. (%) | xxxx (xx.x) | xxxx (xx.x) | Relative risk xx (xx to xx) Risk difference xx (xx to xx) |
| 90-Day mortality, no. (%) | xxx (xx.x) | xxx (xx.x) | Relative risk xx (xx to xx) Risk difference xx (xx to xx) |
Abbreviations: IQR: interquartile range; CI: confidence interval.
A P value for the primary outcome comparison will be shown in a footnote. The absolute difference in 90-day mortality and corresponding relative risk will be adjusted for the presence or absence of each of the following at randomisation: suspected hypoxic ischaemic encephalopathy following resuscitation from a cardiac arrest and acute brain pathologies other than hypoxic ischaemic encephalopathy.
Duration of invasive mechanical ventilation and ICU and hospital length of stay will be calculated from cumulative incidence functions with mortality regarded as a competing risk.
Ratios of median time to discharge (or extubation) will be estimated using censored linear regression with logarithm of time to discharge (or extubation) as the dependent variable. Adjustment will be made for the same variables as for the primary outcome.