Table 2.
Outcomes
| Control (n = 590) | Oversedation prevention (n = 584) | P value | Hazard ratio (95% confidence interval) | |
|---|---|---|---|---|
| 28-day mortality | 198 (33.6) | 177 (30.4) | 0.24a | |
| 90-day mortality | 261 (44.2) | 230 (39.4) | 0.09a | |
| 1-year mortality | 296 (60.0) | 267 (56.5) | 0.26a | |
| Mechanical ventilation-free days at day 28 (days), median (Q1–Q3) | 14 (0–24) | 16 (0-24) | 0.36b | |
| Ventilator-associated pneumonia, n | 92 | 94 | 0.79c | 1.04 (0.78; 1.38) |
| Mechanical ventilation ≥ 48 h, n (%) | 425 (72.0) | 418 (71.6) | 0.86a | |
| Non-invasive ventilation after extubation, n (%) | 152 (25.8) | 177 (30.3) | 0.08a | |
| Duration of non-invasive ventilation after extubation (days), median (Q1–Q3) | 2 (1–4) | 3 (2–4) | 0.05b | |
| Tracheostomy, n | 26 | 24 | 0.81c | 0.93 (0.54; 1.62) |
| Delirium, n | 232 | 230 | 0.99c | 1.00 (0.84; 1.19) |
| Proximal weakness after awakening, n | 193 | 208 | 0.26c | 1.11 (0.92; 1.35) |
| Patients with intravenous midazolam, n (%) | 464 (78.6) | 419 (71.8) | 0.01a | |
| Cumulative dosage of midazolam (mg), median (Q1–Q3) | 263 (120–660) | 218 (72–696) | 0.03b | |
| Patients with intravenous propofol, n (%) | 232 (39.3) | 214 (36.6) | 0.34a | |
| Cumulative dosage of propofol (mg), median (Q1–Q3) | 2785 (645–7140) | 1443 (120–4800) | < 0.001b | |
| Patients with intravenous morphinics, n (%) | 501 (84.9) | 482 (82.5) | 0.31a | |
| Patients with IV sufentanil, n (%) | 263 (44.6) | 241 (41.3) | 0.28a | |
| Cumulative dosage of sufentanil (µg), median (Q1–Q3) | 930 (472–2592) | 870 (280-2160) | 0.04b | |
| Patients with IV fentanyl, n (%) | 204 (34.6) | 206 (35.3) | 0.8a | |
| Cumulative dosage of fentanyl (µg), median (Q1–Q3) | 4985 (2400–15,445) | 4656 (1340–16,200) | 0.29b | |
| Patients with IV morphine, n (%) | 73 (12.4) | 91 (15.6) | 0.1a | |
| Cumulative dosage of morphine (mg), median (Q1–Q3) | 17.5 (7–55) | 20 (6–43) | 0.69b | |
| Patients with IV remifentanil, n (%) | 49 (8.3) | 45 (7.7) | 0.7a | |
| Cumulative dosage of remifentanil (µg), median (Q1–Q3) | 14,400 (6000–28,800) | 7200 (3000-19,200) | 0.05b | |
| Self-extubation, n | 48 | 70 | 0.03c | 1.50 (1.04; 2.16) |
| Ventricular tachycardia or fibrillation, n | 18 | 21 | 0.61c | 1.18 (0.63; 2.11) |
| Acute coronary syndrome or myocardial infarction, n | 7 | 8 | 0.77c | 1.16 (0.42; 3.18) |
| Cardiac arrest, n | 20 | 13 | 0.22c | 0.65 (0.33; 1.31) |
For comparison of time dependent events analyzed using competing risks models to take into account competing risks as death or extubation (e.g. ventilator associated pneumonia), no percentages are provided
For comparison of variables in post-randomization sub-group (e.g. ICU length of stay in survivors), no P values are provided
CI, confidence interval; Q1–Q3, 1st and 3rd quartiles; MV, mechanical ventilation; VAP, ventilator-associated pneumonia; NIV, non-invasive ventilation; ICU, intensive care unit; LOS, length of stay
aVariables compared using the chi-square test
bVariables compared using the Wilcoxon test
cVariables analyzed using competing risks models to take into account competing risks (as death, extubation, ICU discharge, …). For each of these outcomes, Gray test P value and hazard ratio (95% confidence interval) from competing risks models were presented