Table 2.
Proposed presentation of baseline characteristics.
| Characteristic | Conservative oxygen therapy (n = xxxx) | Liberal oxygen therapy (n = xxxx) |
|---|---|---|
| Age, yr | xx.x ± xx | xx.x ± xx |
| Male sex, no. (%) | xxx (xx.x) | xxx (xx.x) |
| Body mass index | xx.x ± xx | xx.x ± xx |
| Clinical frailty score | xxx (xx.x) | xxx (xx.x) |
| Source of admission to ICU, no. (%) | ||
| Emergency department | xxx (xx.x) | xxx (xx.x) |
| Hospital ward | xxx (xx.x) | xxx (xx.x) |
| Transfer from another ICU | xxx (xx.x) | xxx (xx.x) |
| Transfer from another hospital (except from another ICU) | xxx (xx.x) | xxx (xx.x) |
| From OT following surgery | xxx (xx.x) | xxx (xx.x) |
| Hours from hospital admission to randomisation | xx.x ± xx | xx.x ± xx |
| Hours from ICU admission to randomisation | xx.x ± xx | xx.x ± xx |
| APACHE-II scorea | xx.x ± xx | xx.x ± xx |
| SAPS-III scoreb | ||
| Sepsis source, no. (%) | ||
| Respiratory | xxx (xx.x) | xxx (xx.x) |
| Gastrointestinal | xxx (xx.x) | xxx (xx.x) |
| Genitourinary | xxx (xx.x) | xxx (xx.x) |
| Musculoskeletal and skin | xxx (xx.x) | xxx (xx.x) |
| Other | xxx (xx.x) | xxx (xx.x) |
| COVID-19, no. (%) | xxx (xx.x) | xxx (xx.x) |
| Baseline oxygen data | ||
| FiO2 | xx.x ± xx | xx.x ± xx |
| PaO2, mmHg | xx.x ± xx | xx.x ± xx |
| PaO2/FiO2 ratio, mmHg | xx.x ± xx | xx.x ± xx |
Plus-minus values will be expressed as mean ± SD (where the distribution of the data is not symmetric, median [IQR] will be reported instead of mean ± SD). To facilitate meaningful interpretation of categorical variables, categories with small numbers (<10) will be collapsed for analysis.
Abbreviations: APACHE: Acute Physiology and Chronic Health Evaluation; CNS: central nervous system; ICU: intensive care unit; IQR: interquartile range; OT: operating theatre; SpO2: arterial oxygen saturation on pulse oximetry; PaO2: arterial partial pressure of oxygen; FiO2: fraction of inspired oxygen; PaCO2: arterial partial pressure of carbon dioxide; PEEP: positive end-expiratory pressure; SD: standard deviation.
Scores on the APACHE-II range from 0 to 71, with higher scores indicating more severe disease and a higher risk of death.
Scores on the SAPS-III range from 0 to 217, with higher scores indicating more severe disease. The SAPS-III score was collected from trial participants from Brazil.